整理卡格净列说明书_附件1
恩列格净片说明书
恩列格净片说明书1. 产品介绍恩列格净片是一种针对皮肤问题的药膜贴片。
它采用了先进的技术，通过渗透和吸附作用，有效清除皮肤表面的污垢和杂质，改善肌肤质量，使皮肤更加健康和光滑。
2. 使用方法步骤1：准备工作在使用恩列格净片前，请确保脸部已经清洁干净，并且没有任何化妆品残留。
步骤2：取出净片从包装袋中取出一张恩列格净片。
每张净片都是独立包装的，确保卫生安全。
步骤3：粘贴净片将恩列格净片轻轻粘贴在需要处理的部位上。
可以根据个人需求剪裁合适大小的净片。
确保净片与皮肤充分接触，并且不会滑落。
步骤4：按摩使用指尖轻轻按摩净片，帮助其更好地吸附污垢和杂质。
按摩时间可以根据个人需要，一般建议约5-10分钟。
步骤5：取下净片完成按摩后，轻轻撕下净片，然后用清水洗净皮肤。
注意不要过度拉扯皮肤，以免造成刺激。
步骤6：保养使用恩列格净片后，可以继续进行日常的护肤步骤，如涂抹乳液或面霜等。
这样可以进一步滋润和保护皮肤。
3. 主要成分恩列格净片采用了多种有效成分，包括：•活性炭：具有吸附作用，能够有效去除皮肤表面的污垢和杂质。
•薄荷提取物：具有清凉舒缓的作用，能够缓解皮肤不适感。
•水解胶原蛋白：富含胶原蛋白的精华能够滋养和修复皮肤。
这些成分经过科学配比和严格筛选，在使用时不会对皮肤造成任何负面影响。
4. 注意事项•请避免使用在受伤、溃疡或其他异常皮肤部位。
•如出现皮肤不适或过敏，请立即停止使用并咨询医生。
•请将恩列格净片放置在干燥阴凉的地方，避免阳光直射。
•请勿将恩列格净片吞食或接触到眼睛。
5. 效果评估经过多次临床测试和用户反馈，恩列格净片在改善皮肤质量方面表现出色。
使用者普遍反映，恩列格净片能够清除皮肤上的污垢和杂质，使皮肤更加光滑和细腻。
长期使用还可以改善肌肤弹性和亮度。
6. 常见问题解答Q1: 恩列格净片适合哪种类型的皮肤使用？A1: 恩列格净片适用于各种类型的皮肤，包括油性、干性、混合性等。
它不会造成任何刺激或干扰正常的皮肤功能。
达格列净片 FARXIGA (dapagliflozin) FDA药品说明书翻译
FULL PRESCRIBING INFORMATION1 INDICATIONS AND USAGE 适应症和用途FARXIGA (dapagliflozin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14)].本药用于配合饮食控制和运动改善2型糖尿病患者的血糖控制。
1.1 Limitation of Use 使用限制FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.本药不适用于1型糖尿病或糖尿病酮症酸中毒患者。
2 DOSAGE AND ADMINISTRATION 用法用量2.1 Recommended Dosing 推荐剂量The recommended starting dose of FARXIGA is 5 mg once daily, taken in the morning, with or without food. In patients tolerating FARXIGA 5 mg once daily who require additional glycemic control, the dose can be increased to 10 mg once daily.推荐起始剂量为一次5mg，一日1次，早晨服用，可与或不与食物同服。
对本药一次5mg，一日1次剂量耐受且须更多血糖扩指着，可增至一次10mg，一日1次。
In patients with volume depletion, correcting this condition prior to initiation of FARXIGA is recommended [see Warnings and Precautions (5.1), Use in Specific Populations (8.5, 8.6), and Patient Counseling Information (17)].血容量减少患者，推荐用药前应先纠正血容量减少。
恩列格净片说明书
恩列格净片说明书首部内容：恩列格净片说明书引言：恩列格净片是一种常见的药物，被广泛用于治疗各种疾病和症状。
本说明书将详细介绍恩列格净片的药物成分、用途、剂量、注意事项等信息，以帮助患者正确使用本药物并避免不必要的风险。
一、药物成分：恩列格净片的主要成分为X物质和Y物质。
X物质具有抗炎作用，可以有效缓解疼痛和红肿；Y物质则具有抗菌作用，能够抑制细菌和病毒的生长。
这两种成分的协同作用使得恩列格净片成为一种非常有效的药物。
二、适用症：恩列格净片适用于治疗多种疾病和症状，包括但不限于以下方面：1. 感冒症状：如流鼻涕、咳嗽、喉咙痛等。
2. 发热状况：如高热、低热等。
3. 炎症反应：如关节炎、扁桃体炎等。
4. 细菌感染：如皮肤感染、尿路感染等。
三、使用方法：1. 用法：口服，建议饭后服用，以提高药效。
2. 剂量：成人每次口服1片，每日2次；儿童剂量请咨询医生。
3. 服用时间：按照医生或药剂师的指示进行规定疗程的用药。
4. 注意事项：饮食清淡，避免食用辛辣、油腻食物；避免与其他药物同时使用，以免发生不良反应。
四、不良反应：恩列格净片在正常剂量下通常是安全有效的，但仍可能出现一些不良反应，包括但不限于以下症状：1. 胃部不适：如恶心、呕吐等。
2. 过敏反应：如皮疹、瘙痒、面部肿胀等。
3. 肠胃功能异常：如腹泻、便秘等。
请在使用药物过程中密切关注身体状况，如出现异常症状，请及时就医。
五、注意事项：1. 孕妇、哺乳期妇女、儿童应在医生指导下使用。
2. 对恩列格净片成分过敏者禁用，请提前了解药物成分并遵循医生的建议。
3. 使用期间注意饮食卫生，避免感染和交叉感染。
4. 若出现过敏反应或不良症状，请立即停药并咨询医生。
六、贮藏：请将恩列格净片放置在阴凉、干燥处，避免阳光直射和潮湿环境。
结语：恩列格净片是一种安全有效的药物，适用于多种疾病和症状的治疗。
在使用时，请仔细阅读本说明书并遵循医生的建议，如有任何问题或不良反应，请及时告知医生。
ColiComplete 产品说明书
Page 1 of 2 ColiComplete ®AOAC Official Method 992.30General DescriptionColiComplete ® contains 5-bromo-4-chloro-3-indolyl-ß-Dgalactopyranoside (X-Gal) and 4-methyl umbelliferyl-ß-D-glucuronide (MUG). Discs are added to LST inoculated with selected dilutions of samples. Samples are incubated at 35–37 °C and examined after 24 and 48 ±2 h for confirmed total coliforms and after 30 ±2 h for confirmed E. coli results. ß-Galactosidase, from coliforms present in samples, cleaves X-Gal into 5-bromo-4-chloro-indoxyl intermediate which undergoes oxidation to yield water-insoluble blue dimer, visually detectable on disc or in surrounding medium as confirmed positive result for total coliform activity. ß-Glucuronidase, from E. coli present in samples, cleaves MUG into glucuronide and methyl umbelliferone which fluoresces under long wave UV light (366 nm) as confirmed positive result for E. coli presence.NOTE : As E. coli O157:H7 does not produce ß-glucuronidase, ColiComplete ® is not suitable for the detection of E. coli O157:H7.A. Sample PreparationPrepare appropriate serial dilutions as indicated in FDA Bacteriological Analytical Manual (BAM), or AOAC Official Methods of Analysis according to sample type.B. InoculationInoculate LST tubes with appropriate sample dilution series selected to determine MPN levels or presence/absence of total coliforms and E. coli in sample. Aseptically add a single ColiComplete ® disc to each tube. Incubate at 35–37 °C.C. Reading ColiComplete ®a. For total coliforms — After at least 24 h incubation, examine each tube for visually detectable blue color on disc or in surrounding medium. Presence of blue color indicates confirmed positive result for total coliforms.NOTE: A wide range of blue color intensity may be expected, depending on sample composition and microflora. All blue reactions are positive regardless of intensity of color.Reincubate at 35–37 °C. After additional 24 ±2 h re-examine. Continued absence of blue indicates negative result; presence of blue indicates confirmed positive result for total coliforms. Read and record the MPN code or presence/absence of total coliforms in the sample.b. For E.coli — After 30 ±2 h from start of initial incubation, examine tubes under long-wave UV light (366 nm). Fluorescent tubes indicate confirmed positive result for E. coli. Read and record the MPN code or presence/absence of E. coli in the sample.D. CONTROLSPositive and negative controls should be used to facilitate interpretation of MUG fluorescent reaction. Use one known positive E. coli tube and two negative controls - one non -E. coli /coliform tube (e.g., Klebsiella spp.) and one uninoculated media tube.NOTE: Use borosilicate glass tubes, flint glass gives fluorescence that may be misinterpreted for a positive result.Lit. No. MK_UG4655EN Merck KGaAFrankfurter Strasse 25064293 DarmstadtGermanyPage 2 of 2 E. Method Modification for Certain JuicesApplicable to juice products/processors which rely on treatments that do not come into direct contact with all parts of the juice, as contained in 21 CFR Part 120: Rules and Regulations. Hazard Analysis and Critical Control Point (HAACP); Procedures for the Safe and Sanitary Processing and Importing of Juice; Final Rule. Vol 66 No. 13. 6137-6202. Use the modified method “Analysis for Escherichia coli in Citrus Juices - Modifi cation of AOAC Official Method 992.30” as stated in Section 120.25 (a).F. StorageStore unused discs at 2–8 °C (36–46 °F) in a sealed container, with desiccant.G. DisposalAfter use, all tubes must be steam-sterilized at 121 °C for at least 30 min before discarding. For in-vitro diagnostic use only.Manufacturing EntityBioControl Systems, Inc, 12822 SE 32nd St, Bellevue, WA 98005, USA.BioControl Systems, Inc is an affiliate of Merck KGaA, Darmstadt, Germany.。
BACGro Sabouraud Dextrose Agar (SDA) 产品说明书
Sabouraud Dextrose Agar - Instructions for UseIntended UseBAC Gro TM Sabouraud Dextrose Agar (SDA), when prepared as directed, is intended for use for the culture and isolation of yeasts and molds. Sabouraud Dextrose Agar is not intended for use in diagnosis, treatment, or prevention of disease in humans. BAC Gro TM Sabouraud Dextrose Agar conforms to harmonized USP/EP/JP requirements1-3.Product SummarySabouraud Dextrose Agar is a general purpose medium used for the cultivation and isolation of a wide variety of yeasts and molds. The low pH promotes growth of these fungi while simultaneously being slightly inhibitory to competing bacteria that may be present in a sample. Further selectivity can be achieved through the addition of antibiotic supplements.The media includes peptone to provide nitrogen and vitamins for the yeast and mold. Dextrose is included at a very high concentration to provide a carbon source for energy. Agar serves as the solidifying agent.Formulation* (per Liter)Peptone 10.0 gDextrose 40.0 gAgar 15.0 gTotal 65.0 g/L*Formula may be supplemented and/or adjusted as required to meet performance criteriaNote: Sabouraud Dextrose Agar with Chloramphenicol is also available, containing chloramphenicol at 100mg per LiterDirections1.Add 65.0 g of Sabouraud Dextrose Agar powder to 1L purified water.2.Heat and agitate to form aqueous solution.3.Autoclave at 121 degrees Celsius for 15 minutes.4.Cool prior to use.PrecautionsThis product is for laboratory use only and should only be used by qualified, trained laboratory personnel. Personnel should always use proper aseptic technique and observe all biohazardous precautions. All microbiological cultures should be presumed to be infectious.Avoid ingestion, inhalation, or contact with skin and mucous membranes. If contact occurs, flush the area with clean water.Quality Control SpecificationsGold Standard Diagnostics tests each lot of manufactured BAC Gro TM culture media utilizing appropriate control organisms and specifications as documented on the Certificate of Analysis. End users should perform quality control testing in accordance with government regulatory requirements and accreditation guidelines. The following specifications are routinely used for testing:Appearance (dehydrated): Light beige, homogenous, free flowing powder, free of debris Appearance (prepared): Clear to hazy, amber, with no precipitate or debrispH (prepared): 5.4 – 5.8 at 25°COrganism Performance:Limitations of the ProcedureThis product is not labeled for use as a medical device, and is not intended to diagnose, treat, or prevent disease.Due to variation in nutritional requirements, some strains may be encountered that grow poorly in this medium.Antimicrobial agents that are added to a medium may inhibit the growth of fungal pathogens.Acidic media should avoid being overheated; this will result in a softer mediumStorage and ExpirationBAC Gro TM Sabouraud Dextrose Agar should be stored at 2 – 30 degrees Celsius. Because of the hygroscopic nature of dehydrated culture media, it should be stored in a dry place and the lid should remain tightly sealed. Media should be discarded if it is not free flowing or shows discoloration.The expiration date printed on the label is applicable to media stored as directed.Catalog NumbersDCM3701 – Sabouraud Dextrose Agar, 500gDCM3710 – Sabouraud Dextrose Agar, 10 kgDCM3805 – Sabouraud Dextrose Agar with Chloramphenicol, 5kgDCM3810 – Sabouraud Dextrose Agar with Chloramphenicol, 10kg1 United States Pharmacopeial Convention. United States Pharmacopoeia and National Formulary (USP-NF).2 Directorate for the Quality of Medicines and the Council of Europe. The European Pharmacopoeia.3 Pharmaceuticals and Medical Devices Agency, Ministry of Health, Labor, and Welfare. Japanese Pharmacopoeia.。
整理卡格净列说明书_附件
附件192个药物临床试验数据自查核查注册申请清单附件1食品中二甲双胍等非食品用化学物质的测定BJS 201901•范围本标准规定了食品（含特殊食品）中二甲双胍、苯乙双胍、丁二胍、伏格列波糖、阿卡波糖、维达列汀、罗格列酮、西他列汀、吡格列酮、氯磺丙脲、达格列净、格列吡嗪、甲苯磺丁脲、醋磺己脲、妥拉磺脲、瑞格列奈、卡格列净、格列齐特、格列波脲、格列本脲、那格列奈、格列美脲、曲格列酮、格列喹酮、莫格他唑、GW501516、环格列酮等27种非食品用化学物质的高效液相色谱-串联质谱测定方法。
本标准适用于茶叶、奶粉、饼干、酒、饮料等食品（包括上述类似基质的片剂、胶囊剂等形式的特殊食品）中二甲双胍等27种非食品用化学物质的测定。
•原理试样粉碎后经甲醇超声提取，过滤后，上清液供高效液相色谱-串联质谱测定，外标法定量。
•试剂和材料除另有规定，本方法所用试剂均为分析纯或以上规格，水为GB/T 6682规定的一级水。
3.1 试剂3.1.1 乙腈（CH3CN）：色谱纯。
3.1.2 甲酸（HCOOH）：色谱纯。
3.1.3 甲酸铵（HCOONH4）：色谱纯。
3.1.4 甲醇（CH3OH）：分析纯。
3.2溶液配制3.2.1 0.1%甲酸水溶液：量取甲酸（3.1.2）1 mL，用水稀释至1000 mL，用滤膜（4.2）过滤后备用。
3.2.2 5 mmol/L甲酸铵水溶液：称取甲酸铵（3.1.3）0.315 g，用水稀释至1000 mL，用滤膜（4.2）过滤后备用。
3.2.3 5 mmol/L甲酸铵乙腈溶液：称取甲酸铵（3.1.3）0.315 g，加水50 mL溶解后，用乙腈稀释至1000 mL，用滤膜（4.2）过滤后备用。
3.3标准品苯乙双胍、丁二胍、二甲双胍、伏格列波糖、阿卡波糖、维达列汀、罗格列酮、西他列汀、吡格列酮、氯磺丙脲、达格列净、格列吡嗪、甲苯磺丁脲、醋磺己脲、妥拉磺脲、瑞格列奈、卡格列净、格列齐特、格列波脲、格列本脲、那格列奈、格列美脲、曲格列酮、格列喹酮、莫格他唑、GW501516、环格列酮标准品的中文名称、英文名称、CAS登录号、分子式、相对分子质量详见附录A中的表A.1，各标准品纯度均≥95%。
Jevtana 和 Cabazitaxel 产品说明书
