盐酸氨基葡萄糖USP质量标准翻译
氨基葡萄糖硫酸钠盐USP32标准
氨基葡萄糖硫酸钠盐U S P32标准Glucosamine Sulfate Sodium Chloride(C6H14NO5)2SO4·2NaCl 573.31Bis(d-Glucose, 2-amino-2-deoxy-), sulfate sodium chloride complex.Bis(2-Amino-2-deoxy- -d-glucopyranose) sulfate sodium chloride complex (-,-) [38899-05-7].» Glucosamine Sulfate Sodium Chloride contains not less than 98.0 percent a nd not morethan 102.0 percent of (C6H14NO5)2SO4·2NaCl calculated on the dried basis. Packaging and storage— Preserve in tight, light-resistant containers.USP Reference standards 11—USP Glucosamine Hydrochloride RS .Identification—A: Infrared Absorption 197K.Test solution— Transfer about 50 mg of Glucosamine Sulfate Sodium Chlorid e to a centrifuge tube,and dissolve in 2 mL of water. Add about 0.5 mL of barium chloride TS, and c entrifuge.Evaporate the supernatant, and dry the residue at 105 for 2 hours. The IR spe ctrum correspondsto that of a similar preparation of USP Glucosamine Hydrochloride RS, except that the additionof barium chloride TS is omitted.B: It meets the requirements of the tests for Chloride 191 and Sodium 191. C: The retention time of the major peak in the chromatogram of the Assay pre paration correspondsto that in the chromatogram of the Standard preparation, as obtained in the As say.D: In the test for the Content of sulfate, after the addition of barium chloride T S, a whiteprecipitate is formed.Specific rotation 781S: between +50.0 and +55.0.Test solution: 35 mg per mL. Measure the specific rotation 3 hours after sampl e preparation.pH 791 : between 3.0 and 5.0, in a solution containing 20 mg per mL.Loss on drying 731 — Dry it at 105 for 2 hours: it loses not more than 1.0% of its weight.Residue on ignition 281 : between 22.5% and 26.0%.Potassium— Acidify 5 mL of a solution (1 in 20) with 6 N acetic acid, and add 5 drops ofsodium cobaltinitrite TS: no precipitate is formed.Arsenic, Method II 211 : 3 µg per g.Heavy metals, Method II 231 : 0.001%.Content of sulfate— Transfer about 1 g of Glucosamine Sulfate Sodium Chlori de, accurately weighed, to a 250-mL beaker, and dissolve in about 100 mL of water. Add 4 mL of 6 N hydrochloric acid. Heat the solutionto boiling, and add, with constant stirring, sufficient boiling barium chloride T S to completely precipitate the sulfate.Add an additional 2 mL of barium chloride TS, and digest on a steam bath for 1 hour. Pass the mixturethrough ashless filter paper, transferring the residue quantitatively to the filter, and wash the residue withhot water until no precipitate is obtained when 1 mL of silver nitrate TS is add ed to 5 mL of washing.Transfer the paper containing the residue to a tared crucible. Char the paper, without burning, and ignitethe crucible and its contents to constant weight. Calculate the content of sulfat e by multiplying the weightobtained by 0.4116. The content of sulfate is between 16.3% and 17.3%. Assay—Phosphate buffer, Mobile phase, Standard preparation, and Chromatographic system— Proceed asdirected in the Assay under Glucosamine Hydrochloride.Assay preparation— Transfer about 100 mg of Glucosamine Sulfate Sodium Chloride, accurately weighed, to a 100-mL volumetric flask. Dissolve in 30 mL of water, shake by mechanical means, dilute with water to volume,and mix.Procedure— Proceed as directed in the Assay under Glucosamine Hydrochlor ide. Calculate thepercentage of (C6H14NO5)2SO4·2NaCl in the portion of Glucosamine Sulfate Sodium Chloride takenby the formula:10,000(573.31/431.26)(C / W)(rU / rS)in which 573.31 is the molecular weight of the glucosamine sulfate sodium chl oride and 431.26 istwice the molecular weight of glucosamine HCl; W is the weight, in mg, of Glu cosamine SulfateSodium Chloride used to prepare the Assay preparation; and the others terms are as defined therein.Auxiliary Information— Please check for your question in the FAQs before conUSP32–NF27 Page 1031Pharmacopeial Forum: Volume No. 33(4) Page 692Chromatographic Column—GLUCOSAMINE SULFATE SODIUM CHLORIDEChromatographic columns text is not derived from, and not part of, USP 32 or NF 27项目标准（美国药典版）性状白色结晶性粉末比旋度+52°—+54°pH值 3.00—4.50铁离子≤10PPM重金属≤10PPM干燥失重≤1.00%含量98.0%-102.0%（以干基计）灼烧残渣23.5—25.0%氯化物≤14.00%硫酸盐16.3%-17.3%有机挥发杂质符合要求微生物检验细菌总数酵母、霉菌沙门氏菌大肠杆菌不大于500/g 不大于100/g 不得检出不得检出包装和储存保存在密封闭光的容器内有效期两年。
盐酸氨基葡萄糖质量标准及检验操作规程
文件名称盐酸氨基葡萄糖质量标准及检验操作规程文件编号JS-SPE-YL-002版本号BS1.0 第 1 页共 7 页一、目的：规范辅料盐酸氨基葡萄糖的取样及检验操作程序，为盐酸氨基葡萄糖的采购、检验及贮存提供依据，建立评定盐酸氨基葡萄糖质量和批准放行的标准，确保物料的正常使用。
二、适用范围：适用于采购人员的采购依据，取样人员的取样依据，检验人员的检验依据，仓库保管人员的贮存依据，复核人的复核依据，质量部长的批准放行和监督的依据，QA监控的依据，盐酸氨基葡萄糖药材质量评价的依据。
三、责任者：采购人员按本规范项下规定的标准进行采购；取样人按本规范项下的取样方法执行取样操作及书写记录；检验人按本规范项下的检验方法执行检验操作及书写记录；复核人按本规范进行复核检查；质量部长按本规范进行监督和批准放行；QA按本规范对药材质量实施监控；仓库保管人员按本规范项下的贮存条件进行保管。
四、内容：1物料名称：中文名：盐酸氨基葡萄糖拼音名：Yiansuan Anjiputaotang 拉丁名：Glucosamine Hydrochloride2 物料代码：YL0073 标准依据：《中国药典》2010年版二部P12344 经批准的供应商：5 来源：本品为2-氨基-2-脱氧-D(+)-吡喃葡萄糖盐酸盐，按干燥品计算，含C6H14O3NCl应为98.0%~102%。
6 取样方法：6.1取样器具：不锈钢剪刀、不锈钢勺、75%乙醇、手套、自封袋、取样标签、留样标签6.2盐酸氨基葡萄糖属直接入药辅料，须按取样规则在洁净取样车或洁净取样间取样。
6.3用不锈钢剪刀将外包装打开，在洁净取样车或洁净取样间条件下，按2～3个不同部位各取盐酸氨基葡萄糖5～10g；每一包件取样量为25～50g，最终抽取量为200g。
20g用做微生物限度检查，其他180g取好的样品平均分成三份分别放入自封袋中，封口。
其中2份贴取样标签，用于检验和复验；1份贴留样标签，用于留样观察。
氨基葡萄糖硫酸软骨素USP标准