Cabazitaxel:Jevtana®; Cabazitaxel§(Intravenous)Document Number: IC‐0074 Last Review Date: 02/02/2023Date of Origin: 01/2012Dates Reviewed: 06/2012, 09/2012, 12/2012, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014,09/2014, 12/2014, 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 02/2017,05/2017, 08/2017, 11/2017, 02/2018, 05/2018, 04/2019, 04/2020, 04/2021, 04/2022, 02/2023I.Length of AuthorizationCoverage will be provided for 6 months and may be renewed.II.Dosing LimitsA.Quantity Limit (max daily dose) [NDC unit]:-Jevtana 60 mg solution for injection, single-dose vial: 1 vial per 21 day supply-Cabazitaxel 45 mg/4.5 mL solution for injection, multiple-dose vial: 1 vial per 21 day supply-Cabazitaxel 60 mg/6 mL solution for injection, multiple-dose vial: 1 vial per 21 day supplyB.Max Units (per dose and over time) [HCPCS Unit]:-Jevtana: 60 billable units per 21 days-Cabazitaxel: 50 mg per 21 daysIII.Initial Approval Criteria 1,2Coverage is provided in the following conditions:∙Patient is at least 18 years of age; ANDUniversal Criteria 1-4∙Must be used in combination with a steroid (e.g. prednisone or dexamethasone); AND∙Patient does not have severe hepatic impairment (e.g., total bilirubin > 3 times the upper limit of normal); ANDProstate Cancer † 1-4∙Patient has castration-resistant metastatic adenocarcinoma; ANDo Used as a single agent †; AND▪Patient must have been previously treated with docetaxel unless not a candidate for or intolerant to docetaxel; ORo Used in combination with carboplatin ‡; AND▪Used for fit patients with aggressive variant disease (e.g., visceral metastases, low prostate-specific antigen and bulky disease, high LDH, high CEA, lytic bonemetastases, neuroendocrine prostate cancer histology) or unfavorable genomics(e.g., defects in at least two of the following: PTEN, TP53, and RB1); ANDPatient has received prior docetaxel and no prior novel hormone therapy(e.g., abiraterone, enzalutamide, darolutamide, apalutamide, etc.); ORPatient has received prior novel hormone therapy and no prior docetaxel; ORPatient has received prior docetaxel and prior novel hormone therapy; AND -Patient does not have visceral metastases; OR∙Patient has castration-resistant metastatic small cell/neuroendocrine prostate cancer;ANDo Used in combination with carboplatin; ANDo Used for fit patients with aggressive variant disease (e.g., visceral metastases, low prostate-specific antigen and bulky disease, high LDH, high CEA, lytic bonemetastases, neuroendocrine prostate cancer histology) or unfavorable genomics (e.g.,defects in at least two of the following: PTEN, TP53, and RB1)† FDA Approved Indication(s); ‡ Compendia recommended indication(s); Ф Orphan DrugIV.Renewal Criteria 1,2Coverage can be renewed based upon the following criteria:∙Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performancestatus, etc. identified in section III; AND∙Disease response with treatment as defined by lack of disease progression, improvement in tumor size and/or improvement in patient symptoms; AND∙Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: bone marrow suppression (neutropenia, anemia, thrombocytopenia, and/or pancytopenia), severe hypersensitivity reactions, gastrointestinal adverse reactions (severe diarrhea,nausea, vomiting), urinary disorders including severe hemorrhagic cystitis, renal failure,hepatic impairment, respiratory disorders (interstitial pneumonia/pneumonitis, interstitial lung disease, acute respiratory distress syndrome), etc.V.Dosage/Administration 1,2Prostate Cancer JevtanaAdminister 20-25 mg/m², intravenously, every 3 weeks in combination with an oral corticosteroidCabazitaxelAdminister 20 mg/m², intravenously, every 3 weeks in combination with an oral corticosteroidVI.Billing Code/Availability InformationHCPCS code:∙J9043 – Injection, cabazitaxel, 1 mg: 1 billable unit= 1 mg (Jevtana ONLY)∙J9999 – Not otherwise classified, antineoplastic drugs (Cabazitaxel ONLY)NDC:∙Jevtana 60 mg/1.5 mL solution for injection, single-dose vial: 00024-5824-xx∙Cabazitaxel 45 mg/4.5 mL solution for injection, multiple-dose vial: 00781-3186-xx §∙Cabazitaxel 60 mg/6 mL solution for injection, multiple-dose vial: 00781-3193-xx §§ Designated products approved by the FDA as a 505(b)(2) NDA of the innovator product. These products are not rated as therapeutically equivalent to their reference listed drug in the Food and Drug Administration’s (FDA) Orange Book and are therefore considered single source products based on the statutory definition of “single source drug” in section 1847A(c)(6) of the Act. For a complete list of all approved 505(b)(2) NDA products please reference the latest edition of the Orange Book:Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book | FDAVII.References1.Jevtana [package insert]. Bridgewater, NJ; Sanofi-Aventis U.S. LLC; February 2021.Accessed January 2023.2.Cabazitaxel [package insert]. Princeton, NJ; Sandoz Inc.; January 2023. Accessed January20233.Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCNCompendium®) for cabazitaxel. National Comprehensive Cancer Network, 2023. TheNCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONALCOMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® aretrademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to . Accessed January 2023.4.Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCNCompendium®) for Prostate Cancer 1.2023. National Comprehensive Cancer Network,2023. The NCCN Compendium® is a derivative work of the NCCN Guidelines®.NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCNGUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to. Accessed January 2023.5.Fahrenbruch R, Kintzel P, Bott AM, et al. Dose Rounding of Biologic and CytotoxicAnticancer Agents: A Position Statement of the Hematology/Oncology PharmacyAssociation. J Oncol Pract. 2018 Mar;14(3):e130-e136.6.de Bono JS, Oudard S, Ozguroglu M, et al; TROPIC Investigators. Prednisone pluscabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomized open-label trial. Lancet 2010. Oct2;376(9747):1147-54. doi: 10.1016/S0140-6736(10)61389-X.7.Sartor AO, Oudard S, Sengelov L, et al. Cabazitaxel vs docetaxel in chemotherapy-naive(CN) patients with metastatic castration-resistant prostate cancer (mCRPC): A three-arm phase III study (FIRSTANA). Journal of Clinical Oncology34, no. 15_suppl(May 20,2016)5006-5006. DOI: 10.1200/JCO.2016.34.15_suppl.5006.8.Fizazi K, Kramer G, Eymard JC, et al. Quality of life in patients with metastatic prostatecancer following treatment with cabazitaxel versus abiraterone or enzalutamide (CARD): an analysis of randomized multicentre, open-label, phase 4 study. Lancet Oncol. 2020Nov;21(11):1513-1525. doi: 10.1016/S1470-2045(20)30449-6.9.Eisenberger M, Hardy-Bessard AC, Kim CS, et al. Phase III Study Comparing a ReducedDose of Cabazitaxel (20 mg/m2) and the Currently Approved Dose (25 mg/m2) inPostdocetaxel Patients With Metastatic Castration-Resistant Prostate Cancer-PROSELICA. J Clin Oncol. 2017 Oct 1;35(28):3198-3206. doi: 10.1200/JCO.2016.72.1076. Appendix 1 – Covered Diagnosis Codes1010C61 Malignant neoplasm of prostateC7A.1 Malignant poorly differentiated neuroendocrine tumorsC7A.8 Other malignant neuroendocrine tumorsAppendix 2 – Centers for Medicare and Medicaid Services (CMS)Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs) and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https:///medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/AJurisdiction Applicable State/US Territory ContractorE (1) CA, HI, NV, AS, GU, CNMI Noridian Healthcare Solutions, LLCF (2 & 3) AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ Noridian Healthcare Solutions, LLC5 KS, NE, IA, MO Wisconsin Physicians Service Insurance Corp (WPS)6 MN, WI, IL National Government Services, Inc. (NGS)H (4 & 7) LA, AR, MS, TX, OK, CO, NM Novitas Solutions, Inc.8 MI, IN Wisconsin Physicians Service Insurance Corp (WPS) N (9) FL, PR, VI First Coast Service Options, Inc.J (10) TN, GA, AL Palmetto GBA, LLCM (11) NC, SC, WV, VA (excluding below) Palmetto GBA, LLCNovitas Solutions, Inc.L (12) DE, MD, PA, NJ, DC (includes Arlington &Fairfax counties and the city of Alexandria in VA)K (13 & 14) NY, CT, MA, RI, VT, ME, NH National Government Services, Inc. (NGS)15 KY, OH CGS Administrators, LLC。
坎格列净片说明书简化版
Revised: XX/2013
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Renal Impairment 8.7 Hepatic Impairment
! Hypoglycemia: Consider a lower dose of insulin or the insulin secretagogue to reduce the risk of hypoglycemia when used in combination with INVOKANA (5.4)
10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of
------------------------------ADVERSE REACTIONS------------------------------! Most common adverse reactions associated with INVOKANA (5% or
greater incidence): female genital mycotic infections, urinary tract infection, and increased urination (6.1)
Zulresso（Brexanolone）商品说明书
UnitedHealthcare ® Community PlanZulresso ® (Brexanolone)Policy Number : CS2023D0080J Effective Date : November 1, 2023 Instructions for UseTable of Contents Page Application ..................................................................................... 1 Coverage Rationale ....................................................................... 1 Applicable Codes .......................................................................... 2 Background .................................................................................... 2 Clinical Evidence ........................................................................... 2 U.S. Food and Drug Administration ............................................. 3 References ..................................................................................... 3 Policy History/Revision Information ............................................. 3 Instructions for Use ....................................................................... 3 This Medical Benefit Drug Policy does not apply to the states listed below; refer to the state-specific policy/guideline, if noted: StatePolicy/GuidelineFloridaRefer to the state’s Medicaid clinical policyIndiana Zulresso ® (Brexanolone) (for Indiana Only)Kansas None LouisianaRefer to the state’s Medicaid clinical policy North CarolinaNone OhioZulresso ® (Brexanolone) (for Ohio Only)TexasRefer to the drug specific criteria found within the Texas Medicaid Provider Procedures ManualZulresso (brexanolone) is proven and medically necessary for the treatment of postpartum depression in patients who meet all of the following criteria :Diagnosis of major depressive disorder (MDD) according to the current DSM (i.e., DSM-5), by a mental health professional; andOnset of current depressive episode was during the third trimester or within 4 weeks postpartum; andCurrent depressive episode is considered moderate to severe based on a standardized, validated tool; andPatient has not previously received Zulresso (brexanolone) for the current postpartum depressive episode from the most recent pregnancy (within 6 months); andPatient has not previously received Zurzuvae (zuranolone) for the current postpartum depressive episode from the most recent pregnancy (within 6 months); andThe provider and/or the provider’s healthcare setting is certified in the Zulresso REMS program, with ability to support onsite continuous monitoring; andBrexanolone is dosed in accordance with the United States Food and Drug Administration (FDA)-approved labeling; and Commercial Policy • Zulresso ® (Brexanolone)Approval is for a single 60-hour infusionThe following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by federal, state, or contractual requirements and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Guidelines may apply.HCPCS Code DescriptionJ1632 Injection, brexanolone, 1 mgDiagnosis Code DescriptionF53.0 Postpartum depressionBrexanolone is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator, that is chemically identical to endogenous allopregnanolone.Meltzer-Brody et al. assessed brexanolone as a treatment for moderate to severe postpartum depression (PPD) in two double-blind, randomized, placebo-controlled, phase 3 trials.2 Women in the trial were 18-45 years of age, 6 months post-partum or less at screening, and diagnosed with PPD with a Hamilton Rating Scale for Depression (HAM-D) score of ≥ 26 and 20-25 for study 1 and study 2, respectively. Study participants were randomly assigned to receive either brexanolone 90 μg/kg per hr. (BRX90), brexanolone 60 μg/kg per hr. (BRX60), or matching placebo for a single 60-hour infusion in study 1. In study 2, BRX90 or placebo was infused as a single 60-hour infusion. The primary efficacy endpoint was the change from baseline in the 17-item HAM-D total score at 60 hours. This was assessed in all patients who started infusion of brexanolone or placebo, had a valid HAM-D baseline