USP 35Dietary Supplements / Glucosamine1333Staining reagent for 5 min. Then stir the solution gently Ginseng, American—see American Ginsengfor 1 min. Remove the membrane, and destain in 5%acetic acid until the background clears.Acceptance criteria: The principal spot of the Samplesolution has the same migration as the principal spot ofthe Standard solution.[N OTE—Document the results by taking a picture within Ginseng, Asian—see Asian Ginseng15 min of completion of destaining.]STRENGTH•C ONTENT OF G LUCOSAMINEDiluent: Transfer 29 µL of acetic acid and 5 mL of aceto-nitrile to a 100-mL volumetric flask containing 50 mL ofwater. Dilute with water to volume.Ginseng, Siberian—see EleutheroBorate buffer: 0.2 M (76.3 g/L of sodium borate inwater) adjusted with hydrochloric acid TS to a pH of 9.5Acetate buffer: 6.80 g/L of sodium acetate trihydrate inwater adjusted with dilute acetic acid to a pH of 5.9Derivatizing reagent: In a 14-mL polypropylene culturetube, dissolve 50 mg of o-phthalaldehyde in 1.25 mL ofanhydrous methanol. Add 50 µL of 3-mercaptopropionic Sodium Tablets acid and 11.2 mL of Borate buffer, and mix gently. Allowto stand in the dark for 30 min before use. [N OTE—Rea-DEFINITION gent strength is maintained by adding 10 µL of 3-mer-Glucosamine and Chondroitin Sulfate Sodium Tablets are captopropionic acid every 2 days. Storage should be in prepared from either Glucosamine Hydrochloride, Gluco-the dark at room temperature, and can be used for NMT samine Sulfate Sodium Chloride, Glucosamine Sulfate Po- 2 weeks.]tassium Chloride, or a mixture of any of them, with Mobile phase: Methanol and Acetate buffer (1:9) Chondroitin Sulfate Sodium. Tablets contain NLT 90.0%Standard solution: 1.0 mg/mL of USP Glucosamine Hy-and NMT 120.0% of the labeled amounts of chondroitin drochloride RS in water. Allow to stand at room temper-sulfate sodium and glucosamine (C6H13NO5).ature for 1 h.[N OTE—Chondroitin Sulfate Sodium is extremely hygro-Sample solution: Transfer an equivalent to 25 mg of scopic once dried. Avoid exposure to atmosphere, and glucosamine, from finely powdered Tablets (NLT 20), to weigh promptly.] a 25-mL volumetric flask. Dilute with Diluent to volume.Mix on a vortex mixer to suspend the powder in solu-IDENTIFICATION tion. Sonicate in a 65° water bath for 20 min. Remove •A. The retention time of the major peaks of the Sample from the bath, stir for 5 min with the aid of a magnetic solution correspond to those of the Standard solution, as stirrer, and centrifuge.obtained in the test for Content of Glucosamine.Chromatographic system•B. E LECTROPHORESIS〈726〉 (See Chromatography 〈621〉, System Suitability.)Barium acetate buffer: Dissolve 25.24 g of barium ace-Mode: LCtate in 900 mL of water. Adjust with acetic acid to a pH Detector: UV 340 nmof 5.0, and dilute with water to 1000 mL.Column: 3.0-mm × 5-cm; packing L1Staining reagent: 0.1% (w/v) toluidine blue in 0.1 M Flow rate: 1 mL/minacetic acid Injection size: 10 µLStandard solution: Use the Standard solution of middle System suitabilityconcentration from the test for Content of Chondroitin Samples: Five individual aliquots of the Standard solu-Sulfate Sodium.tion derivatized as directed in the Analysis. Each deriva-Sample solution: Prepare as directed in the test for Con-tized aliquot is injected only once.tent of Chondroitin Sulfate Sodium.[N OTE—The relative retention times for the β-anomer Analysis: Fill the chambers of an electrophoresis appara-and the α-anomer are 1.0 and 1.8, respectively. The tus suitable for separations on cellulose acetate mem-retention time for the β-anomer is NLT 4 min.] branes1 (a small submarine gel chamber or one dedi-Suitability requirementscated to membrane media) with Barium acetate buffer.Relative standard deviation: NMT 2.0% from five Soak a cellulose acetate membrane 5–6 cm × 12–14 cm replicate injectionsin Barium acetate buffer for 10 min, or until evenly wet-Analysisted, then blot dry between two sheets of absorbent pa-Samples:Standard solution and Sample solutionper. Using an applicator2 suitable for electrophoresis, ap-Transfer 100 µL of the Derivatizing reagent and 100 µL of ply equal volumes (0.5 µL) of the Sample solution and the Standard solution or Sample solution to a vial con-Standard solution to the brighter side of the membrane taining 400 µL of Borate buffer. Allow the derivatization held in position in an appropriate applicator stand or on to proceed for 1 min. Inject the derivatized solutionsa separating bridge in the chamber. Ensure that both immediately after the derivatization reaction.ends of the membrane are dipped at least 0.5–1.0 cm Calculate the percentage of the labeled amount of glu-deep into the buffer chambers. Apply a constant 60 V (6cosamine (C6H13NO5) in the portion of Tablets taken: mA at the start) for 2 h. [N OTE—Perform the applicationof solutions and voltage within 5 min because further Result = (r U/r S) × (C S/C U) × (M r1/M r2) × 100 drying of the blotted paper reduces sensitivity.]Place the membrane in a plastic staining tray, and with r U= peak response of the β-anomer from the the application side down, float or gently immerse in derivatized Sample solutionr S= peak response of the β-anomer from the1Suitable cellulose acetate membranes for electrophoresis are available from derivatized Standard solutionMalta Chemetron SRL, Milano, Italy (); FlukaChemical Corp., Milwaukee, WI; and DiaSys Corp., Waterbury, CT C S= concentration of USP Glucosamine().Hydrochloride RS in the Standard solution2Suitable applicators are available from DiaSys Corp., Waterbury, CT(mg/mL)() and Helena Laboratories, Beaumont, TX().1334Glucosamine / Dietary Supplements USP 35C U= nominal concentration of glucosamine in the Calculate the percentage of the labeled amount ofSample solution (mg/mL)glucosamine (C6H13NO5) dissolved: M r1= molecular weight of glucosamine, 179.17Result = (r U/r S) × (C S×V/L) × (M r1/M r2) × 100 M r2= molecular weight of glucosaminehydrochloride, 215.63r U= peak area from the derivatized Sample solution Acceptance criteria: 90.0%–120.0%r S= peak area from the derivatized Standard•C ONTENT OF C HONDROITIN S ULFATE S ODIUMsolutionDiluent: Weigh about 297 mg of monobasic potassiumC S= concentration of USP Glucosaminephosphate, 492 mg of dibasic potassium phosphate, andHydrochloride RS in the Standard solution 250 mg of polysorbate 80, and transfer into a 1-L(mg/mL)beaker. Dissolve in approximately 900 mL of water, andV= volume of Medium, 900 mL adjust with potassium hydroxide or phosphoric acid to aL= label claim of glucosamine (mg/Tablet) pH of 7.0 ± 0.2. Dilute with water to 1 L, and mixM r1= molecular weight of glucosamine, 179.17 thoroughly.M r2= molecular weight of glucosamineStandard solutions: 1.5, 1.0, and 0.5 mg/mL of USPhydrochloride, 215.63 Chondroitin Sulfate Sodium RS in waterTolerances: NLT 75% of the labeled amount of Sample solution: Transfer an equivalent to 100 mg ofglucosamine (C6H13NO5) is dissolved.chondroitin sulfate sodium, from finely powdered TabletsDetermine the percentage of the labeled amount of (NLT 20), to 60 mL of water. Shake to suspend thechondroitin sulfate sodium dissolved by using the powder in solution. Sonicate in a 65° water bath for 20following method.min. Remove from the bath, and stir or shake for 5 min.Standard solutions, Titrant, and Diluent: Proceed as Dilute with water to 100 mL, and centrifuge or passdirected in the test for Content of Chondroitin Sulfate through a suitable filter.Sodium.Titrimetric systemSample solution: Use the solution under test.(See Titrimetry 〈541〉.)Analysis: Proceed as directed in the test for Content of Mode: Photometric titrationChondroitin Sulfate Sodium.Titrant: 1 mg/mL of cetylpyridinium chloride in water.Calculate the percentage of the labeled amount of Degas before use.chondroitin sulfate sodium dissolved: Endpoint detection: Turbidimetric with a photoelectricprobeResult = (C×V/L) × 100AnalysisSamples:Standard solutions and Sample solution C= determined concentration of chondroitin Transfer 5.0 mL of each Standard solution and the sulfate sodium in the Sample solutionSample solution to separate titration vessels. Add 25(mg/mL)mL of Diluent to each. Stir until a steady reading is V= volume of Medium, 900 mLobtained with a photoelectric probe either at 420,L= label claim of chondroitin sulfate sodium550, or 660 nm. Set the instrument to zero in(mg/Tablet)absorbance mode. Titrate with Titrant using the Tolerances: NLT 75% of the labeled amount ofphotoelectric probe to determine the endpoint chondroitin sulfate sodium is dissolved.turbidimetrically. From a linear regression equation•W EIGHT V ARIATION OF D IETARY S UPPLEMENTS〈2091〉: Meet calculated using the volumes of Titrant consumed the requirementsversus concentrations of the Standard solutions,determine the concentration of chondroitin sulfate ADDITIONAL REQUIREMENTSsodium in the Sample solution.•P ACKAGING AND S TORAGE: Preserve in tight, light-resistant Calculate the percentage of the labeled amount of containers.chondroitin sulfate sodium in the portion of Tablets•L ABELING: The label indicates the types of glucosamine taken:salts contained in the article and the species source fromwhich the chondroitin was derived. Label it to state the Result = (C/C U) × 100source(s) of chondroitin sulfate sodium, whether bovine,porcine, avian, or a mixture of any of them. The label C= determined concentration of chondroitin states on the front panel the content of chondroitinsulfate sodium in the Sample solution sulfate sodium on the dried basis.(mg/mL)•USP R EFERENCE S TANDARDS〈11〉C U= nominal concentration of chondroitin sulfate USP Chondroitin Sulfate Sodium RSsodium in the Sample solution (mg/mL)USP Glucosamine Hydrochloride RSAcceptance criteria: 90.0%–120.0%PERFORMANCE TESTS•D ISINTEGRATION AND D ISSOLUTION OF D IETARY S UPPLEMENTS〈2040〉: Meet the requirements for Dissolution Glucosamine HydrochlorideMedium: Water; 900 mLApparatus 2: 75 rpmTime: 60 minDetermine the percentage of the labeled amount ofglucosamine (C6H13NO5) dissolved by using thefollowing method.Standard solution: Prepare as directed in the test forContent of Glucosamine. Dilute with a suitable quantity ofwater, if necessary.C6H13NO5·HCl215.63 Sample solution: Use the solution under test.D-Glucose, 2-amino-2-deoxy-, hydrochloride;Borate buffer, Acetate buffer, Derivatizing reagent,2-Amino-2-deoxy-β-D-glucopyranose hydrochloride [66-84-Mobile phase, and Chromatographic system: Proceed2].as directed in the test for Content of Glucosamine.Analysis: Proceed as directed in the test for Content ofGlucosamine.。
盐酸氨基葡萄糖 欧洲药典标准
盐酸氨基葡萄糖欧洲药典标准
盐酸氨基葡萄糖是一种常用的药物，其欧洲药典标准如下：
1. 名称：盐酸氨基葡萄糖（Glucosamine Hydrochloride）
2. 分子式：C6H13NO5·HCl
3. 分子量：215.63
4. 外观：白色结晶性粉末
5. 溶解性：易溶于水，微溶于乙醇
6. 鉴别试验：
（1）红外光谱法：与对照品的红外吸收光谱图相符。
（2）氯化铵试验：样品在加入氯化铵后立即产生白色沉淀。
7. 含量测定：
采用高效液相色谱法（HPLC）进行含量测定。
样品在流动相中以260nm处检测。
结果应符合规定的标准。
8. 水分测定：
样品在105℃下干燥至恒重，得到的水分含量应不超过1.0%。
9. 重金属含量：
采用原子吸收光谱法进行重金属含量测定。
结果应符合规定的标准。
10. 细菌限度：
采用菌落计数法进行细菌限度测定。
结果应符合规定的标准。
以上就是盐酸氨基葡萄糖的欧洲药典标准，这些标准对于保证药品的质量和安全性具有重要意义，同时也为相关行业提供了技术支持和指导。
N-乙酰氨基葡萄糖-USP38