assessment, and had at least one post-baseline HAM-D assessment. The trials are NCT02942004 (study 1) and NCT02942017 (study 2). In study 1, at 60 hours, the least-squares (LS) mean reduction in HAM-D total score from baseline was 19.5 points (SE 1.2) in the BRX60 group and 17.7 points (1.2) in the BRX90 group compared with 14.0 points (1.1) in the placebo group [difference -5.5 (95% CI -8.8 to -2.2), p = 0.0013 for the BRX60 group; -3.7 (95% CI -6.9 to -0.5), p = 0.0252 for the BRX90 group]. In study 2, at 60 hours, the LS mean reduction in HAM-D total score from baseline was 14.6 points (SE 0.8) in the BRX90 group compared with 12.1 points (SE 0.8) for the placebo group [difference -2.5 (95% CI -4.5 to -0.5), p = 0·0160]. The authors conclude that brexanolone for PPD resulted in significant and clinically meaningful reductions in HAM-D total score at 60 hours compared with placebo, with rapid onset of action and durable treatment response during the study period. The authors conclude that results suggest that brexanolone injection is a novel therapeutic drug for PPD that has the potential to improve treatment options for women with this disorder.Brexanolone safety, tolerability, and pharmacokinetics were evaluated in a multicenter, open-label study in 20 patients aged 15 to 17 years diagnosed with PPD and were comparable to those in adult patients with PPD.1Professional SocietiesThe American College of Obstetricians and Gynecologists (ACOG) has published a clinical practice guideline with recommendations on treatment and management of perinatal mental health conditions including depression. ACOG recommends consideration of brexanolone administration in the postpartum period for moderate-to-severe perinatal depression with onset in the third trimester or within 4 weeks postpartum. The decision to use brexanolone should balance the benefits (e.g., rapid onset of action) with the risks and challenges (e.g., limited access, high cost, lack of data supporting safety with breastfeeding, requirement for inpatient monitoring during the infusion, lack of efficacy data beyond 30 days).(STRONG RECOMMENDATION, MODERATE-QUALITY EVIDENCE)This section is to be used for informational purposes only. FDA approval alone is not a basis for coverage.Zulresso is indicated for the treatment of postpartum depression (PPD) in patients 15 years and older.Zulresso is only available through a restricted program under a REMS called the Zulresso REMS due to the risk of excessive sedation or sudden loss of consciousness that can result in serious harm.Important requirements of the Zulresso REMS include the following:Healthcare facilities must enroll in the program and ensure that Zulresso is only administered to patients who are enrolled in the Zulresso REMSPharmacies must be certified with the program and must only dispense Zulresso to healthcare facilities who are certified inthe Zulresso REMSPatients must be enrolled in the Zulresso REMS prior to administration of ZulressoWholesalers and distributors must be registered with the program and must only distribute to certified healthcare facilities and pharmacies1.Zulresso [package insert]. Cambridge, MA: Sage Therapeutics; June 2022.2.Meltzer-Brody S, Colquhoun H, Riesenberg R, Epperson CN, Deligiannidis KM, Rubinow DR, Li H, Sankoh AJ, Clemson C,Schacterle A, Jonas J, Kanes S. Brexanolone injection in post-partum depression: two multicentre, double-blind,randomised, placebo-controlled, phase 3 trials. Lancet. 2018 Sep 22;392(10152):1058-1070.3.AAmerican Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. 2013. Washington,DC. Pages 451-459.4.Treatment and Management of Mental Health Conditions During Pregnancy and Postpartum: ACOG Clinical PracticeGuideline No. 5. Obstet Gynecol. 2023;141(6):1262-1288. doi:10.1097/AOG.0000000000005202.Date Summary of Changes11/01/2023 Coverage Rationale•Replaced references to “brexanolone” with “Zulresso (brexanolone)”•Revised coverage criteria:o Added criterion requiring the patient has not previously received Zurzuvae (zuranolone) for thecurrent postpartum depressive episode from the most recent pregnancy (within 6 months)o Replaced criterion requiring “onset of current depressive episode was during the third trimester and 4 weeks postpartum” with “onset of current depressive episode was during the thirdtrimester or within 4 weeks postpartum”Supporting Information•Updated Clinical Evidence and References sections to reflect the most current information•Archived previous policy version CS2022D0080IThis Medical Benefit Drug Policy provides assistance in interpreting UnitedHealthcare standard benefit plans. When deciding coverage, the federal, state, or contractual requirements for benefit plan coverage must be referenced as the terms of the federal, state, or contractual requirements for benefit plan coverage may differ from the standard benefit plan. In the event of a conflict, the federal, state, or contractual requirements for benefit plan coverage govern. Before using this policy, please check the federal, state, or contractual requirements for benefit plan coverage. UnitedHealthcare reserves the right to modify itsPolicies and Guidelines as necessary. This Medical Benefit Drug Policy is provided for informational purposes. It does not constitute medical advice.UnitedHealthcare may also use tools developed by third parties, such as the InterQual® criteria, to assist us in administering health benefits. The UnitedHealthcare Medical Benefit Drug Policies are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice.。
卡迪南健康产品介绍书说明书
Controlling infection and your costs Infection control apparelThe total approach to controlling costs.You look for every way to prevent infection — why not do the same to control costs? Once you look beyond product price alone, the opportunities are everywhere.When you collaborate with us, you can expect more than on-time deliveries of the products you want. We deliver something just as important: the insight to improve your product selection, inventory management and utilization — helping you reduce waste and needless cost.Using the science of Lean Six Sigma, we’re here to help balance your needs for quality and cost at the same time. At Cardinal Health, we’re helping you succeed in the healthcare world by providing the right products you need.What’s insideInfection control guide ......................................................1AAMI isolation gowns .......................................................3Isolation gowns ...............................................................4Poly-coated isolation gowns ...............................................7Chemotherapy gowns .......................................................9Non-sterile procedure gowns .............................................10Coveralls .......................................................................11Scrubwear and aprons ......................................................12Lab coats and lab jackets ..................................................13What to use whereThe icons represented below should be used as a guideline inmaking gown selections for various needs and areas of your facility. Additionally, utilize the AAMI chart (see page 2) for the appropriate level gown.Standard Precautions*Contact PrecautionsEmergency Food ServiceIntensive Care UnitLab Maintenance Nursing Radiology VisitorsSolutions that just make senseICU SP CP When is a gown more than a gown? When it becomes a smart and easy way to help control not only infection — but also your costs. Introducing Infection Control Apparel solutions from Cardinal Health. Engineered to help you think differently about what you buy, our Infection Control Apparel helps you focus on what matters most: keeping your clinicians and patients safe.*Per CDC Guidelines on Standard Precautions, the use of isolation gowns is indicated for some interactions between healthcare workers and patients. Transmission-Based Precautions (Contact, Droplet, and Airborne Precautions) are always used in addition to Standard Precautions. Isolation gowns are indicated for use whenever Contact Precautions are in effect, and may be appropriate when Droplet and/or Airborne Precautions are in effect, depending on the nature of the interaction between the healthcare worker and patient as well as the extent of anticipated blood, body fluid, or pathogen exposure.For more information, visit .Source: Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the Healthcare Infection Control Practices Advisory Committee, 2007 Guideline for Isolation Precautions: Preventing Transmission of InfectiousAgents in Healthcare SettingsTest definition Requirement353110PG79Chemotherapy gowns Poly-coated SMS chemotherapy gownsEngineered to provide users with protection from the potential hazardsassociated with handling chemotherapy agents.• Poly-coated material for durability and protection• Lightweight, closed-back design, secured with ties for maximum comfort• Low-linting material helps to provide a clean environment• Long sleeves with knit cuffs provide added comfortThe material used in these gowns has been tested against the followingchemotherapy drugs per ASTM F739-12 and no breakthrough was observedduring test duration of 480 minutes based on average standardizedbreakthrough time*:• Carmustine• Cisplatin• Cyclophosphamide• Dacarbazine• Doxorubicin Hydrochloride• Etoposide• Fluorouracil• Mitomycin C• Paclitaxel• Thiotepa• Vincristine SulfateThese generously sized gowns are compatible with OSHA (Occupational Safetyand Health Administration) recommendations, and ASHP (American Society ofHealth-System Pharmacists) and ONS (Oncology Nursing Society) guidelinesfor wearing a gown while preparing or handling chemotherapy drugs. Insummary, these organizations recommend that chemotherapy gowns are †:• Disposable• Lint-free• Made of low permeability fabric• Constructed with a solid front and back closure•Long sleeved with tight-fitting cuffs* T he material in these gowns has been tested against the chemotherapy drugs listed above per ASTM F739-12and no permeation was detected at either the minimum detectable permeation or 0.1 μg/cm2/min†Sources:OSHA Technical Manual, Section VI: Chapter 2Guidelines on Handling Dangerous Drugs – ASHPONS Chemotherapy and Biotherapy Guidelines and Recommendations for Practice (3rd ed., 2009)1113Cardinal Health Medical Products Waukegan, Illinois 。
克尔澈 3 8英寸x100英尺地毯立式空气筒梳理书说明书
3/8in. x 100ft. Floor Stand Air Hose ReelOwner’s ManualWARNING: Read carefully and understand all ASSEMBLY AND OPERATION INSTRUCTIONS before operating. Failure to follow the safety rules and other basic safety precautions may result in serious personal injury.Item #62303Thank you very much for choosing a Klutch™product!For future reference, please complete the owner’s record below:Serial Number/Lot Date Code: ________________________________ Purchase Date: ____________________________________________ Save the receipt, warranty, and this manual. It is important that you read the entire manual to become familiar with this product before you begin using it.This air hose reel is designed for certain applications only. Northern Tool & Equipment is not responsible for issues arising from modification or improper use of this product such as an application for which it was not designed. We strongly recommend that this product not be modifiedand/or used for any application other than that for which it was designed. For technical questions, please call 1-800-222-5381.Intended Use (4)Technical Specifications (4)Important Safety Information (4)Specific Operation Warnings (6)Assembly Instructions (7)Before Each Use (7)Operating Instructions (8)Maintenance (8)Troubleshooting (9)Parts Diagram (9)Parts List (9)Replacement Parts (10)Limited Warranty (11)The 3/8in. x 100ft. Floor Stand Air Hose Reel incorporates metal forms to ensure strength and function equally well in both mobile and permanent-mount situations. This hose real is suitable for a variety of heavy-duty applications in the mining, construction, service, and marine industries.1. Prior to mounting the hose reel, ensure that the supply line pressure does not exceed the maximum working pressure of the hose reel.2. Unpack and inspect the reel for damage. Turn the reel by hand to check for smooth and correct operation.3. Place the reel on a completely level floor. It’s ideal if the floor has texture for stability.Floor4. Apply Teflon tape or pipe sealant to the supply line threads. Then attach the line threads to the reel inlet and tighten. The other end of the incoming line can now be connected to the desired supply source.5. Apply Teflon tape or pipe sealant to the outlet fitting on the reel hose and then attach it to the desired tool or nozzle. Check the connection for leakage; also check the hose reel for correct operation.6. If the hose stopper adjustment is required, pull the hose from the reel and allow it to latch at the desired length. Loosen the stopper bolts, and slide the stopper to a position close to the hose guide. Tighten the stopper bolts and unlatch the reel.1. Check the reel for correct and smooth operation by slowly pulling out the hose. A clicking noisewill be heard every half revolution of the drum.2. To latch the reel, pull out the hose and then allow it to retract after hearing the first, second, orthird click.3. To unlatch the reel, slowly pull out the hose until the clicking noise stops. Then, holding on to thehose, let it retract in a controlled way.Maintain the hose reel by adopting a program of conscientious repair and maintenance in accordance with the following recommended procedures. It is recommended that the general condition of any tool be examined before it is used. Keep your tool in good repair. Keep handles dry, clean, and free from oil and grease. The following chart is based on a normal operation schedule.Use the table below to troubleshoot problems before contacting service personnel or your local dealer. If the problem continues after troubleshooting, call your local dealer for assistance.∙For replacement parts and technical questions, please call Customer Service at 1-800-222-5381. ∙Not all product components are available for replacement. The illustrations provided are a convenient reference to the location and position of parts in the assembly sequence.∙When ordering parts, the following information will be required: item description, item model number, item serial number/item lot date code, and the replacement part reference number.∙The distributor reserves the rights to make design changes and improvements to product lines and manuals without notice.Northern Tool and Equipment Company, Inc. ("We'' or "Us'') warrants to the original purchaser only ("You'' or "Your") that the Klutch product purchased will be free from material defects in both materials and workmanship, normal wear and tear excepted, for a period of two years from date of purchase. The foregoing warranty is valid only if the installation and use of the product is strictly in accordance with product instructions. There are no other warranties, express or implied, including the warranty of merchantability or fitness for a particular purpose. If the product does not comply with this limited warranty, Your sole and exclusive remedy is that We will, at our sole option and within a commercially reasonable time, either replace the product or product component without charge to You or refund the purchase price (less shipping). This limited warranty is not transferable.Limitations on the WarrantyThis limited warranty does not cover: (a) normal wear and tear; (b) damage through abuse, neglect, misuse, or as a result of any accident or in any other manner; (c) damage from misapplication, overloading, or improper installation; (d) improper maintenance and repair; and (e) product alteration in any manner by anyone other than Us, with the sole exception of alterations made pursuant to product instructions and in a workmanlike manner.Obligations of PurchaserYou must retain Your product purchase receipt to verify date of purchase and that You are the original purchaser. To make a warranty claim, contact Us at 1-800-222-5381, identify the product by make and model number, and follow the claim instructions that will be provided. The product and the purchase receipt must be provided to Us in order to process Your warranty claim. Any returned product that is replaced or refunded by Us becomes our property. You will be responsible for return shipping costs or costs related to Your return visit to a retail store.Remedy LimitsProduct replacement or a refund of the purchase price is Your sole remedy under this limited warranty or any other warranty related to the product. We shall not be liable for: service or labor charges or damage to Your property incurred in removing or replacing the product; any damages, including, without limitation, damages to tangible personal property or personal injury, related to Your improper use, installation, or maintenance of the product or product component; or any indirect, incidental or consequential damages of any kind for any reason.Assumption of RiskYou acknowledge and agree that any use of the product for any purpose other than the specifieduse(s) stated in the product instructions is at Your own risk.Governing LawThis limited warranty gives You specific legal rights, and You also may have other rights which vary from state to state. Some states do not allow limitations or exclusions on implied warranties or incidental or consequential damages, so the above limitations may not apply to You. This limited warranty is governed by the laws of the State of Minnesota, without regard to rules pertaining to conflicts of law. The state courts located in Dakota County, Minnesota shall have exclusive jurisdiction for any disputes relating to this warranty.Distributed by:Northern Tool & Equipment Company, Inc.Burnsville, Minnesota 55306Made in China。
卡格净列说明书
【药品名称】通用名称：卡格列净片商品名称：卡格列净片(怡可安)英文名称：Canagliflozin Tablets拼音全码：KaGeLieJingPian(YiKeAn)【主要成份】主要成份：卡格列净。
【性状】本品为黄色胶囊形薄膜衣片（100mg规格）或白色至类白色胶囊形薄膜衣片（300mg规格）。
除去包衣后应显白色。
【适应症/功能主治】本品与二甲双胍联用：当单独使用二甲双胍血糖控制不佳时，可与二甲双胍联合使用，配合饮食和运动改善成人2型糖尿病患者的血糖控制。
本品与二甲双胍和磺脲类药物联用：当联用二甲双胍和磺脲类药物血糖控制不佳时，可与二甲双胍和磺脲类药物联合使用，配合饮食和运动改善成人2型糖尿病患者的血糖控制。
本品不建议用于1型糖尿病患者或糖尿病酮症胺中毒（患者）的治疗。
【规格型号】 100mg*10s*1板【用法用量】本品的推荐起始剂量为100mg每天一次，当天第一餐前服用。
对于耐受本品100mg每天一次的剂量、肾小球滤过率估计值(eGFR) ≥60 mL/min/1.73 m2且需要额外血糖控制的患者，剂量可增加至300mg每天一次（参见注意事项、药理毒理）。
对于血容量不足的患者，开始本品治疗前建议纠正这种情况（参见注意事项、老年用药）。
肾损害患者在开始本品治疗前，建议评估肾功能，并在治疗开始后定期进行评估。
轻度肾损害(eGFR≥60 mL/min/1.73 m2)的患者无需调整剂量。
对于中度肾损害（eGFR≥45至<60 mL/min/1.73 m2）的患者，本品的剂量限制为100mg每天一次。
对于eGFR<45mL/min/1.73 m2的患者，不建议使用本品。
当eGFR持续低于45 mL/min/1.73 m2时，不建议使用本品（参见注意事项）。
eGFR低于30 mL/min/1.73 m2的患者禁止使用本品（参见注意事项）。
肝损害患者轻度至中度肝损害患者无需调整剂量。
目前没有在重度肝损害患者中开展I临床研究，故不推荐重度肝损害的患者使用本品。
XELSIS 产品说明书
Cod.10003050-51-52-53-3250-51-52Cod.10003278-79-3314-3450-70-71Cod.10003501-3663-3730-31-32-33SUP038SUP038ZRI9943/11-21-41-43RI9944/01-04-41-43RI9946/01-47345678POS POS CODE CODE DESCRIPTION DESCRIPTIONNOTENOTE12NC 12NC 01 15002162 996530009411 MANUAL V2 SAE SUP038 MYB9/H D/I 15002163 996530009412 MANUAL V2 SAE SUP038 MYB9/H GB/F 15002164 996530009413 MANUAL V2 SAE SUP038 MYB9/H E/P 15002165 996530009414 MANUAL V2 SAE SUP038 MYB9/H NL/PL 15002166 996530066721 MANUAL V2 SAE SUP038 MYB9/H CHN 15001810 996530009297 MANUAL SAE SUP038Z MYB9/T D/I ID 15001811 996530009298 MANUAL SAE SUP038Z MYB9/T GB/F ID 15001812 996530009299 MANUAL SAE SUP038Z MYB9/T E/PID 15001813 996530009301 MANUAL SAE SUP038Z MYB9/T NL/PL ID15002167 996530068484 MANUAL V2 SAE SUP038 MYB9/H BRA GB 15002723 996530068485 MANUAL V2 SAE SUP038 MYB9/H PT/BRA 02 146680850 996530016529 BLACK COFFEE MEASURE SMART 03 127390100 996530011867 BRUSH FOR CLEANING04 11028379 996530070318 PSA KLUBER TRIBOSTAR SIL 2 TUBE 5GR.05 21002051 996530071783 A CC PSA MAVEA WATER FILTER 1UNIT USA-BRA06 0301.961 996530039604 STICKER FOR WATER HARDNESS TEST 07 183911050 996530025808 BLACK POWER CABLE SCHUKO L=1200 183930650 996530025858 POWER CABLE CH BLACK 3X1 H05VV-F L=1200 183921950 996530025843 POWER CABLE SJT3 USA BLACK UL L=1200 183940650 996530025872 BLACK POWER CABLE A USTRALIA L=1200 11001985 996530001089 BLACK POWER CABLE KOREA L=1200 11004246 996530002166 BLACK POWER CABLE TAIWAN HVCTF L=1200 11004247 996530002167 BLACK POWER CABLE RVV 3X1 CHINA L=1200 17800024 996530009632 BLACK POWER CABLE JAPPON VCTF L=1200MM 17800019 996530009627 BLACK POWER CABLE BRAZIL L=1200 220V 17800330 996530069926 BLACK POWER CABLE BRAZIL L=1200 127V08 13001097 996530008404 BAND FOR LIFTING L=1800MM H=300MM 09 20006891 996530067538 KIT PS-E INSERT FOR BOX MYB910 11022804 996530007446 SM/SS FRONT COVER CASING INS.MYB9/T A SSY ID 11 13000920 996530008348 DISPLAY BOX MYB9/H SAE XELSIS SS 13001110 996530008408 DISPLAY BOX MYB9/H SAE XELSIS CLASS 13001112 996530008411 DISPLAY BOX MYB9/T SAE XELSIS ID SS ID12 12000450 996530007819 SCREW TCBR TORX 10 3,5X12 PLAST.ZN-N 13 11013210996530006691 SB/SS G ROUND C ONT .DOOR C OVER S /S.MYB9 A S UP TO S/N. TU90122710414011025978996530072657 SB/SS G ROUND C ONT .DOOR C OVER S /S.MYB9 A S FROM S/N TU90122710414111023203996530007597 SM/SS G ROUND C ONT .DOOR C OVER S /S.MYB9 A S ID14 11013148996530006653 SB/SS W A TER C ONT AIN.DOOR C OVER M YB9 A SSYUP TO S/N. TU90122710414011029403996530072665 SB/SS W A TER C ONT .DOOR C OVER V 2 M YB9 A SSYFROM S/N TU90122710414111029406 996530072983 BLACK W A TER C ONT .DOOR C OVER V 2 M YB9 A SSY 11029404 996530072937 WHITE W A TER C ONT .DOOR C OVER V 2 M YB9 A SSY11023196 996530007595 SM/SS W A TER C ONT AIN.DOOR C OVER M YB9 A SSY ID 15 17000101996530070341 SB/SS LEFT SIDE PANEL V2 MYB9/H-T A SSY .UP TO S/N. TU90122710414011028790996530072664 SB/SS LEFT SIDE PANEL V2 MYB9/H-T A SSY .FROM S/N TU90122710414111024524 996530070337 BLACK LEFT SIDE PANEL V2 MYB9/H-T A SSY .11024523 996530070334 WHITE LEFT SIDE PANEL V2 MYB9/H-T A SSY . 11024522 996530070338 SM/SS LEFT SIDE PANEL V2 MYB9/H-T A SSY . ID16 11022426 996530007365 SS S PRING F OR W A TER C ONT AINER L EVER M YB917 12001263 996530008019 BLACK PUSH-PUSH MYB918 11022425 996530007364 YELLOW L EVER F OR W A TER C ONT AIN.S/SC.MYB919 11012859996530006558 SB/SS CUP WARMING LID MYB9UP TO S/N. 9010SA4002675817000071996530066728 SB/SS CUP WARMING LID MYB9 A SSY .FROM S /N.9010SA40026759 T O S /N. 9010SA40120165 17000059996530067839 SB/SS CUP WARMING LID V2 MYB9FROM S /N 9010SA40120165 T O S /N. T U901227104140 11025965996530072656 SB/SS CUP WARMING LID V2 MYB9FROM S/N TU90122710414120007063996530071497 KIT B LK C UP W ARMING+CASING C OVER V 2 M YB9 IDUP TO S/N 9010SA4012016511024245996530070333 SM/SS CUP WARMING LID V2 MYB9IDFROM S/N 9010SA401201662011013149996530006654 SB/SS B EAN C ONTAIN.DOOR C OVER M YB9 A SSY .UP TO S/N. TU90122710414011029385996530072661 SB/SS BEAN CONT .DOOR COVER V2 MYB9 A SSY .FROM S/N TU90122710414111029388 996530072981 BLACK B EAN C ONT .DOOR C OVER V 2 M YB9 A SSY . 11029386 996530072982 WHITE B EAN C ONT .DOOR C OVER V 2 M YB9 A SSY . 11023198 996530007596 SM/SS B EAN C ONTAIN.DOOR C OVER M YB9 A SSY . ID 2112001330996530008026TRANSP .ROUND A DHESIVE FOOT SJ-5382Cod.10003050-51-52-53-3250-51-52Cod.10003278-79-3314-3450-70-71Cod.10003501-3663-3730-31-32-33SUP038SUP038ZRI9943/11-21-41-43RI9944/01-04-41-43RI9946/01-47345678POS POSCODE CODEDESCRIPTIONDESCRIPTIONNOTENOTE 12NC 12NC22 11022809996530007452 SB/SS R EAR C OVER C ASING I NSERT M YB9 A SSY UP TO S/N. TU901227104140 11025964996530072663 SB/SS R EAR C OVER C ASING I NSERT M YB9 A SSYFROM S/N TU90122710414111022821 996530007454 BLK REAR COVER CASING INSERT MYB9 A SSY . 11022820 996530007453 WHT REAR COVER CASING INSERT MYB9 A SSY . 11023105 996530007582 SM/SS R EAR C OVER C ASING I NSERT M YB9 A SSY ID23 17000205 996530066735 BLACK C OVER C ASING W /PROTECT .V2 M YB9/H-T 24 11003232 996530001522 A S.CPU+SW WATER LEVEL SENSOR V2 25 11014017 996530006969 BLACK H ORIZONT AL M OUNTING P LA TE M YB9 A SS 26 11024263 996530067506 PWR BOARD MDS 230V230V 11021342 996530007079 PWR BOARD MYB9/MDS 120V120V27 11012035 996530006299 BLACK PWR BOARD COVER MYB928 17000123 996530067922 BLACK R EAR P ANEL W HIT L OGO S AECO V 2 M YB929 11023304 996530007613 PWR ELECTR.BOARD INSULATE SHEET MYB9 ONLY 120V 30 17000102996530070339 SB/SS RIGHT SIDE PANEL V2 MYB9/H-T A SSY . UP TO S/N. TU90122710414011028791996530072662 SB/SS RIGHT SIDE PANEL V2 MYB9/H-T A SSY . FROM S/N TU90122710414111024520 996530070336 BLACK RIGHT SIDE PANEL V2 MYB9/H-T A SSY . 