USP 38Dietary Supplements / N-Acetylglucosamine5865 Dietary SupplementsOfficial Monographs[N OTE—The relative retention times for N-acetyl-glucosamine and glucosamine are 1.0 and about 2.8, N-Acetylglucosaminerespectively.]Suitability requirementsSignal-to-noise ratio: NLT 10 for the glucosaminepeak, System suitability solutionResolution: NLT 5.0 between the N-acetyl-glucosamine and glucosamine peaks, System suitabil-ity solutionTailing factor: NMT 2.0, Standard solutionRelative standard deviation: NMT 2.0%, StandardsolutionC8H15NO6221.21Analysis2-(Acetylamino)-2-deoxy-D-glucose;Samples:Standard solution and Sample solutionN-Acetyl-D-Glucosamine [7512-17-6].Calculate the percentage of N-acetylglucosamine(C8H15NO6) in the portion of N-Acetylglucosamine DEFINITION taken:N-Acetylglucosamine contains NLT 98.0% and NMT 102.0%of N-acetylglucosamine (C8H15NO6), calculated on the Result = (rU/r S) × (C S/C U) × 100dried basis.r U= peak response from the Sample solution IDENTIFICATION rS= peak response from the Standard solution •A. I NFRARED A BSORPTION〈197K〉CS= concentration of USP N-Acetylglucosamine RS •B. It meets the requirements in the test for Optical Rota-in the Standard solution (mg/mL) tion 〈781S〉, Specific Rotation.CU= concentration of N-Acetylglucosamine in the •C. The retention time of the major peak of the Sample Sample solution (mg/mL) solution corresponds to that of the Standard solution, as Acceptance criteria: 98.0%–102.0% on the dried basis obtained in the Assay.IMPURITIESASSAY•R ESIDUE ON I GNITION〈281〉: NMT 0.1%•P ROCEDURE•C HLORIDE AND S ULFATE, Chloride〈221〉: NMT 0.1% Buffer: Transfer 3.5g of dibasic potassium phosphate to•E LEMENTAL I MPURITIES—P ROCEDURES〈233〉a 1-L volumetric flask, and add sufficient water to dis-Acceptance criteriasolve. Add 0.25mL of ammonium hydroxide, dilute Arsenic: NMT 1µg/gwith water to volume, and mix. Adjust with phosphoric Lead: NMT 10µg/gacid to a pH of 7.5.•R ELATED C OMPOUNDSMobile phase: Acetonitrile and Buffer (75:25)Buffer, Mobile phase, Diluent, System suitability solu-Diluent: Acetonitrile and water (50:50)tion, Chromatographic system, and System suitabil-System suitability solution: 1.0mg/mL of USP N-ity: Proceed as directed in the Assay.Acetylglucosamine RS and 0.6mg/mL of USP Glucosa-Sample solution: 2.5mg/mL of N-Acetylglucosamine in mine Hydrochloride RS in Diluent DiluentStandard solution: 1.0mg/mL of USP N-Acetyl-Analysisglucosamine RS in Diluent Sample:Sample solutionSample solution: 1.0mg/mL of N-Acetylglucosamine in Calculate the percentage of each impurity in the por-Diluent tion of N-Acetylglucosamine taken:Chromatographic system(See Chromatography 〈621〉, System Suitability.)Result = (rU/r T) × 100 Mode: LCDetector: UV 195 nm r U= peak response of each impurity from the Column: 4.6-mm × 15-cm; 3-µm packing L8Sample solutionColumn temperature: 35°r T= sum of the peak responses from the Sample Flow rate: 1.5mL/min solutionInjection volume: 10µLSystem suitabilitySamples:System suitability solution and Standardsolution5866N -Acetylglucosamine / Dietary SupplementsUSP 38Acceptance criteriaDEFINITIONIndividual impurity: NMT 0.5% N -Acetyltyrosine contains NLT 98.5% and NMT 101.0% of Total impurities: NMT 2.0%N -acetyltyrosine (C 11H 13NO 4), as N -acetyl-L -tyrosine, calcu-•L IMIT OF G LUCOSAMINElated on the dried basis.Buffer, Mobile phase, Diluent, System suitability solu-IDENTIFICATIONtion, Chromatographic system, and System suitabil-•A . I NFRARED A BSORPTION 〈197K 〉ity: Proceed as directed in the Assay .•B . O PTICAL R OTATION , Specific Rotation 〈781S 〉Standard solution: 0.6mg/mL of USP Glucosamine Hy-Sample solution: 10mg/mLdrochloride RS in DiluentAcceptance criteria: NLT +46.0° and NMT +49.0°, de-Sample solution: 50mg/mL of N -Acetylglucosamine in termined at 20°Diluent •C . The R F value of the principal spot of the Sample solu-Analysistion in the test for Organic Impurities corresponds to that Samples: Standard solution and Sample solutionof Standard solution 1.Calculate the percentage of glucosamine in the portion of N -Acetylglucosamine taken:ASSAY•P ROCEDUREResult = (r U /r S ) × (C S /C U ) × (M 1/M 2) × 100Sample solution: Dissolve about 180mg of N -Acetyltyrosine, weighed, in 50mL of carbon dioxide-r U= peak response of glucosamine from thefree water.Sample solutionTitrimetric system r S = peak response of glucosamine from the(See Titrimetry 〈541〉.)Standard solutionMode: Direct titrationC S = concentration of USP GlucosamineTitrant: 0.1 N sodium hydroxide VS Hydrochloride RS in the Standard solution Endpoint detection: Potentiometric(mg/mL)Equivalency: Each mL of 0.1 N sodium hydroxide VS C U = concentration of N -Acetylglucosamine in theis equivalent to 22.32mg of N -acetyltyrosine Sample solution (mg/mL)(C 11H 13NO 4).M 1= molecular weight of glucosamine, 179.17M 2= molecular weight of glucosamineIMPURITIEShydrochloride, 215.63•R ESIDUE ON I GNITION 〈281〉: NMT 0.1%Acceptance criteria: NMT 1.0%•C HLORIDE AND S ULFATE , Chloride 〈221〉Sample: 0.7gSPECIFIC TESTSStandard: 0.40mL of 0.01 N hydrochloric acid •O PTICAL R OTATION , Specific Rotation 〈781S 〉Acceptance criteria: NMT 200ppm Sample solution: 20mg/mL in water, perform the •C HLORIDE AND S ULFATE , Sulfate 〈221〉measurement 3 h after sample preparation.Sample: 1.2gAcceptance criteria: +39.0° to +43.0°Standard: 0.25mL of 0.020 N sulfuric acid •P H 〈791〉Acceptance criteria: NMT 200ppm Sample solution: 10mg/mL in water •I RON 〈241〉: NMT 20ppmAcceptance criteria: 6.0–8.0•L OSS ON D RYING 〈731〉Analysis: Dry a sample at 105° for 2 h.Delete the following:Acceptance criteria: NMT 0.5%•M ELTING R ANGE OR T EMPERATURE 〈741〉: 196°–205°••H EAVY M ETALS , Method 1 