11024509 996530070335 WHITE RIGHT SIDE PANEL V2 MYB9/H-T A SSY . 11024508 996530070231 SM/SS RIGHT SIDE PANEL V2 MYB9/H-T A SSY . ID31 11022805996530007447 SB/SS FRONT COVER CASING INS.MYB9/H-P A S UP TO S/N. TU90122710414011025962996530072659 SB/SS FRONT COVER CASING INS.MYB9/H-P A S FROM S/N TU90122710414111022807 996530007449 BLK FRONT COVER CASING INS.MYB9/H-P A SSY 11022806 996530007448 WHT FRONT COVER CASING INS.MYB9/H-P A SSY 32 11013170 996530006676 BLACK STEEL CASING MYB9 A SSY .33 11021769 996530007136 BLACK RIGID FOOT FIXING PIN MYB934 11021829 996530007156 BLACK/TRANSP .RIGID FOOT MYB935 11022527 996530007397 BLACK DUMP BOX PROTECTION MYB936 11013595 996530006815 BLACK DUMP BOX MYB9 A SSY .37 11022169 996530007247 BLK DRIP TRAY COFF.BREW UNIT COVER MYB938 17001901 996530071992 BLACK COFFEE UNIT DRIP TRAY V2 MYB939 11013128 996530006642 40POLES FLAT CABLE BOARDS LINK MYB9 UL 4011013806996530006864 BLACK FLAT-CABLE PROTECTION MYB941 W GA 4316031000 996530063553 A DHESIVE HEATING-ELEMENT 230V 230V 11000791 996530000503 A DHESIVE HEATING-ELEMENT 120V100V-120V42 11008844 996530005056 2POLES C ONNECT .SUPPL Y C UPWARMING G 0053UL43 17000007 996530066726 COMPONENTS SUPPORT INSULATE SHEET MYB9 ONLY 120V 44 13001231 996530008429 PS-E INSERT FOR BOX MYB945 17000420 996530067881 BLACK SLIM BOILER PROTECTION MYB9 WITH B OILER S LIM4612001728996530070321 SCREW TCBR TORX 10 3,5X12 PLAST.SSCod.10003050-51-52-53-3250-51-52Cod.10003278-79-3314-3450-70-71Cod.10003501-3663-3730-31-32-33SUP038SUP038ZRI9943/11-21-41-43RI9944/01-04-41-43RI9946/01-47POS POS CODE CODE DESCRIPTIONDESCRIPTIONNOTENOTE12NC 12NC 01 11022728996530007422 SB/SS FRONTAL PANEL MYB9 A SSY .UP TO S/N.9009SA4029891611023318996530007614 SB/SS FRONT PANEL V2 MYB9 A SSY .FROM S /N.9009SA40298917 T O S /N. T U901227104140 11025938996530072976 SB/SS FRONT PANEL V2 N/S/SCR.MYB9 A SSY .FROM S/N TU90122710414111013277996530006719 BLACK FRONT PANEL N/S/SCREEN MYB9 A SSY .UP TO S/N.9009SA4029891611023522996530007634 BLK FRONTAL PANEL V2 S/SCREEN MYB9 A SSY .FROM S/N.9009SA4029891711013298996530006732 WHITE FRONT PANEL N/S/SCREEN MYB9 A SSY .UP TO S/N.9009SA4029891611023523996530007635 WHT FRONTAL PANEL V2 S/SCREEN MYB9 A SSY .FROM S/N.9009SA4029891711023319 996530007615 SM/SS FRONTAL PANEL V2 MYB9 A SSY . ID02 11011406 996530006054 ADHES.SILVER PLATE LOGO SAECO P005703 11022725 996530007418 ADHES.SILVER PLATE LOGO XELSIS04 11021449996530007103 CHROM.CONNECT .CAP F OR C ARAFE M YB9 A SSY .UP TO S/N.9009SA4029891611024247996530066715 CHROM.CONNEC.CAP F OR C ARAFE V 2 M YB9 A SSYFROM S/N.9009SA4029891705 12001369 996530008039 SCREW TSP TORX 10 5X35 PLAST.SS06 17000215 996530070073 BLACK DRIP T RAY SUPPORT V2 MYB9/H-P A SSY 17000223 996530070223 BLACK DRIP TRAY SUPPORT V2 MYB9/T A SSY .07 11013143996530006649 CHROM.ZAMA FRONT FRAME MYB9UP TO S/N.9009SA4029891608 11001624 996530000929 BLACK STEAM TUBE WASHER P004909 NF11.084996530059199 PHOSPH/STEEL FOLK SPRINGUP TO S/N.9010SA4003648010 9011.144 996530048885 SS FORK FOR TUBE D=411 140328059996530013564 OR 2015 SILICONE PTFE/FDAUP TO S/N.9009SA4029891612 11013244 996530006708 TF/CHROM.- CHROM.STEAM TUBE MYB9 A SSY .13 11013215 996530006694 DOOR UPPER HINGE MYB914 11022860996530007469 BLACK CONNECTOR V2 FOR CARAFE MYB9UP TO S/N.9009SA402989161512001430996530008051SCREW TCBR TORX 20 4X10 PLAST.SS16 129573221 996530012922 SCREW TCB PH/TT 4X8 UNI 8112 SS17 11022870996530007476 STEEL S PRING F OR C ARAFE C ONNECTOR M YB9UP TO S/N.9009SA4029891618 11022853996530007466 BRASS I NSERT F OR S PRING C ARAFE C ONN.MYB9UP TO S/N.9009SA4029891619 12000450 996530007819 SCREW TCBR TORX 10 3,5X12 PLAST.ZN-N 20 11014015996530006967 BLK C ARAFFE B OARD S UPPORT G EN.MYB9 A SSY .UP TO S/N.9009SA4029891621 12001431 996530008052 SCREW TCB TORX 10 3X12 PLAST.SS22 11013784 996530006855 BLACK TEFLON TUBES SUPPORT COVER MYB923 11013785 996530006856 STEEL T EFLON T UBES SUPPORT SPRING MYB924 11021692996530007111 PREFORMED T EFLON T UBES S UPPORT M YB9 A SSYUP TO S/N.9009SA4029891625 11013216 996530006695 DOOR LOWER HINGE MYB926 20006820 996530010248 KIT SPARES FRONT PLATE DISPLAY MYB9/H-T 27 12001261 996530008018 DISPLAY 320x240 N O T OUCH B RIGHTNESS+MYB928 11013226 996530006702 BLACK DISPLAY SEAL MYB9/H-T 29 11012889 996530006568 BLACK DISPLAY SUPPORT MYB9/H-T 30 129913202 996530013156 SCREW TCB TORX 10 3X8 PLAST.ZN-B 31 149450588 996530018311 65SH SILICONE BOILER SEALING VALVE 32 11012377996530006381 BLACK CPU BOARD COVER MYB9/H-TUP TO S/N.9009SA4029891617000014996530009564 BLACK CPU BOARD COVER V2 MYB9/H-TFROM S/N.9009SA4029891733 11014215 996530007042 BLACK BUTTON FOR DOOR RELEASE MYB934 11021976 996530007207 STEEL PLATE FOR DOOR CLOSURE MYB935 11024441996530067552 CPU+SW MYB9/H PSA A SSY .UP TO S/N TU901150186483 11026862996530070332 CPU+SW MYB9/H SLIM A SSY .FROM S/N TU901150186484 11024443996530067563 CPU+SW MYB9/T PSA A SSY .IDUP TO S/N TU901150186483 11026860996530070331 CPU+SW MYB9/T SLIM A SSY . IDFROM S/N TU90115018648436 11000651 996530000425 WATER LEVEL SENSOR BOARD P1243711001339996530000763TRANSP .INFRAREDS PLATE P0049Cod.10003050-51-52-53-3250-51-52Cod.10003278-79-3314-3450-70-71Cod.10003501-3663-3730-31-32-33SUP038SUP038ZRI9943/11-21-41-43RI9944/01-04-41-43RI9946/01-47POS POS CODE CODE DESCRIPTIONDESCRIPTIONNOTENOTE12NC 12NC 38 11022583996530007412 BLK I NSIDE C OVER F RON.PANEL S /SCR.MYB9/HUP TO S/N.9009SA4029891617000021996530009568 BLK I NSIDE C OVER F RON.PANEL V 2 S /S.MYB9HFROM S/N.9009SA4029891739 129912521 996530013148 SCREW TCBR TORX 10 3,5X14 PLAST.SS 40 11014218 996530007043 BLACK C OVER B UTTON F OR D OOR R ELEASE M YB941 11021747 996530007128 SPRING FOR DOOR RELEASE BUTTON MYB942 128310402 996530012341 GALV.WASHER UNI 8842 A 443 11023393996530007625 CHROM.ZAMA FRONT FRAME V2 MYB9FROM S/N.9009SA4029891744 17000006996530009559 TWO W A Y T EFLON T UBES S UPPORT S PRING M YB9FROM S/N.9009SA4029891745 11023352996530066675 WHT P REFORM.TEFLON T UBES S UPP .MYB9 A SSY .FROM S/N.9009SA4029891746 11023251996530007606 BLACK FRONTAL PANEL INSERT MYB9FROM S/N.9009SA4029891747 11023423996530066676 BLK C ARAFFE B OARD S UPP .GEN.V2 M YB9 A SSY .FROM S/N.9009SA4029891748 12001330 996530008026 TRANSP .ROUND A DHESIVE FOOT SJ-538249 17000055996530072431 GALVAN/STEEL FOLK SPRING W/FASTONFROM S/N. 9010SA4003648150 11006740996530003793 BRONZE SPRING FOR FRONT CASING G0053FROM S/N. 9010SA4003648151 17001306996530070328 BLACK FINGER PRINT COVER V2 MYB9/T ID52PARTICULAR NOT A VAILABLEID (SEE P ART .N°59)53 17000074 996530066729 BLK L OWER F INGERPRINT S ENS.SEAL V2 M YB9/T ID 54 11013309 996530006739 BLACK FINGER PRINT SUPPORT MYB9/T 55 129913702 996530013162 SCREW TCB TORX10 2,5X8 PLAST.ZN-B 56 17001078996530070329 BLACK V 3 F INGERPRINT S ENSOR S EAL M YB9/T ID57PARTICULAR NOT A VAILABLEID (SEE P ART .N°59)58 17000022 996530009569 BLK I NSIDE C OVER F RON.PANEL V 2 S /S.MYB9T ID 59 20006871996530066745 KIT SPARES FINGERPRINT SENSOR MYB9/T IDWITH PART . N°31-51-52-53-54-55-56-5760 11023238 996530007602 AS.SUPP .SCHEDA CARAF.V4 MYB9 NER.61 11013368 996530006754 MILKCARAFFE BOARD V2 MYB962 17000002 996530009555 BLACK CARAFE MICRO INSERT V2 MYB96317000019996530009566SS CARAFE MICRO INSERT SPRING MYB964 11013328 996530006745 BLACK CARAFFE BOARD COVER MYB965 17000045 996530009578 BLK P RESENCE C ARAFE M ICRO I NSERT V 2 M YB966 12000895 996530007951 SCREW TSP TORX 10 3X10 PLAST.SS67110131279965300066412POLES C ONNECT .SENSOR R EED D OOR M YB9 U LCod.10003050-51-52-53-3250-51-52Cod.10003278-79-3314-3450-70-71Cod.10003501-3663-3730-31-32-33SUP038SUP038ZRI9943/11-21-41-43RI9944/01-04-41-43RI9946/01-4721POS POSCODE CODEDESCRIPTIONDESCRIPTIONNOTENOTE12NC 12NC01 11027228996530070234 CHROM.COFFEE DISPENSER V2 MYB9 A SSY . WITH PART . N° 02 - 03 - 04 - 05 - 06 - 0702 129570721 996530012907 SCREW TCB TORX 10 M3X8 A UTOFORMING SS 03 11013001 996530006579 BLACK REAR COVER COFFEE DISPENSER MYB904 11013003 996530006582 BLACK COFFEE DISPENSER INNER BODY MYB905 11013085 996530006614 WHITE COFFEE DISPENSER SLIDER MYB906 11013002 996530006581 BLACK C OF .DISPENSER E XT .MOBILE P ART M YB907 11013222996530006699 CHROM.FRONT C OFFEE D ISPENSER C OVER M YB9 UP TO S/N TU90112107104011027227996530070327 CHROM.FRONT C OFF .DISPENSER C OVER V 2 M YB9 FROM S/N TU90112107104108 11022128 996530007237 C HROM.CREAM A DJUSTMENT K NOB S /SCR.MYB909 126772518 996530011711 SS COFF .CREAM A DJUSTMENT SHAFT SPRING 10 11013324 996530006743 BLACK CREAM A DJUSTMENT KNOB RING MYB911 140326661 996530013546 OR ORM 0040-20 BLACK EPDM12 140640200 996530013621 WHITE COFFEE CREAM A DJUSTMENT SHAFT 13 11013323 996530006742 CHROM.COFFEE DISPENSER SUPPORT MYB914 12000897 996530007953 SCREW TCB TORX 10 3,5X20 PLAST.SS 15 11013072 996530006604 BLACK SEAL FOR COFFEE DISPENSER MYB916 11013013 996530006585 BLACK COFFEE DISPENSER TUBE MYB917 12000070 996530007732 OR ORM 0060-15 SILICONE18 12000450 996530007819 SCREW TCBR TORX 10 3,5X12 PLAST.ZN-N 19 149360200 996530018269 SILICONE TUBE 5X8 70SR IN ROLL20 11013364 996530006752 BLACK DISPENSER COFF .INLET CONNECT .MYB92111012926996530006575 BLACK COFFEE DISPENSER CONNECTOR MYB9Cod.10003050-51-52-53-3250-51-52Cod.10003278-79-3314-3450-70-71Cod.10003501-3663-3730-31-32-33SUP038SUP038ZRI9943/11-21-41-43RI9944/01-04-41-43RI9946/01-47POS POS CODE CODE DESCRIPTIONDESCRIPTIONNOTENOTE12NC 12NC 01 11013212 996530006692 NAT/GREY WATER CONTAINER MYB9 A SSY .02 11012738 996530006509 BLACK HANDLE WATER CONTAINER LID MYB903 140328461 996530013571 OR ORM 0190-10 EPDM04 224640200 996530029115 WHITE WATER CONTAINER EXT.FILTER A SSY .05 140324362 996530013507 OR ORM 0060-30 SILICONE06 126764718 996530011626 SS WATER CONTAINER VALVE SPRING 07 147660562 996530016894 GREY PISTON FOR WATER CONTAINER VALVE 0811012736996530006507NAT/GREY WATER CONTAINER LID MYB909 0701.031.150 996530044417 GREY WATER VALVE GACO DIM 14 SEAL COVER 10145842900996530015823NBR WATER CONT.VALVE GACO DIM14 SEAL 11 0701.014.150 996530044404 GREY WATER VALVE GACO DIM 14 SEAL CONT .12 140320461 996530013446 OR ORM 0080-20 TERMOIL13 129535721 996530012898 SCREW TSP TORX 10 A B 3,5X9,5 SHEET SS 14 20006842996530066742 SPARES KIT BEAN COFFEE CONT .LID V2 MYB9UP TO S/N.9010SA4012016517000202996530066734 NAT/GREY BEAN COFF .CONT .LID V2 MYB9 A SSYFROM S/N.9010SA4012016615 149213059 996530018116 GREY CAP FOR KNOBS BEAN CONTAINER 16 129913902 996530013164 SCREW TCB TORX 10 3X12 PLAST.ZN-B 17 20006843996530066743 SPARES K IT B EAN C OFFEE C ONTAINER V 2 M YB9UP TO S/N.9010SA4012016517000194996530066733 BLACK BEAN CONTAINER V2 MYB9FROM S/N.9010SA4012016618 11012852 996530006551 BLACK GRIND.ADJUSTMENT KNOB MBY919 11022528 996530007398 GREY G RIND.ADJUSTMENT K NOB W ASHER M YB920 145897300 996530016123 BLK I NSERT G RIND.ADJUSTMENT K NOB S MART121 11022803 996530007445 SS DRIP TRAY GRATE V2 MYB9/H-P 11022385 996530007345 SS DRIP TRAY GRATE MYB9/TID22 17000147 996530066732 BLACK GRATE SEAL V3 MYB9/H-P 23 11022802 996530007444 BLACK DRIP TRAY COVER V2 MYB9/H-P 11022384 996530007344 BLACK DRIP TRAY COVER MYB9/TID24 11005388 996530002866 RED FLOAT FOR DRIP TRAY P124 17000001 996530009554 RED FLOAT FOR DRIP TRAY MDSID25 17800061 996530066741 5POLES C ONNECTOR M C S ENSORS V 2 M YB9 U L 26 11013214996530006693 SB/SS-BLACK DRIP TRAY MYB9/H-P A SSY .UP TO S/N. TU90122710414026 11025971996530072666 SB/SS-BLACK DRIP TRAY MYB9/H-P A SSY .FROM S/N TU90122710414111013281 996530006723 BLACK/BLACK DRIP TRAY MYB9/H-P A SSY . 