〈231〉: NMT 10ppm •(Official 1-•M ICROBIAL E NUMERATION T ESTS 〈2021〉: The total aerobic Dec-2015)bacterial count does not exceed 103 cfu/g; the total com-•O RGANIC I MPURITIESbined molds and yeasts count does not exceed 103 cfu/Adsorbent: 0.25-mm layer of chromatographic silica g.gel mixture•A BSENCE OF S PECIFIED M ICROORGANISMS 〈2022〉: Meets the Standard stock solution 1: 8mg/mL of USP N -Acetyl-L -requirements of the tests for absence of Salmonella spe-tyrosine RS in a mixture of water, glacial acetic acid,cies and Escherichia coliand alcohol (3:3:94)Standard solution 1: Dilute Standard stock solution 1ADDITIONAL REQUIREMENTSwith alcohol to obtain a solution having a known con-•P ACKAGING AND S TORAGE : Preserve in tight, light-resistant centration of about 0.4mg/mL.containers.Standard solution 2: 0.8mg/mL of USP L -Tyrosine RS •USP R EFERENCE S TANDARDS 〈11〉dissolved in a mixture of glacial acetic acid and water USP N -Acetylglucosamine RS(1:1), and diluted with alcoholUSP Glucosamine Hydrochloride RSSample solution: Transfer 0.8g of N -Acetyltyrosine to a 10-mL volumetric flask, dissolve in 6mL of a mixture of glacial acetic acid and water (1:1), and dilute with alco-hol to volume.Application volume: 5µLN -AcetyltyrosineDeveloping solvent system: A mixture of ammonia and 2-propanol (3:7)Spray reagent: Dissolve 0.2g of ninhydrin in 100mL of a mixture of butanol and 2N acetic acid (95:5).Analysis: Proceed as directed for Chromatography 〈621〉,Thin-Layer Chromatography. After air-drying the plate,repeat the development process. After air-drying a sec-ond time, examine the plate under short-wave UV light,C 11H 13NO 4223.2and record principal and secondary spots. Spray the N -Acetyl-L -tyrosine;plate with Spray reagent , and heat between 100° and (2S )-2-(Acetylamino)-3-(4-hydroxyphenyl)propanoic acid)105° for about 15 min. Examine the plate under white [537-55-3].light, and record the principal and secondary spots.。
盐酸氨基葡萄糖胶囊说明书
盐酸氨基葡萄糖胶囊说明书盐酸氨基葡萄糖胶囊(普力得)用于缓解和预防骨关节炎的关节(膝、髋、脊柱、肩、手腕、踝等)软骨磨损、退化所致的疼痛、僵硬、肿胀和活动困难。
下面是店铺整理的盐酸氨基葡萄糖胶囊说明书，欢迎阅读。
盐酸氨基葡萄糖胶囊商品介绍通用名：盐酸氨基葡萄糖胶囊生产厂家: 北京康必得药业有限公司批准文号：国药准字H20070173药品规格：42粒药品价格：￥298元盐酸氨基葡萄糖胶囊说明书【通用名称】盐酸氨基葡萄糖胶囊【商品名称】盐酸氨基葡萄糖胶囊(普力得)【英文名称】GlucosamineHydrochlorideCapsules【拼音全码】YanSuanAnJiPuTaoTangJiaoNang(PuLiDe)【主要成份】盐酸氨基葡萄糖，辅料为明胶胶囊壳。
化学名：2-氨基-2-脱氧-D-(+)-吡喃葡萄糖盐酸盐分子式：C6H13NO5HCl分子量：215.63【性状】盐酸氨基葡萄糖胶囊(普力得)为胶囊剂，内容物为白色或类白色粉末。
【适应症/功能主治】用于缓解和预防骨关节炎的关节(膝、髋、脊柱、肩、手腕、踝等)软骨磨损、退化所致的疼痛、僵硬、肿胀和活动困难。
【规格型号】0.24g*180s+42s【用法用量】口服，一次1～2粒，一日3次，一般疗程4～12周。
【不良反应】罕见轻度的胃肠不适、如恶心、便秘、腹胀和腹泻;皮肤红斑、皮疹、瘙痒。
【禁忌】对盐酸氨基葡萄糖胶囊(普力得)过敏者禁用。
【注意事项】1.盐酸氨基葡萄糖胶囊(普力得)宜在饭时或饭后服用，可减少胃肠道不适，特别是有胃溃疡的患者。
2.严重肝、肾功能不全者慎用。
3.用药一疗程后，症状未缓解，请咨询医师或药师。
4.孕妇和哺乳期妇女慎用。
5.对盐酸氨基葡萄糖胶囊(普力得)过敏者禁用，过敏体质者慎用。
6.盐酸氨基葡萄糖胶囊(普力得)性状发生改变时禁止使用。
7.请将盐酸氨基葡萄糖胶囊(普力得)放在儿童不能接触的地方。
8.如正在使用其他药品，使用盐酸氨基葡萄糖胶囊(普力得)前请咨询医师或药师。
氨基葡萄糖盐酸盐HPLC含量检测方法(USP40)中文
氨基葡萄糖盐酸盐HPLC含量检测方法(USP40)
含量测定
●过程
缓冲液：在1-L容量瓶中溶解3.5克磷酸二氢钾在水中。
加入0.25毫升氢氧化铵，用水稀释至体积，混合。
用磷酸调节pH值为7.5
流动相：乙腈和缓冲区（75∶25）
稀释剂：乙腈和水（50∶50）
标准溶液：3.8毫克/毫升USP氨基葡萄糖盐酸盐标准品稀释剂
样品溶液：3.8毫克/毫升氨基葡萄糖盐酸盐稀释剂（注意：用机械方法摇匀以帮助溶解）
●色谱系统
（参考色谱法<621>，系统适应性）
模式：LC
检测器：UV 195nm
色谱柱： 4.6-mm × 15-cm，5-µm填充 L8
柱温：35℃
流速：1.5ml/min
进样量; 10 µL
●系统适应性
样品：标准溶液（氨基葡萄糖部分的峰值在约10分钟，由于氯离子的存在色谱图上在孔隙体积附近会出现一个较大的附加峰）
适应性要求
拖尾因子：氨基葡萄糖峰不超过2.0
理论塔板数≥1500
相对标准偏差：≤2.0%
●检测：
样品：标准溶液和样品溶液氨基葡萄糖(C 6 H 13 NO 5 · HCl)含量的计算
结果=(r
U /r
S
) × (C
S
/C
U
) × 100
r
U
=样品溶液的峰面积
r
S
=标准溶液的峰面积
C
S
=氨基葡萄糖盐酸盐标准溶液的浓度
C
U
=氨基葡萄糖盐酸盐样品溶液的浓度接受标准：98.0%-102%（以干计）。
氨基葡萄糖盐酸盐标准
食品添加剂氨基葡萄糖盐酸盐3结构式、分子式和相对分子量结构式：分子式：相对分子量：4要求性状产品为白色或类白色结晶粉末。
理化指标应符合表1的规定。
表1 微生物指标应符合表2的规定。
表25试验方法除非另有说明，在分析中仅使用确认为分析纯的试剂和GB/T6682中规定的水。
感官将样品置于清洁、干燥的白瓷盘中，在自然光线下，观察其色泽和状态。
氨基葡萄糖盐酸盐（）含量仪器设备液相色谱仪；氨基柱×25cm，5μm)；μL定量环；电子分析天平(万分之一)。
分析要求鉴别：在含量测定项下记录色谱图，对照品溶液的主峰保留时间与样品溶液的主峰保留时间应一致；系统适应性：拖尾因子≤2，理论塔板数≥1500，RSD≤2%。
色谱条件流速：min；色谱柱温度：35℃；检测器：紫外检测器；检测器波长：195nm；进样量：10μL；运行时间：20分钟；溶液制备流动相溶液制备流动相A：乙腈；流动相B：称取磷酸氢二钾，加入的氨水，用水定容至1L，混匀，用磷酸调节PH至；流动相A：流动相B=75:25。
蒸馏水和所用试剂均使用色谱级，流动相要用μm的有机相滤膜过滤后并超声15分钟，待用。
稀释液的配制乙腈:水=50:50，蒸馏水和乙腈均使用色谱级，流动相要用μm的有机相滤膜过滤后并超声15分钟，待用。
对照品液精确称取对照品三份(精确至置于100mL容量瓶中，用稀释液溶解并定容至刻度，摇匀待用。
供试品液精确称取烘干的供试品两份(精确至置于100mL容量瓶中，用稀释液溶解并定容至刻度，摇匀待用。
样品与对照品溶液需要通过μm有机相滤头过滤后进样。
操作步骤系统适应性按液相色谱仪检验操作规程，开启仪器并使仪器达到稳定状态后,用相同体积的进样针将三个对照品溶液按顺序依次注入色谱（定量环10μL），每个对照品分别进两针，共计六针，分别计算校正因子f1……f6，利用校正因子按下式计算得：RSD≤2%。
相对标准偏差计算公式：式中：RSD——相对标准偏差；f i——第i针工作对照品的校正因子,是相应工作对照品的重量与面积的比值；f——工作对照品的平均校正因子；n——连续取了n针工作对照品校正因子。
盐酸氨基葡萄糖胶囊有关物质测定方法研究
盐酸氨基葡萄糖胶囊有关物质测定方法研究张德柱;宋愿智;沈登林【摘要】Objective To establish an HPLC method for the determination of related substances in Glucosamine Hydrochloride Cap-sules .Methods The separation was performed on a C18 (250 mm × 4 .6 mm ,5 μm) column at room temperature .The mobile phase was a mixture of sodium 1-heptanesulfonate solution and acetonitrile at a flow-rate of 1 .0 mL · min-1 .The detection wave-length was at 195 nm .Results The Glucosamine Hydrochloride Capsules was stable with acid destruction ,but unstable with alka-li ,high temperature and strong oxidative destruction .The linear range was 6 .32-31 .60 μg · mL -1 .Conclusion This method issimple ,accurate ,and rapid with high specificity .It is applicable for the determination of related substances in Glucosamine Hydro-chloride Capsules .%目的：建立测定盐酸氨基葡萄糖胶囊有关物质的高效液相色谱方法。
USP药典的验证中英文对照