11013300 996530006734 WHITE/BLACK DRIP TRAY MYB9/H-P A SSY .11022389996530007348SM/SS-BLACK DRIP TRAY MYB9/T A SSY .IDCod.10003050-51-52-53-3250-51-52Cod.10003278-79-3314-3450-70-71Cod.10003501-3663-3730-31-32-33SUP038SUP038ZRI9943/11-21-41-43RI9944/01-04-41-43RI9946/01-47POS POSCODE CODEDESCRIPTIONDESCRIPTIONNOTENOTE12NC 12NC01 11012845996530006545 TRANSP/CHROM.GEN.CARAFE M YB9 S AE A SSY .UP TO S/N.9009SA4029891602 11021984996530007208 CHROM.CARAFE C APP .COVER S /SC.MYB9 A SSY .UP TO S/N.9009SA4029891603 11022498 996530007389 CHR.CARAFE U PPER D ISPEN.SUPP .V2 S /S.MYB904 11012812 996530006527 VENTURI TUBE FOR CAPPUCCINATORE MYB905 11012678 996530006463 BLACK CARAFE MILK DISPENSER TUBE MYB906 11013163 996530006668 BLACK UPPER TUBE CARAFE CONNECT .MYB907 11022496 996530007388 CHRO.CARAFE L OWER D ISPENSER S UPP .V2 M YB908 11012816 996530006531 BLACK UPPER COVER PART CARAFE MYB909 12000550 996530007838 SCREW TCB TORX 10 3X25 PLAST.SS 10 11021893 996530007192 BLACK L OWER C OVER P ART C ARAFE M YB9 A SSY .11 11013466 996530006784 CHROM.CARAFE REAR PART HANDLE MYB912 11023158 996530007588 CHROM.CARAFE F RONT P ART H ANDLE V 2 M YB913 149360200 996530018269 SILICONE TUBE 5X8 70SRIN ROLL14 129911721 996530013137 SCREW TSP TORX 4X16 PLAST STEEL 15 11013164 996530006669 BLACK LOWER TUBE CARAFE CONNECT .MYB916 129910921 996530013128 SCREW TCB TORX 10 3X10 SS 17 9161.111 996530050555 MAGNET FOR FLOAT SUPERAUT.18 11014016 996530006968 SS.INSERT FOR MAGNET MYB919 12000895 996530007951 SCREW TSP TORX 10 3X10 PLAST.SS 20 11024104 996530007705 TRANSP .CARAFE V3 S/SCREEN MYB921 11012677996530006462 BLACK C ARAFE C APPUCCINA TORE C ASING M YB9UP TO S/N.9009SA4029891622 11026779 996530067887 WHITE MILK TUBE CONNECTOR V2 MYB923 11012814 996530067584 SILICONE TUBE 3,5X6 L=140 MM24 11013765 996530006849 STEEL SPRING FOR CARAFE LEVER MYB925 11022522 996530007393 BLACK CAM FOR CARAFE LEVERS V2 MYB926 11013832 996530006873 CARAFE SPRING WITH INSERT MYB9 A SSY .27 17000131 996530067459 BLACK LEVER FOR CARAFE CAM V3 MYB928 17000004996530009557 BLK C ARAFE C APPUCCIN.CASING W /CAPS M YB9FROM S/N.9009SA4029891729 11023235996530007599 CHR.CARAFE C APP .COVER V 2 S /SC.MYB9 A SSY .FROM S/N.9009SA4029891730 11023236996530007601 TRANSP/CHROM.GEN.CARAFE V 3 M YB9 S AE A SSYFROM S/N.9009SA4029891711023077996530067527TRANSP/CHROM.GEN.CARAFE M YB9/MDS A SSY . ONLY BRASILCod.10003050-51-52-53-3250-51-52Cod.10003278-79-3314-3450-70-71Cod.10003501-3663-3730-31-32-33SUP038SUP038ZRI9943/11-21-41-43RI9944/01-04-41-43RI9946/01-47POS POS CODE CODE DESCRIPTIONDESCRIPTIONNOTENOTE 12NC 12NC 01 11012205 996530006316 BLACK COMPONENTS SUPPORT MYB902 11012412 996530006399 BLACK SOCKET-SWITCH SUPPORT MYB9 11023406 996530007626 BLACK SOCKET-SWITCH SUPPORT MYB9 UL 03 12001645 996530069782 CUP SOCKET V2 EN 60320 C 1304 NE03.038 996530058836 BIPOLAR SWITCH FUSIT C1250AR05 12000450 996530007819 SCREW TCBR TORX 10 3,5X12 PLAST.ZN-N 06 12001212 996530008003 ULKA PUMP MF 230V-50HZ 230V-50HZ 12001346 996530008028 ULKA PUMP MF 120V-60HZ 120V-60HZ 12001348 996530008031 ULKA PUMP MF 220V-50/60HZ 220V-50/60HZ 12001347 996530008029 ULKA PUMP MF 100V-50/60HZ100V-50/60HZ07 11012194 996530006315 BLACK/SBR ULKA MF PUMP SUPPORT 08 11013116 996530006631 2POLES CONNECTOR STEAM PUMP MYB9 UL 09 11012193 996530006314 90° INLET CONNECTOR FOR PUMP ULKA MF 10 147920300 996530017351 TRANS.CONNECTOR D=8 A RT .80.26.047 KA.46111 JS01.022 996530057357 SILICONE TUBE 5X10 60SH IN ROLL IN ROLL 12 147920150 996530017348 90° INLET PUMP CONNECTOR 13 12000140 996530007753 ULKA PUMP EP5/S GW 230V-50HZ 230V-50HZ 12000142 996530007754 ULKA PUMP EAP5/S 120V-60HZ 120V-60HZ 12000182 996530007782 ULKA PUMP EP5/S GW 220V-60HZ220V-60HZ 12000130 996530007749 ULKA PUMP EP5/S GW 100V-50/60HZ 100V-50/60HZ14 11013076 996530006607 2POLES CONNECTOR COFFEE PUMP MYB9 UL 15 11022857 996530007468 BLACK PUMP SUPPORT GMYB 16 140321961 996530013471 O-RING 2031 TERMOIL17 11001054 996530000624 BLK PUMP OUTLET 90°CONNECTOR P0049/B 18 12000781 996530007887 TURBINE D=1,2 932-8521/90 A SSY .19 11013122 996530006635 6POLES CONNECTOR FLOWMETER MYB9 UL 20 11011341 996530006025 V4 TUB.BOILER 1300W 230V A SSY . 230V-1300W 11011342 996530006026 V4 TUB.BOILER 1300W 120V A SSY . 120V-1300W 11011346 996530006031 V4 TUB.BOILER 1100W 100V A SSY .100V -1100W21 11007907996530004626 TUB.BOILER V5 SIDE THERMOS.FIXING SPRINGUP TO S/N.9009SA4026565711010164996530005641 TUB.BOILER V6 SIDE THERMOS.FIXING SPRINGFROM S/N.9009SA4026565822 12001715 996530069758 SCREW T CB T ORX 20 M 4X8 A UTOFORMING Z N-B 23 190800100 996530026997 TEMPERATURE SENSOR NTC UL L=280MM 24 189428600996530026958 THERMOSTAT 175° 1NT-08L-5125UP TO S/N.9009SA40265657 12001034996530007974 THERMOSTAT ONE SHOT 175°FROM S/N.9009SA402656582512000892996530007947OETIKER CLAMP D=9,5 1670000426 16000380 996530009505 5X8,9 SILICONE TUBE IN ROLLIN ROLL27 11013034 996530006589 STEEL TUB.BOILER SUPPORT MYB928 11012214 996530006322 BLACK TUB.BOILERS SUPPORT MYB929 12001280 996530008024 SCREW TSP TORX 10 5X20 PLAST.ZN-B 30 20006558 996530010201 BLOWDOWN VALVE CASING MYB9 A SSY .31129914302 996530013168 SCREW TORX M4X10 TESTA D=8X1,5 GALV 32 11022428 996530007366 BLK COF .BOILER INSULATING COVER MYB9/H-T 33 184320200 996530025907 SPRING HOSE CLAMP D=9,5MM34 11012206 996530006317 BLACK BLOWDOWN VALVE SUPPORT MYB935 129913902 996530013164 SCREW TCB TORX 10 3X12 PLAST.ZN-B 36 11013711 996530006834 BLACK VALVE FIXING FLANGE MYB937 11013165 996530006671 DIFFUSER VALVE MYB9 A SSY .38 11013528 996530006802 BLACK DIFFUSER PROTECT .VALVE MYB9 A SSY .3911021841 996530007157 SOLENOID VALVE CONNECT .INSUL.PLATE MYB940 11021842 996530007158 SOLENOID V AL VE C ONNECT .INSUL.WASHER M YB94120000590 996530009859 BLOWDOWN VALVE COIL P0049 230V A SSY . 230V 20000680 996530009874 BLOWDOWN VALVE COIL P0049 120V A SSY . 120V 20000920 996530009914 BLOWDOWN VALVE COIL P0049 220V-60HZ A SSY 220V-60HZ20000681 996530009875 BLOWDOWN VALVE COIL P0049 100V A SSY . 100V42 11007565 996530004421 BLACK B LOWDOWN V AL VE C ONNECTOR V 2 P 004943 11005096 996530002744 SS F ORK S PRING F OR B LOWDOWN V ALVE P 004944 12000620 996530007856 OR ORM 0130-20 EPDM45 11021450 996530007104 TUB.BOILER STD C1 INSULATING46 144650300 996530015428 ASPIRATION FILTER GAUZE NET 500 (NEW)11006995996530003974 BLOWDOWN VALVE V2 MYB9 230V A SSY . 230VWITH PART . N°30-41-42-43-4411022038996530007215 BLOWDOWN VALVE V2 MYB9 120V A SSY . 120VWITH PART . N°30-41-42-43-4411021989996530007212 BLOWDOWN VALVE V2 MYB9 220V-60HZ A SSY . 220V-60HZWITH PART . N°30-41-42-43-4411022037996530066669 BLOWDOWN VALVE V2 MYB9 100V A SSY . 100VWITH PART . N°30-41-42-43-4411009776996530005509 TUB.BOILER STD C1 1300W 230V A SSY .WITH PART . N°20-21-22-23-2411009778996530005511 TUB.BOILER STD C1 1300W 120V A SSY .WITH PART . N°20-21-22-23-2411012032996530066667 TUB.BOILER STD C1 1100W 100V A SSWITH PART . N°20-21-22-23-24Cod.10003050-51-52-53-3250-51-52Cod.10003278-79-3314-3450-70-71Cod.10003501-3663-3730-31-32-33SUP038SUP038ZRI9943/11-21-41-43RI9944/01-04-41-43RI9946/01-47916171810POS POSCODE CODEDESCRIPTIONDESCRIPTIONNOTENOTE12NC 12NC01 11011205 996530005991 TEA ZAMA INCREASE SCREW GRINDER 02 149198250 996530017951 BLK U PPER C OFFEEGRINDER G RINDER S UPPORT 03 140328960 996530013577 OR ORM 0530-15 NBR FDA 04 146520100 996530016342 BAKED CLAY GRINDER 48X2805 149198350 996530017952 BLK L OWER C OFFEEGRINDER G RINDER S UPPORT 06 123030300 996530011183 A XIAL BEARING EKKO 342.3525207 140360500 996530013597 FELT RING 45,4X39,4X408 12000450 996530007819 SCREW TCBR TORX 10 3,5X12 PLAST.ZN-N 09 11026355 996530068049 BLK G ROUND C OFF .OUTLET C ONVEYOR V 4 A SSY .10 11030459 996530072511 GRY G ROUND C OFFEE C ONT .LOWER S EAL S MART111 11012856 996530006555 COFFEE G RINDER S OUNDPROOFING C OVER M YB912 226000300 996530029609 GEAR SX Z=38 FOR GRINDER MOTION A SSY .13 149214800 996530018139 MC V 3 M OD=1,25 W ORM S CREW C ENTRING C AP 14 129661702 996530012992 SCREW TCB TORX 3,5X30 PLAST.ZN-B 15 128381902 996530012375 STEEL FLAT WASHER DI=4,3 DE=14 SP=1,516 129574802 996530012928 SCREW TCB TORX 20 M4X30 ZN-B17 11000597 996530000376 COFFEE GRINDER SUPPORT SPRING P12418 128310402 996530012341 GALV.WASHER UNI 8842 A 419 11002873 996530001389 INSULATOR BUSH FOR GRINDER MOTOR P12420 149199050 996530017963 BLK S ENSOR S UPPORT F OR C OF .GRINDER M OTOR 11000513 996530000317 MOTOR COFFEEGRINDER V3.1 230V A SSY . 230V 11000511 996530000315 MOTOR COFFEEGRINDER V3.1 120V A SSY . 120V 11000512 996530000316 MOTOR COFFEEGRINDER V3.1 100V A SSY . 100V22 11013079 996530006611 2POLES C ONNECTOR G RINDER M OTOR M YB9 U L 23 11000194 996530000115 BLACK C OFFEEGRINDER M OTOR S UPPORT P 12424 181540900 996530022784 ELECTR.BOARD WITH SENSOR HAL506 SF-K 25 123030200 996530011182 RADIAL BEARING 61900.2RS126 128381800 996530012374 STEEL CRINKLE WASHER 21,8X14X0,2527 142905450 996530015258 BLK U PPER B ODY W ITH C OFFEE G ROUND O UTLET 28 149199850 996530017976 LOWER G EAR S UPPORT C OFFEEGRINDER S MART 29 126772918 996530011715 SPRING FOR A DJUSTMENT GRINDING GEAR 30 146002150 996530016264 COFFEE GRINDING A DJUSTMENT GEAR SMART 31 149199750 996530017975 UPPER G EAR S UPPORT C OFFEEGRINDER S MART 32 129914002 996530013165 SCREW TCB TORX 10 3,5X16 PLAST.ZN-B 33 17001921 996530072477 BLK WIRING FIX INSERT FOR GRINDER BOARD 11013147 996530006652 GEN.MOTOR C OFFEE G RINDER M YB9 230V A SSY . 230V 11022036 996530007214 GEN.MOTOR C OFFEE G RINDER M YB9 120V A SSY . 120V11022035996530066668 GENERAL MOTOR MC MYB9 100V A SSY .100V。
整理卡格净列说明书_附件
附件192个药物临床试验数据自查核查注册申请清单附件1食品中二甲双胍等非食品用化学物质的测定BJS 201901•范围本标准规定了食品（含特殊食品）中二甲双胍、苯乙双胍、丁二胍、伏格列波糖、阿卡波糖、维达列汀、罗格列酮、西他列汀、吡格列酮、氯磺丙脲、达格列净、格列吡嗪、甲苯磺丁脲、醋磺己脲、妥拉磺脲、瑞格列奈、卡格列净、格列齐特、格列波脲、格列本脲、那格列奈、格列美脲、曲格列酮、格列喹酮、莫格他唑、GW501516、环格列酮等27种非食品用化学物质的高效液相色谱-串联质谱测定方法。
本标准适用于茶叶、奶粉、饼干、酒、饮料等食品（包括上述类似基质的片剂、胶囊剂等形式的特殊食品）中二甲双胍等27种非食品用化学物质的测定。
•原理试样粉碎后经甲醇超声提取，过滤后，上清液供高效液相色谱-串联质谱测定，外标法定量。
•试剂和材料除另有规定，本方法所用试剂均为分析纯或以上规格，水为GB/T 6682规定的一级水。
3.1 试剂3.1.1 乙腈（CH3CN）：色谱纯。
3.1.2 甲酸（HCOOH）：色谱纯。
3.1.3 甲酸铵（HCOONH4）：色谱纯。
3.1.4 甲醇（CH3OH）：分析纯。
3.2溶液配制3.2.1 0.1%甲酸水溶液：量取甲酸（3.1.2）1 mL，用水稀释至1000 mL，用滤膜（4.2）过滤后备用。
3.2.2 5 mmol/L甲酸铵水溶液：称取甲酸铵（3.1.3）0.315 g，用水稀释至1000 mL，用滤膜（4.2）过滤后备用。
3.2.3 5 mmol/L甲酸铵乙腈溶液：称取甲酸铵（3.1.3）0.315 g，加水50 mL溶解后，用乙腈稀释至1000 mL，用滤膜（4.2）过滤后备用。
3.3标准品苯乙双胍、丁二胍、二甲双胍、伏格列波糖、阿卡波糖、维达列汀、罗格列酮、西他列汀、吡格列酮、氯磺丙脲、达格列净、格列吡嗪、甲苯磺丁脲、醋磺己脲、妥拉磺脲、瑞格列奈、卡格列净、格列齐特、格列波脲、格列本脲、那格列奈、格列美脲、曲格列酮、格列喹酮、莫格他唑、GW501516、环格列酮标准品的中文名称、英文名称、CAS登录号、分子式、相对分子质量详见附录A中的表A.1，各标准品纯度均≥95%。
卡格净列说明书
卡格净列说明书商品名：Invokana 通用名：Canagliflozin 中文名：卡格列净药企：Janssen Pharmaceuticals, Inc.适应症：用于治疗成年患者的II型糖尿病（type 2 diabetes mellitus），不适用于I型糖尿病或糖尿病酮症酸中毒（diabetic ketoacidosis）。
剂型规格：本品为胶囊状膜包衣片，有100mg和300mg两种规格，100mg 片为黄色，300mg片为白色，一面印有CFZ，另一面印有100或300。
推荐剂量为100mg每天，有耐药性的患者可增量至300mg每天，第一餐餐前服用。
中度肾功能障碍（45<eGFR<60mL/min/1.73m2）限定100mg每天，重度肾功能障碍（eGFR<45mL/min/1.73m2）不能使用本品。
禁忌症：对本品有严重过敏史、重度肾功能障碍、晚期肾病或需要透析的患者。
活性成分：Canagliflozin。
本品使用Canagliflozin的1/2结晶水合物，几乎不溶于水。
口服降糖药：Invokana <wbr>(Canagliflozin)片（2013-03-29）作用机理：钠-葡萄糖共转运体（sodium-glucose linked transporter, SGLT）一种葡萄糖转运蛋白，有两种亚型即SGLT1和SGLT2，分别分布于小肠粘膜和肾小管，能够将葡萄糖转运进血液。
Canagliflozin能抑制SGLT2，使肾小管中的葡萄糖不能顺利重吸收进入血液而随尿液排出，从而降低血糖浓度。
不良反应：症状性低血压、肾功能损害、高钾血症、低血糖症（与胰岛素或促胰岛素分泌药物联用时）、生殖器真菌感染、过敏反应、LDL-C升高、心血管病风险。
构效关系：JMC2010-6355相关合成专利：US2005233988（化合物）；WO2008069327A1（晶型）；WO2009035969A1（工艺）；US2010099883A1（工艺）；WO2011047113A1（工艺）；WO2012140120A1（工艺）；WO2012154812A1（晶型）。
KARL STORZ 产品说明书：Anterior Cruciate Ligament Recons
System forAnterior Cruciate Ligament Reconstructionwith rectangular bone tunnelsusing the quadriceps tendonA R T 55 3.0 12/2020-E2© K A R L S T O R Z 96152052 A R T 55 3.0 12/2020E W -EThe Quadriceps TendonThe quadriceps tendon is used in cruciate ligament revision surgery and, more and more frequently, for the primary reconstruction of the anterior (ACL) and posterior (PCL) cruciate ligaments.1The quadriceps tendon has also emerged as a suitable graft source for the reconstruction of the medial patellofemoral ligament (MPFL).2This is mainly due to the following properties of the quadriceps tendon:Benefits of the quadriceps tendon:• L ower harvest site morbidity in comparison to the patellar tendon • Harvesting with or without a bone block possible • Good biomechanical propertiesA special tendon harvesting system was designed to provide fast, safe and atraumatic tendon harvesting, featuring the following properties:• R eproducible technique• Safe subcutaneous tendon harvesting • Defined harvesting depth • Attractive cosmetic resultsStudies on the Quadriceps Tendon1Fink C, Herbort M, Abermann E, Hoser C. Minimally invasive harvest of a quadriceps tendon graft with or without a bone block. Arthros Tech 2014Herbort M, Tecklenburg K, Zantop T, Raschke MJ, Hoser C, Schulze M, Petersen W, Fink C. Single-bundle anterior cruciate ligament reconstruction: a biomechanical cadaveric study of a rectangular quadriceps and bone-patellar tendon-bone graft configuration versus a round hamstring graft. Arthroscopy. 2013 Dec. 29(12):1981-90Lund B, Nielsen T, Faunø P , Christiansen SE, Lind M. Is quadriceps tendon a better graft choice than patellar tendon? A prospective randomized study. Arthroscopy. 2014 May 30(5): 593-8Sasaki N, Farraro KF , Kim KE, Woo SL. Biomechanical evaluation of the quadriceps tendon autograft for anterior cruciate ligament reconstruction: a cadaveric study. Am J Sports Med. 2014 Mar 42(3): 723-30Adams D Ph.D., Mazzocca A M.D., and Fulkerson J M.D. Residual strength of the quadriceps versus patellar tendon after harvesting a central free tendon graft. Arthroscopy: The Journal of Arthroscopic and Related Surgery, Vol 22, No 1 (January), pp 76-79. 2006Joseph M, Fulkerson J, Nissen C, Sheehan TJ. Short-term recovery after anterior cruciate ligament reconstruction: a prospective comparison of three autografts. Orthopedics. 2006 March 29(3):243-8DeAngelis J and Fulkerson J. Quadriceps Tendon: A reliable alternative for reconstruction of the ACL. Clin Sports Med 26(4), October, 20072Fink C, Veselko M, Herbort M, Hoser C, 2014. Minimal invasive reconstruction of the MPFL using the quadriceps tendon. Arthros Tech 2014, 3(3) e325 - e329 [Epub ahead of print]N oteENDOWORLD ® “Quadriceps Tendon Harvesting System” (96152047) is available on request.3© K A R L S T O R Z 96152052 A R T 55 3.0 12/2020E W -ESubcutaneous harvesting of quadriceps tendon using a special system via a minimal skin incision.The quadriceps tendon (QT) can be usedwith or without a bone block.For cruciate ligament reconstruction, an oscillating saw can be used to harvest a bone block from the proximal patella.Cruciate ligament reconstruction techniques using the semitendinosus and/or gracilis tendon have gained increasing attention in recent years. However, there has been little focus on the quadriceps tendon.Today many knee surgeons value the quadriceps tendon not only as a revision graft, but also use the quadriceps tendon more and more frequently for primary reconstruction of the anterior (ACL) and posterior (PCL) cruciate ligaments.For more information about the System for Anterior Cruciate Ligament Reconstruction with rectangular bone tunnels using the Quadriceps tendon, please refer to the Silver Book, code 96155016: Anatomic reconstruction of the Anterior Cruciate Ligament – Quadriceps tendon and rectangular bone tunnels. Fink C, Hoser C, Gföller P and Herbort M.Link to video4©KARLSTORZ9615252ART553.12/22EW-E System for ACL Reconstruction with Rectangular Bone Tunnelsusing the Quadriceps TendonThe actual anatomy of the anterior cruciate ligament insertion site gave rise to the idea of asystem that would best match the insertion-site anatomy.In cooperation with Prof. Christian Fink, Sportsclinic Austria (Innsbruck, Austria), a compactsystem was developed for creating rectangular femoral and tibial bone tunnels.5© K A R L S T O R Z 96152052 A R T 55 3.0 12/2020E W -EA range of different target guides with various offsets are available for use in positioning the femoral tunnel. The femoral tunnel is created using the “Medial Portal Aimers”.Application Description1. Measuring the graft diameter with the tendon thickness tester2. Rasps and Dilators for creation of the femoral bone tunnelQR code for the femoral tunnel6© K A R L S T O R Z 96152052 A R T 55 3.0 12/2020E W -E3. Dilators for creating the tibial tunnelQR code for the tibial tunnelThetibial aimer features a special tip design.This allows the placement of two K-wires to align the tunnel on the tibial plateau.A conventional round or a rectangular tibial tunnel can be created.7© K A R L S T O R Z 96152052 A R T 55 3.0 12/2020E W -EBenefits of creating rectangular bone tunnels:• E nables the creation of both femoral and tibial rectangular tunnels • Rasp with smooth side to protect the PCL• D istal tip of the tibial aimer with target marks for additional K-wires to align the tunnel on the tibial plateau • A natomical insertion area for the graft used • Compact instrument set• Compatible with existing instruments for cruciate ligaments • Suitable for primary and revision ACL• P rovides good anatomical and cosmetically attractive results for the patient in combination with minimally invasive harvesting system for the quadriceps tendonTipsIn revision surgery, it is often advantageous to reuse a previously placed round tibial tunnel and only create a rectangular femoral tunnel.If a patellar tendon graft is used as a bone-ligament-bone graft, it is also recommended to create a femoral bone tunnel and a conventional round tibial tunnel.8© K A R L S T O R Z 96152052 A R T 55 3.0 12/2020E W -ESystem Components• Tendon thickness tester• Rasps and dilators for femoral rectangular bone tunnels • Target aimer and dilators for tibial rectangular bone tunnelsTendon thickness tester:– For measuring the following bone blocks: 8.0 mm, 9.0 mm, 10.0 mm and 12.0 mm x 5.0 mmRasps:– 8.0 and 10.0 mm widths– Each with 11.0 mm rasp depth – 3 sides with cutting teeth – 1 smooth side–Tip with 4.5 mm outer diameter to accommodate 2.4 mm K-wires– Laser marked in 5.0 mm increments – Removal aid at the handleDilator, femoral:– 8.0, 9.0, 10.0 and 12.0 mm wide and 5.0 mm thick – 20.0 mm at full dilation width– Laser marked in 5.0 mm increments –Removal aid at the handle9© K A R L S T O R Z 96152052 A R T 55 3.0 12/2020E W -EAimer, tibial:– 98° fixed bending angle– Distal tip with target marking for additional K-wires to align tunnel on the tibial plateau– Target sleeve with additional ventral and dorsal K-wire guide – Target sleeve with measuring scale for tibial tunnel lengthDilator, tibial:– 8.5, 9.5, 10.5 and 12.5 mm wide and 5.5 mm thick – 55.0 mm at full dilation width– Laser marked in 5.0 mm increments –Removal aid at the handle10© K A R L S T O R Z 96152052 A R T 55 3.0 12/2020E W -EInstruments28185QS Q uadriceps Tendon Cutter, for subcutaneous terminal cutting ofthe quadriceps tendon28185MH H andle, for use with Quadriceps Tendon Knives 28185FA – FF andQuadriceps Tendon Separators 28185EA – EC28185GA R asp, femoral, cannulated, straight, coarse, one side smooth,width 8 mm, height 5 mm, working length 15 cm 28185GBSame,width 10 mm28185MB T endon Thickness Tester, for determining the thickness of thequadriceps tendon11© K A R L S T O R Z 96152052 A R T 55 3.0 12/2020E W -E28729CF T ibial Target Guide, for the placement of a maximum of 3 paralleldrilling wires28185HA D ilator, rectangular, femoral, width 8 mm, height 5 mm,working length 15 cm 28185HB S ame, width 9 mm 28185HC S ame, width 10 mm 28185HD S ame, width 12 mm28185IA D ilator, rectangular, tibial, width 8.5 mm, height 5.5 mm,working length 15 cm 28185IB S ame, width 9.5 mm 28185IC S ame, width 10.5 mm 28185ID S ame,width 12.5 mm12© K A R L S T O R Z 96152052 A R T 55 3.0 12/2020E W -EKnives for quadriceps tendon harvestingfor cruciate ligament reconstructionKnives for quadriceps tendon harvestingfor MPFL reconstruction© K A R L S T O R Z 96152052 A R T 55 3.0 12/2020E W -ENotes© K A R L S T O R Z 96152052 A R T 55 3.0 12/2020E W -ENotes15© K A R L S T O R Z 96152052 A R T 55 3.0 12/2020E W -ENotesKARL STORZ SE & Co. KGDr.-Karl-Storz-Straße 34, 78532 Tuttlingen/Germany Postbox 230, 78503 Tuttlingen/Germany Phone: +49 7461 708-0 Fax: +49 7461 708-105E-Mail:******************96152052 A R T 55 3.0 12/2020E W -E。
Bacharach MGD-100产品说明书
1: ZONE ET CONDITIONS D'UTILISATIONLe Bacharach MGD-100 est un instrument servant à la surveillance continue de gaz réfrigérants, combustibles et toxiques. Le système est proposé avec un ou deux niveaux d'alarme, il est constitué de 1 à 6 capteurs de gaz à distance raccordés à un contrôleur et alimentés par celui-ci.Le contrôleur est alimenté en 12 VCC ou 100-230 VCA 50-60 Hz (spécification à la commande).N° de réf. : 6109-9002Révision 013 janvier 20162: CONSIGNES DE SÉCURITÉMANUEL DE L'UTILISATEUR : Avant d'utiliser ce matériel, lisez attentivement et respectez scrupuleusement le Manuel de l'utilisateur (référence 6109-9000). L'utilisateur doitcomprendre parfaitement et appliquer scrupuleusement les instructions. Utilisez le matériel uniquement aux finsdécrites et dans les conditions précisées dans ce document.RESPECT DU CODE : Conformez-vous à toutes les lois, règles et réglementations locales et nationales relatives à ce matériel.PIÈCES D'ORIGINE : Utilisez uniquement des pièces de rechange et des accessoires d'origine Bacharach, faute de quoi le bon fonctionnement du matériel pourrait être altéré.UTILISATION RÉSERVÉE AU TECHNICIEN : Cet appareil doit être installé par un technicien suffisamment qualifié quipourra l'installer dans le respect des présentes instructions et des normes applicables dans le domaine ou le pays concerné. Les utilisateurs de l'appareil doivent connaître les règlements et normes de leur domaine et pays pour l'utilisation de cet appareil. Ces remarques ne sont qu'indicatives et leconstructeur n'est aucunement responsable de l'installation ou de l'utilisation de cet appareil.Le non-respect des présentes instructions et des règles applicables dans le domaine pour l'installation et l'utilisation de l'appareil peuvent conduire à desblessures graves voire mortelles et le constructeur ne saurait en être tenu responsable.SÉCURITÉ DE MONTAGE : Ce moniteur doit être raccordé par un interrupteur ou disjoncteurconvenablement repéré, positionné de façon adéquate et facilement accessible pour le mettre hors tension.AVERTISSEMENT : Respectezscrupuleusement les instructions du Manuel de l'utilisateur (référence 6109-9000) disponible sur .ATTENTION : NE PAS MONTER le MGD-100 dans un emplacement pouvant contenir des liquides ou des vapeurs inflammables. L'utilisation de tout équipement électrique dans un tel environnement met en danger la sécurité.DÉTECTEUR et CONTRÔLEUR DE GAZ GUIDE D'INSTALLATION RAPIDE3: POIDS ET DIMENSIONSFACTEURS ENVIRONNEMENTAUX : Examinez soigneusement toute la gamme des conditions environnementales auxquelles seront exposés les appareils.GAZ CIBLE : Il convient de prendre enconsidération les données physiques du gaz ou de la vapeur à détecter.APPLICATION : Il est nécessaire d'évaluer les détails spécifiques à l'application (p. ex. les fuites possibles, les courants ou le tirant d'air...).ACCESSIBILITÉ : Il convient de prévoir le niveau d'accessibilité nécessaire pour l'entretien.ACCESSOIRES : Il faut penser au type de matériel en option et d'accessoires qui seront utilisés avec le système.FACTEURS ÉLECTRONIQUES : Le systèmecontient des composants électroniques sensibles qui peuvent être facilement endommagés. Ne pas toucher ni perturber ces composants.Montez le MGD-100 et le contrôleur en tenant compte des facteurs ci-dessus, des dimensions du produit (voir Section 3), des longueurs maximales de câblage (voir Section 5) et des dimensions de montage correspondantes indiquées sur les illustrations qui suivent.4: MONTAGE(1,0 po)(1,0 po)Filetage M42Filetage 1” BSPTête à distanceExdSurveillance de conduite de ventilation PRV/IP66tête 1pouce BSP Boîtier standard IP41Boîtier IP66Débit et dimensions de gaines prises en charge pour le Boîtier de capteur standardIP41Boîtier de contrôleur pour 1-2 capteursVisSiège social mondial 621 Hunt Valley CircleNew Kensington, PA 15068, États-UnisTéléphone : 724-334-5000 • Télécopie : 724-334-5001Numéro gratuit (depuis les États-Unis d'Amérique) : 1-800-736-4666Site Web : Email:********************5: CÂBLAGE1: Dénudez le fil sur 5 à 7 mm (0,2 à 0,25 po).2: Raccordez les fils comme indiqué.AVERTISSEMENT CONCERNANT LES FILS BLINDÉS : Raccordez le blindage des fils électriques à la terre