VALIDATION OF COMPENDIAL PROCEDURES 药典方法的验证Test procedures for assessment of the quality levels of pharmaceutical articles are subject to various requirements. According to Section 501 of the Federal Food, Drug, and Cosmetic Act, assays and specifications in monographs of the United States Pharmacopeia and the National Formulary constitute legal standards. The Current Good Manufacturing Practice regulations [21 CFR 211.194(a)] require that test methods, which are used for assessing compliance of pharmaceutical articles with established specifications, must meet proper standards of accuracy and reliability. Also, according to these regulations [21 CFR 211.194(a)(2)], users of analytical methods describedin USP–NF are not required to validate the accuracy and reliability of these methods, but merely verify their suitability under actual conditions of use. Recognizing the legal status of USP and NF standards, it is essential, therefore, that proposals for adoption of new or revised compendial analytical procedures be supported by sufficient laboratory data to document their validity.用于评估药品质量的检验方法需要满足不同的要求。
硫酸氨基葡萄糖钾盐 USP
Glucosamine Sulfate Potassium Chloride(C 6H 14NO 5 )2 SO 4 ·2KCl 605.52Bis(D -Glucose, 2-amino-2-deoxy-), sulfate potassium chloride complex.Bis(2-Amino-2-deoxy--D -glucopyranose) sulfate potassium chloride complex (-,-) [38899-05-7].» Glucosamine Sulfate Potassium Chloride contains not less than 98.0 percent and not more than 102.0 percent of (C 6H 14NO 5 )2 SO 4 ·2KCl, calculated on the dried basis.Packaging and storage— Preserve in tight, light-resistant containers.USP R EFERENCE STANDARDS 11 —USP Glucosamine Hydrochloride RSIdentification—A: Infrared Absorption 197K . Test solution— Transfer about 50 mg of Glucosamine Sulfate Potassium Chloride to a centrifuge tube, and dissolve in 2 mL of water. Add about 0.5 mL of barium chloride TS, and centrifuge. Evaporate the supernatant, and dry the residue at 105 for 2 hours. The IR spectrum corresponds to that of a similar preparation of USP Glucosamine Hydrochloride RS , except that the addition of barium chloride TS is omitted.B: It meets the requirements of the tests for Chloride 191 and Potassium 191 .C: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.D: In the test for Content of sulfate, after the addition of barium chloride TS a white precipitate is formed. S PECIFIC ROTATION 781S : between +47 and +53.Test solution: 35 mg per mL. Measure the specific rotation 3 hours after sample preparation.P H 791 : between 3.0 and 5.0, in a solution containing 20 mg per mL.L OSS ON DRYING 731 — Dry it at 105 for 2 hours: it loses not more than 1.0% of its weight.R ESIDUE ON IGNITION 281 : between 26.5% and 31.0%.Sodium— A solution (1 in 10), tested on a platinum wire, does not impart a pronounced yellow color to a nonluminous flame.A RSENIC , Method II 211 : 3 µg per g.H EAVY METALS , Method II 231 : 0.001%.Content of sulfate— Transfer about 1 g of Glucosamine Sulfate Potassium Chloride, accurately weighed, to a 250-mL beaker, and dissolve in about 100 mL of water. Add 4 mL of 6 N hydrochloric acid. Heat the solution to boiling, and add, with constant stirring, sufficient boiling barium chloride TS to completely precipitate the sulfate. Add an additional 2 mL of barium chloride TS, and digest on a steam bath for 1 hour. Pass the mixture through ashless filter paper, transferring the residue quantitatively to the filter, and wash the residue with hot water until no precipitate is obtained when 1 mL of silver nitrate TS is added to 5 mL of washing. Transfer the paper containing the residue to a tared crucible. Char the paper, without burning, and ignite the crucible and its contents to constant weight. Calculate the content of sulfate by multiplying the weight obtained by 0.4116. The content of sulfate is between 15.5% and 16.5%. Assay—Diluent, Phosphate buffer, Mobile phase, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Glucosamine Hydrochloride.Assay preparation— Transfer about 187.5 mg of Glucosamine Sulfate Potassium Chloride, accurately weighed, to a 50-mL volumetric flask. Dissolve in 30 mL of Diluent, shake by mechanical means, dilute with Diluent to volume, and mix.Procedure— Proceed as directed in the Assay under Glucosamine Hydrochloride . Calculate the percentage of (C 6H 14NO 5 )2 SO 4 ·2KCl in the portion of Glucosamine Sulfate Potassium Chloride taken by the formula:(605.52/431.26)(10,000C / W )( r U / r S )in which 605.52 is the molecular weight of glucosamine sulfate potassium chloride and 431.26 is twice the molecular weight of glucosamine HCl; W is the weight, in mg, of Glucosamine Sulfate Potassium Chloride used to prepare the Assay preparation; and the other terms are as defined therein.Auxiliary Information— Please check for your question in the FAQs before contacting USP.USP34–NF29 Page 1167Pharmacopeial Forum : Volume No. 33(4) Page 692 Topic/QuestionContact Expert Committee Monograph Huy T. Dinh, M.S.Scientific Liaison1-301-816-8594(DS2010) Monographs - Dietary Supplements Reference StandardsRS Technical Services1-301-816-8129rstech@。
同类产品 比较
同类产品比较表1 ………………安利复合维生素C片& USANA 矿物维生素C 表2 ………………安利辅酶素Q10胶囊& USANA 心脏宝表3 ………………安利蛋白粉& USANA 黄豆蛋白奶表4 ………………安利小麦胚芽油营养胶囊& USANA E-保力表5 ………………安利倍立健& USANA 基本营养素表6 ………………安利多种营养片& USANA 儿童营养素表7 ………………安利葡萄籽抗氧化剂& USANA 葡萄籽精华表8 ………………山西葡立& 澳美奥泰灵& USANA 健骼宁Ⅱ表9 ………………安利大蒜甘草片& USANA 康蒜宝表10 ………………安利果蔬纤维素片& USANA 纤维素表11 ………………安利深海鲑鱼油胶囊& USANA 活力奥米加-3表5安利倍立健 USANA 基本营养素产地中国美国特点22种多种营养素（其中14种维生素、8种矿物质及微量元素）。
基本營養素是維生素、矿物质、生物类黃酮及抗氧化剂的完美結合。
其中超级抗氧化剂中，蘊含30种高效維生素、抗氧化剂及其他重要养分，配方均衡，可有效促进細胞新陈代谢，抵御游离基的侵害。
螯合性矿物质中，蘊含13种完整系列的重要矿物质，配方均衡，极易为人体吸收。
营养成分表（每次服用量）维生素A 1250 国际单位β胡萝卜素2250 国际单位维生素C 225毫克维生素B1 5.5毫克维生素B2 5.5毫克维生素B6 5.5毫克维生素B12 3.75微克维生素D3 165国际单位维生素E 17.5国际单位肌醇 20毫克烟酸12.5毫克叶酸150微克泛酸 10毫克生物素 90微克钙 323毫克镁 144毫克锌7.5毫克铁 2.15毫克铜 0.75毫克锰 2毫克铬17.5微克硒 6.5微克β胡萝卜素 4. 5毫克维生素C 650毫克钙抗坏血酸盐540毫克钾抗坏血酸盐324毫克镁抗坏血酸盐192毫克维生素D3 300国际单位维生素E 200国际单位维生素K 60微克维生素B1(硫胺素) 13.5毫克维生素B2 13.5毫克菸草醯胺及菸草酸 20毫克维生素B6 16毫克叶酸 250微克维生素B12 100微克维辛素 150微克班多生酸50毫克混合生育酚17毫克芦丁60毫克槲皮甘12毫克柑皮甘12毫克绿茶精华7.5毫克石榴精华 5毫克玉桂精华 2毫克越橘精华 500微克姜黄精华7.5毫克叶黄素300微克蕃茄红素150微克菠萝蛋白酶25毫克辅酶Q10 6毫克硫辛酸10毫克肌醇 50毫克盐酸L-半胱氨酸-水合物50毫克西兰花精华7.5毫克钙（柠檬酸钙）135毫克镁（柠檬酸镁、氧化镁、HVP*螫合物） 150毫克锌（柠檬酸锌）10毫克碘（碘化钾） 150微克硒（HVP*螫合物）100微克铜（葡萄糖酸铜） 1毫克锰（葡萄糖酸锰） 2.5毫克铬（粼吡啶甲酸铬） 150微克钼（HVP*螫合物） 25微克钒（硫酸氧钒） 20微克硅（HVP*螫合物）20微克硼（柠檬酸硼） 1.5毫克超级微量矿物质 1.5毫克*HVP 水解植物蛋白质推荐剂量每天两次，每次各一粒每天两次，每次各两粒价格 RMB422 2包装 90粒/包 HKD512/385 2瓶装112片/瓶（其中包括超级抗氧化剂及螯合性矿物质各1瓶）品质食品级GMP生产标准产品符合美国药典（USP）的效能、均一性及分解标准要求。
盐酸氨基葡萄糖USP质量标准翻译
盐酸氨基葡萄糖USP质量标准翻译盐酸氨基葡萄糖质量标准C6H13NO5·HCl，化学名D-葡萄糖-2-氨基-2-脱氧-盐酸盐，2-氨基-2脱氧-β-D-吡喃葡萄糖盐酸盐。
以干燥品计算，含盐酸氨基葡萄糖的量应为标示量的98.0%~102.0%。
包装和贮存：应密封避光贮存。
【鉴别】A. 本品的红外光吸收图谱应与硫酸软骨素钠对照品的图谱一致.B. 显氯化物的鉴别反应。
C. 在含量测定项下记录的色谱图中，供试品溶液主峰的保留时间应与对照品溶液主峰的保留时间一致。
【比旋度】取本品，精密称定，用水溶解并定量稀释制成每1ml 中约含25mg的溶液。
放置3小时后测定，比旋度应为+70°至+73°。
【pH】取本品，精密称定，用水溶解并定量稀释制成每1ml中约含20mg的溶液，pH值为3.0~5.0.【干燥失重】取本品，在105℃干燥2小时，减失重量不得过1.0%。
【炽灼残渣】不得过0.1%。
【硫酸盐】取本品0.1g，溶解，与0.25ml 硫酸（浓度0.010mol/L）对照液比较，不得更深（0.24%）。
【砷盐】不得过3μg/g。
【重金属】不得过0.001%。
【含量】磷酸盐缓冲液：量取1ml磷酸与2L水混合，并加入适量氢氧化钠调节pH至3.0。
流动相：磷酸盐缓冲液-乙腈溶液（3:2）。
超声15min后，并用0.5μm孔径的微孔滤膜过滤。
标准溶液：精密称定盐酸氨基葡萄糖标准品，制备浓度为1.0mg/ml的盐酸氨基葡萄糖对照品水溶液。
供试品溶液：精密称取100mg盐酸氨基葡萄糖至100ml容量瓶中，先加30ml水并采用机械式震动使之充分溶解，继续加水至刻度定容，摇匀。
色谱条件：检测波长：195nm色谱柱：C8柱（全多孔硅胶微粒键合C8官能团固定相）：4.6mm×25cm流速：0.6ml/min按照程序进行检测并记录图谱：氨基葡萄糖主峰拖尾因子不得大于2.0；平行进样测定结果之间的RSD%不得大于2.0%。
氨基葡萄糖盐酸盐标准
氨基葡萄糖盐酸盐标准 Document number：NOCG-YUNOO-BUYTT-UU986-1986UT食品添加剂氨基葡萄糖盐酸盐3结构式、分子式和相对分子量结构式：分子式：相对分子量：4要求性状产品为白色或类白色结晶粉末。
理化指标应符合表1的规定。
表1应符合表2的规定。
表2除非另有说明，在分析中仅使用确认为分析纯的试剂和GB/T6682中规定的水。
感官将样品置于清洁、干燥的白瓷盘中，在自然光线下，观察其色泽和状态。
氨基葡萄糖盐酸盐（）含量仪器设备液相色谱仪；氨基柱×25cm，5μm)；μL定量环；电子分析天平(万分之一)。
分析要求鉴别：在含量测定项下记录色谱图，对照品溶液的主峰保留时间与样品溶液的主峰保留时间应一致；系统适应性：拖尾因子≤2，理论塔板数≥1500，RSD≤2%。
色谱条件流速：min；色谱柱温度：35℃；检测器：紫外检测器；检测器波长：195nm；进样量：10μL；运行时间：20分钟；溶液制备流动相溶液制备流动相A：乙腈；流动相B：称取磷酸氢二钾，加入的氨水，用水定容至1L，混匀，用磷酸调节PH至；流动相A：流动相B=75:25。
蒸馏水和所用试剂均使用色谱级，流动相要用μm的有机相滤膜过滤后并超声15分钟，待用。
稀释液的配制乙腈:水=50:50，蒸馏水和乙腈均使用色谱级，流动相要用μm的有机相滤膜过滤后并超声15分钟，待用。
对照品液精确称取对照品三份(精确至置于100mL容量瓶中，用稀释液溶解并定容至刻度，摇匀待用。
供试品液精确称取烘干的供试品两份(精确至置于100mL容量瓶中，用稀释液溶解并定容至刻度，摇匀待用。
样品与对照品溶液需要通过μm有机相滤头过滤后进样。
操作步骤系统适应性按液相色谱仪检验操作规程，开启仪器并使仪器达到稳定状态后,用相同体积的进样针将三个对照品溶液按顺序依次注入色谱（定量环10μL），每个对照品分别进两针，共计六针，分别计算校正因子f1……f6，利用校正因子按下式计算得：RSD≤2%。
USP葡萄糖译文
Dextrose葡萄糖C6H12O6·H2O 198.17D-Glucose, monohydrate.D-Glucose monohydrate [5996-10-1].Anhydrous 180.16 [50-99-7].C6H12O6·H2O 分子量：198.17C6H12O6分子量：180.16» Dextrose is a sugar usually obtained by the hydrolysis of starch. It contains one molecule of water of hydration or is anhydrous.葡萄糖是淀粉水解而得到的一种糖，常以一水葡萄糖或无水葡萄糖的形式存在。
Packaging and storage— Preserve in well-closed containers.包装与贮存：本品保存在密闭容器中。
Labeling— Label it to indicate whether it is hydrous or anhydrous.注释：注明其为无水状态或水合物状态。
Identification— Add a few drops of a solution (1 in 20) to 5 mL of hot alkaline cupric tartrate TS: a copious red precipitate of cuprous oxide is formed.鉴别：加本品溶液（1比20）数滴于5mL热的碱性酒石酸铜试剂中，会形成大量红色的氧化亚铜沉淀。
Color of solution— Dissolve 25 g in water to make 50.0 mL of solution: the solution has no more color than a solution prepared by mixing 1.0 mL of cobaltous chloride CS, 3.0 mL of ferric chloride CS, and 2.0 mL of cupric sulfate CS with water to make 10 mL, and diluting 3 mL of this solution with water to 50 mL. Make the comparison by viewing the solutions downward in matched color-comparison tubes against a white surface.溶液颜色：取本品25g，用水溶解配制成50mL的溶液，该溶液颜色不得深于对照液颜色（将1.0mL氯化钴溶液、3.0mL氯化铁溶液和2.0mL硫酸铜溶液混匀后用水配制成10mL，取3mL该溶液用水稀释至50mL即得到对照液）。
氨基葡萄糖盐酸盐标准
氨基葡萄糖盐酸盐标准 Final revision by standardization team on December 10, 2020.食品添加剂氨基葡萄糖盐酸盐3结构式、分子式和相对分子量结构式：分子式：C6H13NO5.HCl相对分子量：215.634要求4.1性状产品为白色或类白色结晶粉末。
4.2理化指标应符合表1的规定。
表1应符合表2的规定。
表2除非另有说明，在分析中仅使用确认为分析纯的试剂和GB/T6682中规定的水。
5.1感官将样品置于清洁、干燥的白瓷盘中，在自然光线下，观察其色泽和状态。
5.2氨基葡萄糖盐酸盐（C6H13NO5.HCl）含量5.2.1仪器设备5.2.1.1液相色谱仪；5.2.1.2氨基柱(4.6mm×25cm，5μm)；5.2.1.310μL定量环；5.2.1.4电子分析天平(万分之一)。
5.2.2分析要求5.2.2.1鉴别：在含量测定项下记录色谱图，对照品溶液的主峰保留时间与样品溶液的主峰保留时间应一致；5.2.2.2系统适应性：拖尾因子≤2，理论塔板数≥1500，RSD≤2%。
5.2.3色谱条件5.2.3.1流速：1.5mL/min；5.2.3.2色谱柱温度：35℃；5.2.3.3检测器：紫外检测器；5.2.3.4检测器波长：195nm；5.2.3.5进样量：10μL；5.2.3.6运行时间：20分钟；5.2.4溶液制备5.2.4.1流动相溶液制备流动相A：乙腈；流动相B：称取3.5g磷酸氢二钾，加入0.25ml的氨水，用水定容至1L，混匀，用磷酸调节PH至7.5；流动相A：流动相B=75:25。
蒸馏水和所用试剂均使用色谱级，流动相要用0.45μm的有机相滤膜过滤后并超声15分钟，待用。
5.2.4.2稀释液的配制乙腈:水=50:50，蒸馏水和乙腈均使用色谱级，流动相要用0.45μm的有机相滤膜过滤后并超声15分钟，待用。
5.2.4.3对照品液精确称取对照品三份0.38g(精确至0.0002g)置于100mL容量瓶中，用稀释液溶解并定容至刻度，摇匀待用。
中国药品标准盐酸氨基葡萄糖
中国药品标准盐酸氨基葡萄糖
盐酸氨基葡萄糖，其化学式为C6H13NO5·HCl，是一种有机化合物，外观为白色或类白色结晶性粉末，无臭，味微甜，易溶于水，微溶于甲醇，不溶于乙醇等有机溶剂。
在中国，盐酸氨基葡萄糖被列入国家药品标准，通常以粉剂或片剂的形式在市场上销售。
其主要作用是治疗和预防骨关节炎，如膝关节、髋关节、脊柱等部位的关节炎。
中国药品标准对盐酸氨基葡萄糖的质量、纯度、含量、杂质限度等方面都有严格的规定，以确保其安全性和有效性。
药品生产企业必须按照国家药品标准进行生产，并经过严格的质量控制和检测，确保药品符合规定的质量标准。
需要注意的是，盐酸氨基葡萄糖属于处方药，需要在医生的指导下使用。
在使用过程中，应严格按照医生的建议和药品说明书使用，避免自行增减剂量或停药。
氨基葡萄糖(Glucosamine)补充剂选购参考
压片
Advanced Joint Health 【Glucosamine （盐酸氨基葡萄糖） +Chondroitin（软骨素）/ （750mg+100mg)】
Glucosamine （硫酸氨基葡萄糖） +Chondroitin（软骨素）/ （500mg+400mg)
Glucosamine （盐酸氨基葡萄糖） Chondroitin（软骨素） Complex/（750mg+400mg)
参考项目（二星）
加拿大卫生部许可 的天然健康产品 [标签拥有八位数 的编号（NPN）]
参考项目（三星）
产品通过 NSF/ANSI 173的 膳食补充剂认证
推荐 指数 四星
三星
三、推荐指数参考项目简介