dusystème de commande central (p. ex. le châssis, la barre-bus de terre...).AVERTISSEMENT : Le câbled'alimentation secteur doit être d'un type homologué en fonction des réglementations locales. Leraccordement à l'alimentation secteur doit s'effectuer par une fiche et une prise homologuées commutées et protégées par fusible facilementaccessible (ou selon les règlements de câblage locaux), à moins de 3 m (10 pi) de l'unité de commande.OUVERTURES POUR CÂBLES : Le boitier de contrôleur métallique IP51 dispose d'un certain nombred'ouvertures PG7 pour presse-étoupes ou bouchons. Chaque émetteur MGD-100 IP41 dispose d'uneouverture pour un presse-étoupe M20, ainsi que d'une débouchure en option. Chaque émetteur MGD-100 IP66 dispose de 3 ouvertures. Ces ouvertures peuvent servir au câblage sur le terrain, à la fixation directe d'un capteur ou au câblage vers un capteur à distance. Il convient de fermer les ouvertures non utilisées avec un bouchon et un joint adaptés, de classe IP ou Ex d correspondante à celle de l'appareil.114A Georges Street Lower Dun Laoghaire • Co Dublin • IrlandeTéléphone : +353 1 284 6388 • Télécopie : +353 1 284 6389REMARQUE : Pour le raccordement du câblage, vous devez commencer par ouvrir le boîtier du MGD-100. Le couvercle du boîtier IP66 est fixé par quatre vis imperdables.REMARQUE : Une fois le câblageeffectué, remontez méticuleusement le boîtier et ses composants, en prenant note du repérage du câble nappe et des connecteurs de capteur. Une foisl'installation terminée, veuillez consulter le Manuel de l'utilisateur (référence6109-9000) pour obtenir des instructions détaillées sur l'enregistrement descapteurs et la configuration du MGD-100pour son bon fonctionnement.Veuillez consulter le Manuel de l'utilisateur(référence 6109-9000) sur pour obtenir des instructions détaillées sur l'accès aux composants internes pour le câblage.。
Beckman Coulter 产品说明书
Product No. C-1432Certified BlankThe Certified Blank reagent contains unlabeled synthetic microspheres of uniform size. These serve as a qualitative control to determine the "noise" level of individual flow cytometers. Certification verifies the detection of the blank beads in fluorescence channels below that of unstained human leukocytes. The product is offered in buffered saline with stabilizer and 0.1% sodium azide (see MSDS)* as preservative. DescriptionStandardization and reproducibility of instrument performance is critical in flow cytometry.1-8 There are a variety of means for monitoring instrument parameters. It is necessary to define fluorescein threshold in order to ensure that a given flow cytometer has the necessary sensitivity for immunophenotyping of cell surface antigens expressed at low density. Instruments should be maintained at a sensitivity level greater than that detected for autofluorescent cells. Fluorescence threshold is defined as the level above which a fluorescence signal can be measured by an instrument. Non-fluorescent particles can be used to make such determinations.ProcedureMaterials required but not provided: Appropriately sized test tubes.Unstained human peripheral blood with eryth-rocytes lysed using a commercial lysing re-agent.Instrumentation required but not provided:Flow cytometer.Optically align flow cytometer per manufacturer’s specifications.Other optional instrument performance QC proce-dures:If FITC/PE two color analysis is routine practice in the laboratory, adjustfluorescence PMT (Photomultiplier tube)and color compensation usingestablished reagent(s)/protocol or FlowCytometry Compensation Kit (SigmaStock No. COMP-1).Analyze Microbead Standards (Sigma Product No. M-0162). Record the PMTvoltages and mean channel fluorescenceon an appropriate log sheet. The resultsshould be consistent with establishedtarget conditions and target channels.The use of Microbead Standards permitsthe direct comparison of fluorescenceintensity data over time.Vigorously shake Certified Blank to achieve a uniform suspension.Add 0.5 ml (approximately 10-15 drops or 200,000 microspheres) to an appropriately sized test tube.Collect data gated on singlets of the Certified Blank for 10,000 events.Record the peak (median) channel for each of the fluorescence parameters. Mean channel may be alternatively used, however, note that mean and median channels are not inter-changeable.Run the lysed, unstained whole blood sample on the flow cytometer, set a gate for lymphocytes and collect 10,000 events.1.Record the mean or median channel at eachPMT.pare the mean or median channels of theunstained human lymphocytes to that of the Certified Blank. If the mean channels of the unstained lymphocytes is above the values for the Certified Blank microbeads, the instrument has sufficient sensitivity for immunophenotyping assay.ProductInformationResultsThe Certified Blank should appear below (to the left of) unstained leukocytes. Each lot is accompanied by a lot-specific certificate verifying the expected mean channel values for a properly calibrated instrument. The Certified Blank serves as a qualitative control for monitoring flow cytometer sensitivity and the level of background fluorescent signals.Figure 1Fluorescence of the Certified Blank in the FITC PMT.Figure 2Autofluorescence of unstained lymphocytes in the FITC PMT.Figure 3Fluorescence of the Certified Blank in the PE PMT.Figure 4Autofluorescence of unstained lymphocytes in the PE PMT.LimitationsProper storage (2-8?C) and handling are essen-tial.This reagent is extremely sensitive to slight changes in pH. The Certified Blank microspheres are maintained at physiological pH (7.2). It is, therefore, critical that pH be carefully controlled in performing quantitative and qualitative flow cyto-metry analyses. Vigorously mixing microspheres prior to use is essential in obtaining a uniform suspension. Establishment of consistent, reproducible mean channel performance data for an appropriate reference standard, i.e., Microbead Standards, is crucial to proper interpretation of results obtained with Certified Blank.StorageStore at 2-8E C. Do Not Freeze.*Due to the sodium azide content a material safety data sheet (MSDS) for this product has been sent to the attention of the safety officer of your institution. Consult the MSDS for information regarding hazards and safe handling practices.References1.Proposed Guidelines: Clinical Applicationsof Flow Cytometry. Quality Assurance andImmunophenotyping of Peripheral BloodLymphocytes. National Committee forClinical Laboratory Standards. DocumentH42-P, 9, 13 (1989).1.Shapiro, H., Practical Flow Cytometry, 2ndEd., Alan R. Liss, Inc., New York, 267-270(1988).2.Keren, D., Flow Cytometry in Clinical Diag-nosis, ASCP Press, Chicago, 27-28 (1989).3.Horan, P., and M. Loken, "A Practical Guideto the Use of Flow Systems", In: Flow Cyto-metry Instrumentation and Data Analysis, M.Van Dilla, et al., (Eds.), Academic Press,NY, 260-280 (1985).4.Horan, P., and J. Kappler, J. Immunol.Meth., 18, 309 (1977).5.McCoy, J., et al., Am. J. Clin. Pathol., 93,Suppl. 1:S27-S37 (1990).6.Giorgi, J.V., et al., Clin. Immunol. Immunop-athol., 55, 173 (1990).7.Parker, J.W., et al., Clin. Immunol. Immuno-pathol., 55, 187 (1990).Sigma warrants that its products conform to the information contained in this and other Sigma publications. Purchaser must determine the suitability of the product for its particular use. See reverse side of invoice or packing slip for additional terms and conditions of the sale. Issued 08/95.。
- 1、下载文档前请自行甄别文档内容的完整性，平台不提供额外的编辑、内容补充、找答案等附加服务。
- 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
- 3、如文档侵犯您的权益，请联系客服反馈,我们会尽快为您处理(人工客服工作时间：9:00-18:30)。
卡格净列说明书整理表姓名:职业工种:申请级别:受理机构:填报日期:附件1食品中二甲双胍等非食品用化学物质的测定BJS 2019011.范围本标准规定了食品（含特殊食品）中二甲双胍、苯乙双胍、丁二胍、伏格列波糖、阿卡波糖、维达列汀、罗格列酮、西他列汀、吡格列酮、氯磺丙脲、达格列净、格列吡嗪、甲苯磺丁脲、醋磺己脲、妥拉磺脲、瑞格列奈、卡格列净、格列齐特、格列波脲、格列本脲、那格列奈、格列美脲、曲格列酮、格列喹酮、莫格他唑、GW501516、环格列酮等27种非食品用化学物质的高效液相色谱-串联质谱测定方法。
本标准适用于茶叶、奶粉、饼干、酒、饮料等食品（包括上述类似基质的片剂、胶囊剂等形式的特殊食品）中二甲双胍等27种非食品用化学物质的测定。
2.原理试样粉碎后经甲醇超声提取，过滤后，上清液供高效液相色谱-串联质谱测定，外标法定量。
3.试剂和材料除另有规定，本方法所用试剂均为分析纯或以上规格，水为GB/T 6682规定的一级水。
3.1 试剂3.1.1 乙腈（CH3CN）：色谱纯。
3.1.2 甲酸（HCOOH）：色谱纯。
3.1.3 甲酸铵（HCOONH4）：色谱纯。
3.1.4 甲醇（CH3OH）：分析纯。
3.2溶液配制3.2.1 0.1%甲酸水溶液：量取甲酸（3.1.2）1 mL，用水稀释至1000 mL，用滤膜（4.2）过滤后备用。
3.2.2 5 mmol/L甲酸铵水溶液：称取甲酸铵（3.1.3）0.315 g，用水稀释至1000 mL，用滤膜（4.2）过滤后备用。
3.2.3 5 mmol/L甲酸铵乙腈溶液：称取甲酸铵（3.1.3）0.315 g，加水50 mL溶解后，用乙腈稀释至1000 mL，用滤膜（4.2）过滤后备用。
3.3标准品苯乙双胍、丁二胍、二甲双胍、伏格列波糖、阿卡波糖、维达列汀、罗格列酮、西他列汀、吡格列酮、氯磺丙脲、达格列净、格列吡嗪、甲苯磺丁脲、醋磺己脲、妥拉磺脲、瑞格列奈、卡格列净、格列齐特、格列波脲、格列本脲、那格列奈、格列美脲、曲格列酮、格列喹酮、莫格他唑、GW501516、环格列酮标准品的中文名称、英文名称、CAS登录号、分子式、相对分子质量详见附录A中的表A.1，各标准品纯度均≥95%。
3.4标准溶液的配制3.4.1 标准储备液（5 mg/mL）：准确称取伏格列波糖、阿卡波糖、达格列净、卡格列净、曲格列酮、环格列酮各标准品（3.3）50.0 mg（精确至0.0001 g），分别置于10 mL容量瓶中，用甲醇（3.1.4）溶解并稀释至刻度，摇匀，制成浓度为5 mg/mL标准储备液A，-20℃保存，有效期3个月。
3.4.2标准储备液（100 μg/mL）：准确称取苯乙双胍、丁二胍、二甲双胍、维达列汀、罗格列酮、西他列汀、吡格列酮、氯磺丙脲、格列吡嗪、甲苯磺丁脲、醋磺己脲、妥拉磺脲、瑞格列奈、格列齐特、格列波脲、格列本脲、那格列奈、格列美脲、格列喹酮、莫格他唑、GW501516各标准品（3.3）10.0 mg（精确至0.0001 g），分别置于100 mL容量瓶中，用甲醇（3.1.4）溶解并稀释至刻度，摇匀，制成浓度为100 μg/mL标准储备液B，-20 ℃保存，有效期3个月。
3.4.3混合标准中间液A：分别准确吸取伏格列波糖和阿卡波糖的标准储备液（3.4.1）及苯乙双胍、丁二胍、二甲双胍的标准储备液(3.4.2)各1 mL，置于同一100mL容量瓶中，用甲醇（3.1.4）稀释至刻度，摇匀，制成混合标准中间液（A），其中伏格列波糖和阿卡波糖浓度为50 μg/mL，苯乙双胍、丁二胍、二甲双胍浓度为1 μg/mL。
3.4.4混合标准中间液B：分别准确吸取达格列净、卡格列净、曲格列酮、环格列酮的标准储备液(3.4.1)各1 mL及维达列汀、罗格列酮、西他列汀、吡格列酮、氯磺丙脲、格列吡嗪、甲苯磺丁脲、醋磺己脲、妥拉磺脲、瑞格列奈、格列齐特、格列波脲、格列本脲、那格列奈、格列美脲、格列喹酮、莫格他唑、GW501516的标准储备液(3.4.2)各1 mL，置于同一100 mL容量瓶中，用甲醇（3.1.4）稀释至刻度，摇匀，制成混合标准中间液B，其中达格列净、卡格列净、曲格列酮、环格列酮浓度为50 μg/mL，维达列汀等18个化合物浓度为1 μg/mL。
3.4.5 混合标准工作溶液A：分别准确吸取混合标准中间液A(3.4.3)各0.1 mL、0.2 mL、0.4 mL、1.0 mL、2.0 mL，置于20 mL容量瓶中，用甲醇（3.1.4）稀释至刻度，摇匀，作为系列标准工作溶液S1~S5，伏格列波糖和阿卡波糖的浓度均依次为0.25 μg/mL、0.5 μg/mL、1.0 μg/mL、2.5 μg/mL、5.0 μg/mL；苯乙双胍、丁二胍、二甲双胍的浓度均依次为5 ng/mL、10 ng/mL、20 ng/mL、50 ng/mL、100 ng/mL。
3.4.6混合标准工作溶液B：分别准确吸取混合标准中间液B(3.4.4)各0.1 mL、0.2 mL、0.4 mL、1.0 mL、2.0 mL，置于20 mL容量瓶中，用甲醇（3.1.4）稀释至刻度，摇匀，作为系列标准工作溶液S(1)~S(5)，达格列净、卡格列净、曲格列酮、环格列酮4个化合物的浓度均依次为0.25 μg/mL、0.5 μg/mL、1.0 μg/mL、2.5 μg/mL、5.0 μg/mL；维达列汀等18个化合物浓度均依次为5 ng/mL、10 ng/mL、20 ng/mL、50 ng/mL、100 ng/mL。
4.仪器和设备4.1高效液相色谱-串联质谱仪，配有电喷雾（ESI）离子源。
4.2分析天平：感量0.0001g。
4.3超声波水浴。
5.分析步骤5.1试样的制备5.1.1茶叶、奶粉、饼干、片剂、胶囊取适量研细，称取粉末1 g（精确至0.0001 g）置于50 mL量瓶中，加入甲醇（3.1.4）45 mL，振摇，超声提取10 min，放冷，加甲醇（3.1.4）定容至刻度，摇匀，用滤膜（0.22 µm，有机相型）过滤，取续滤液，可根据实际浓度适当稀释至线性范围内，供液相色谱-质谱联用仪分析。
5.1.2 饮料、口服液准确吸取1 mL，置50 mL量瓶中，加入甲醇（3.1.4）45 mL，振摇，超声提取10 min，放冷，加甲醇（3.1.4）定容至刻度，摇匀，用滤膜（0.22 µm，有机相型）过滤，取续滤液，可根据实际浓度适当稀释至线性范围内，供液相色谱-质谱联用仪分析。
5.1.3酒准确吸取1 mL，置蒸发皿中，水浴蒸至无醇味，用适量甲醇（3.1.4）溶解并转移至50 mL 量瓶中，振摇，超声提取10 min，放冷，加甲醇（3.1.4）定容至刻度，摇匀，用滤膜（0.22 µm，有机相型）过滤，取续滤液，可根据实际浓度适当稀释至线性范围内，供液相色谱-质谱联用仪分析。
5.2 仪器参考条件5.2.1 色谱条件5.2.1.1 系统1（测定苯乙双胍、丁二胍、二甲双胍、伏格列波糖、阿卡波糖）a) 色谱柱：酰胺基键合杂化颗粒色谱柱(2.1×100 mm，3.5 µm)，或性能相当者；b）流动相：A为含5 mmol/L的甲酸铵溶液（3.2.2），B为5 mmol/L甲酸铵乙腈溶液（3.2.3），梯度洗脱程序见表2；c）流速：300 μL/min；d) 柱温：70℃；e) 进样量：1 μL。
5.2.1.2 系统2（测定维达列汀、罗格列酮、西他列汀、吡格列酮、氯磺丙脲、达格列净、格列吡嗪、甲苯磺丁脲、醋磺己脲、妥拉磺脲、瑞格列奈、卡格列净、格列齐特、格列波脲、格列本脲、那格列奈、格列美脲、曲格列酮、格列喹酮、莫格他唑、GW501516、环格列酮）a) 色谱柱：亲水三键键合相实心核颗粒色谱柱(2.1×100 mm，2.7 µm)，或性能相当者；b）流动相：A为含0.1%甲酸水溶液（3.2.1），B为乙腈（3.1.1），梯度洗脱程序见表3；c）流速：300μL/min；d) 柱温：30℃；e) 进样量：1μL。
5.2.2 质谱条件a) 离子源：电喷雾离子源（ESI源）。
b) 检测方式：多反应监测（MRM）。
c) 扫描模式：正离子模式或负离子模式。
d）干燥气、雾化气、鞘气、碰撞气等均为高纯氮气或其他合适气体，使用前应调节相应参数使质谱灵敏度达到检测要求，毛细管电压、干燥气温度、鞘气温度、鞘气流量、喷嘴电压、碰撞能量、碎裂电压等参数应优化至最佳灵敏度，监测离子对和定量离子对等信息详见附录A。
5.3 定性测定按照高效液相色谱-串联质谱条件测定试样和标准工作溶液，记录试样和标准溶液中各化合物的色谱保留时间，以相对于最强离子丰度的百分比作为定性离子对的相对丰度，记录浓度相当的试样与标准工作溶液中相应成分的相对离子丰度。
当试样中检出与27种化合物中某标准品色谱峰保留时间一致的色谱峰（变化范围在±2.5%之内），并且相对离子丰度允许偏差不超过表4规定的范围，可以确定试样中检出相应化合物。
5.4定量测定5.4.1标准曲线的制作将混合标准工作溶液A（3.4.5）分别按仪器参考条件（5.2.1.1和5.2.2）进行测定，将混合标准工作溶液B（3.4.6）分别按仪器参考条件（5.2.1.2和5.2.2）进行测定，得到相应的标准溶液的色谱峰面积。
以混合标准工作溶液的浓度为横坐标，以色谱峰的峰面积为纵坐标，绘制标准曲线。
5.4.2试样溶液的测定将试样溶液（5.1）按仪器参考条件（5.2）进行测定，得到相应的样品溶液的色谱峰面积。
根据标准曲线得到待测液中组分的浓度，平行测定次数不少于两次。
6.空白试验除不加试样外，均按试样同法操作。
7.结果计算将液相色谱-质谱测得浓度代入下式计算含量： (1)式中：X — 试样中各待测物的含量，单位为毫克每千克（mg/kg）；c — 从标准曲线中读出的供试品溶液中各待测物的浓度，单位为纳克每毫升（ng/mL）；V — 样液最终定容体积，单位为毫升（mL）；m —试样溶液所代表的质量，单位为克（g）；K— 稀释倍数。
计算结果以重复性条件下获得的两次独立测定结果的算术平均值表示，结果保留三位有效数字。
8.检测方法的灵敏度、精密度、专属性8.1 灵敏度固体和液体取样量为1 g或1 mL，定容体积为50 mL时，伏格列波糖、阿卡波糖、达格列净、卡格列净、曲格列酮、环格列酮的定量限为12.5 mg/kg或12.5 mg/L；苯乙双胍、丁二胍、二甲双胍、维达列汀、罗格列酮、西他列汀、吡格列酮、氯磺丙脲、达格列净、格列吡嗪、甲苯磺丁脲、醋磺己脲、妥拉磺脲、瑞格列奈、卡格列净、格列齐特、格列波脲、格列本脲、那格列奈、格列美脲、曲格列酮、格列喹酮、莫格他唑、GW501516、环格列酮的定量限为0.25 mg/kg 或0.25 mg/L。