1、【Igen】Non-GMO代表国际转基因生物（GMO）评估和通知计划。产品经过“Non-GMO Tested”认证，验证成品不含可检 测的改性遗传物质。 2、加拿大卫生部许可的天然健康产品，加拿大对天然健康产品实施审批制；从审批、生产到销售的所有环节进行严格监管。产品 进入市场前需要提交大量报告和实验数据，提供包括产品的成分名称、来源、使用剂量、功能声称及推荐使用范围等完整信息，并 获得加拿大卫生部核发的8位NPN码(Natural Products Number)才能生产和销售。在第三国生产的产品则需要进口许可证，并证明 在第三国生产的产品完全符合加拿大的良好生产规范要求。 3、USP（美国药典）的膳食补充剂验证计划，补充剂将通过严格而全面的测试和评估过程进行验证。此外，USP每年都会进行监 督；将产品从商店货架上撤下并进行测试，以帮助确保它们继续符合质量标准。 4、ISURA是加拿大唯一一家独立的非营利性天然健康产品和食品验证和认证机构。ISURA的质量管理体系经过ISO9001认证，其 实验室（通过ISO 17025认证）获得特定实验室方法的认可；帮助消费者选择符合严格标签和安全标准的优质补充剂和食品。 5、NSF（美国国家卫生基金会）根据NSF/ANSI 173对膳食补充剂进行认证，NSF/ANSI 173是测试和认证膳食补充剂的唯一美国 国家标准。作为我们认证计划的独特之处，我们进行年度审核并定期重新测试认证产品，以确保持续符合世界上最严格的膳食补充 剂质量标准。
氨糖系列标准
Glucosamine Hydrochloride(D-Glucosamine HCl; Glucosamine HCl )C 6H13NO5·HCl MW: 215.63CAS No.：66-84-2Applications: Mainly used in Medicine and Dietary Supplements. It is used for treatment and prevention of osteoarthritis in all kinds of joints all over the body, including knee joint, shoulder joint, hip joint, wrist joint, neck joint, ankle joint and the spring joint etc. It can relieve and eliminate osteoarthritis pain and swelling, improve the function of joints.Quality StandardsCOMPLY WITH USPPacking：25kg/ drum or carton, with 2 layers PE lining.Net weight 25.0kg, Gross weight 27.0kg.Ф33*H38cm Drum or L37*W37*H27cm Carton,or according to customer’s requirement.Glucosamine Sulfate Potassium Chloride(Glucosamine Sulfate 2KCl, D-Glucosamine Sulfate 2KCl)(C6H14NO5)2SO4 ·2KCl MW: 605.52CAS No.：38899-05-7Applications: Mainly used in Medicine and Dietary Supplements. It is used for treatment and prevention of osteoarthritis in all kinds of joints all over the body, including knee joint, shoulder joint, hip joint, wrist joint, neck joint, ankle joint and the spring joint etc. It can relieve and eliminate osteoarthritis pain and swelling, improve the function of joints..Quality StandardsCOMPLY WITH USPPacking：25kg/ drum or carton, with 2 layers PE lining.Net weight 25.0kg, Gross weight 27.0kg.Ф33*H38cm Drum or L37*W37*H27cm Carton,or according to customer’s requirement.Glucosamine Sulfate Sodium Chloride(Glucosamine Sulfate 2N a C l, D-Glucosamine Sulfate 2N a C l ) (C6H14NO5)2SO4 ·2NaCl MW: 573.31Applications: Mainly used in Medicine and Dietary Supplements.It is used for treatment and prevention of osteoarthritisin all kinds of joints all over the body, including knee joint, shoulder joint, hip joint, wrist joint, neck joint, ankle jointand the spring joint etc. It can relieve and eliminate osteoarthritis pain and swelling, improve the function of joints..Quality control StandardsCOMPLY WITH USPPacking：25kg/ drum or carton, with 2 layers PE lining. Net weight 25.0kg, Gross weight 27.0kg.Ф33*H38cm Drum or L37*W37*H27cm Carton,or according to customer’s requirement.Glucosamine Hydrochloride DC 95% granular(D-Glucosamine HCl; Glucosamine HCl )DC 95% granularApplications:Mainly used in Medicine and Dietary Supplements, canbe directly compressed into Tables. It is used for treatment and prevention of osteoarthritis in all kinds of joints all over the body, including knee joint, shoulder joint, hip joint, wrist joint, neck joint,ankle joint and the spring joint etc. It can relieve and eliminate osteoarthritis pain and swelling, improve the function of joints..Quality control StandardsPacking：Net weight 20.0kg, Gross weight 22.5kg.L37*W37*H37cm Carton,Glucosamine Sulfate Potassium Chloride DC 95% granular (Glucosamine Sulfate 2KCl; D-Glucosamine Sulfate 2KCl )DC 95% granularApplications:Mainly used in Medicine and Dietary Supplements, can be directly compressed into Tables. It is used for treatment and prevention of osteoarthritis in all kinds of joints all over the body, including knee joint, shoulder joint, hip joint, wrist joint, neck joint, ankle joint and the spring joint etc. It can relieve and eliminate osteoarthritis pain and swelling, improve the function of joints.Quality control StandardsPacking：20kg/ carton, with 2 layers PE lining.Net weight 20.0kg, Gross weight 22.5kg.L37*W37*H37cm Carton,Glucosamine Sulfate Sodium ChlorideDC 95% granular(Glucosamine Sulfate 2NaCl;D-Glucosamine Sulfate 2NaCl)DC 95% granularApplications:Mainly used in Medicine and Dietary Supplements, can be directly compressed into Tables. It is used for treatment and prevention of osteoarthritis in all kinds of joints all over the body, including knee joint, shoulder joint, hip joint, wrist joint, neck joint, ankle joint and the spring joint etc. It can relieve and eliminate osteoarthritis pain and swelling, improve the function of joints.Quality control StandardsPacking：20kg/ carton, with 2 layers PE lining.Net weight 20.0kg, Gross weight 22.5kg.L37*W37*H37cm Carton,。
- 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)。
盐酸氨基葡萄糖
质量标准
C6H13NO5·HCl，化学名D-葡萄糖-2-氨基-2-脱氧-盐酸盐，2-氨基-2脱氧-β-D-吡喃葡萄糖盐酸盐。
以干燥品计算，含盐酸氨基葡萄糖的量应为标示量的98.0%~102.0%。
包装和贮存：应密封避光贮存。
【鉴别】A. 本品的红外光吸收图谱应与硫酸软骨素钠对照品的图谱一致.
B. 显氯化物的鉴别反应。
C. 在含量测定项下记录的色谱图中，供试品溶液主峰的保留时间应与对照品溶液主峰的保留时间一致。
【比旋度】取本品，精密称定，用水溶解并定量稀释制成每1ml中约含25mg的溶液。
放置3小时后测定，比旋度应为+70°至+73°。
【pH】取本品，精密称定，用水溶解并定量稀释制成每1ml中约含20mg的溶液，pH值为3.0~5.0.
【干燥失重】取本品，在105℃干燥2小时，减失重量不得过1.0%。
【炽灼残渣】不得过0.1%。
【硫酸盐】取本品0.1g，溶解，与0.25ml 硫酸（浓度0.010mol/L）对照液比较，不得更深（0.24%）。
【砷盐】不得过3μg/g。
【重金属】不得过0.001%。
【含量】
磷酸盐缓冲液：量取1ml磷酸与2L水混合，并加入适量氢氧化钠调节pH至3.0。
流动相：磷酸盐缓冲液-乙腈溶液（3:2）。
超声15min后，并用0.5μm孔径的微孔滤膜过滤。
标准溶液：精密称定盐酸氨基葡萄糖标准品，制备浓度为1.0mg/ml的盐酸氨基葡萄糖对照品水溶液。
供试品溶液：精密称取100mg盐酸氨基葡萄糖至100ml容量瓶中，先加30ml水并采用机械式震动使之充分溶解，继续加水至刻度定容，摇匀。
色谱条件：
检测波长：195nm
色谱柱：C8柱（全多孔硅胶微粒键合C8官能团固定相）：4.6mm×25cm
流速：0.6ml/min
按照程序进行检测并记录图谱：氨基葡萄糖主峰拖尾因子不得大于2.0；平行进样测定结果之间的RSD%不得大于2.0%。
程序：标准溶液、供试品溶液分别进样10μl，分别记录色谱图和氨基葡萄糖主峰面积。
按照以下计算公式算出盐酸氨基葡萄糖的含量：
10000(c/w)(r u/r s)
C——代表标准溶液中盐酸氨基葡萄糖的浓度，mg/ml
W——代表供试品的质量，mg
r u——代表供试品中氨基葡萄糖的峰面积
r s——代表标准溶液中氨基葡萄糖的峰面积。