宝丹酮 Boldenone COA 企业标准-贝尔卡 低价高纯甾体激素原料药
国家食品药品监督管理局药品行政保护公告第4号(授权公告)
国家食品药品监督管理局药品行政保护公告第4号(授
权公告)
文章属性
•【制定机关】国家食品药品监督管理局(已撤销)
•【公布日期】2003.06.13
•【文号】国家食品药品监督管理局药品行政保护公告第4号
•【施行日期】2003.06.13
•【效力等级】部门规范性文件
•【时效性】现行有效
•【主题分类】药政管理
正文
国家食品药品监督管理局药品行政保护公告
（第四号授权公告）
申请人所在国：瑞士
申请人：INPHARZAMS.A
申请药品名称：
通用名：精氨洛芬颗粒(IbuprofenandArginineGranules)
商品名：司百得(Dolo-spedifen)
授权号：B-CH03061302
授权日：2003年6月13日
药品行政保护办公室对该药品的申请文件进行实质审查后，认为符合药品行政保护条件，即日起授予药品行政保护，特此公告。
国家食品药品监督管理局药品行政保护办公室
二00三年六月十三日。
国家药品监督管理局药品行政保护公告第86号(受理公告)
国家药品监督管理局药品行政保护公告第86号(受理
公告)
文章属性
•【制定机关】国家药品监督管理局
•【公布日期】2000.12.05
•【文号】国家药品监督管理局药品行政保护公告第86号
•【施行日期】2000.12.05
•【效力等级】部门规范性文件
•【时效性】现行有效
•【主题分类】药政管理
正文
国家药品监督管理局药品行政保护公告
（第86号受理公告）
申请人所在国：德国
申请人：罗氏诊断股份有限公司
申请药品名称：
通用名：Ibandronic acid
商品名：BONDRONAT 输液用浓缩液
申请号：A－DE00103007
申请日：2000年10月30日
药品行政保护办公室对该药品的申请文件初步审查合格，予以受理，即日起转为实质审查，特此公告。
国家药品监督管理局
药品行政保护办公室
二000年十二月五日。
国家食品药品监督管理局药品行政保护公告第38号(终止公告)
国家食品药品监督管理局药品行政保护公告第38号
(终止公告)
文章属性
•【制定机关】国家食品药品监督管理局(已撤销)
•【公布日期】2004.06.28
•【文号】国家食品药品监督管理局药品行政保护公告第38号
•【施行日期】2004.06.28
•【效力等级】部门规范性文件
•【时效性】现行有效
•【主题分类】药政管理
正文
国家食品药品监督管理局药品行政保护公告
（第38号终止公告）
申请人所在国：美国
申请人：杜邦公司
申请药品名称：
通用名：洛沙坦钾(Losartan Potassium)
商品名：科索亚片剂(Cozaar Tab.)
授权号：B-US96122514
授权日：1996年12月25日
该药品于1996年12月25日在中国获得的药品行政保护，已于2004年6月25日期限届满。
特此公告。
国家食品药品监督管理局药品行政保护办公室
二00四年六月二十八日。
国家药品监督管理局药品行政保护公告第143号(授权公告)
国家药品监督管理局药品行政保护公告第143号(授权
公告)
文章属性
•【制定机关】国家药品监督管理局
•【公布日期】2002.03.13
•【文号】国家药品监督管理局药品行政保护公告第143号
•【施行日期】2002.03.13
•【效力等级】部门规范性文件
•【时效性】现行有效
•【主题分类】药政管理
正文
国家药品监督管理局药品行政保护公告
（第143号授权公告）
申请人所在国：芬兰
申请人：奥利安公司
申请药品名称：
通用名：枸橼酸托瑞米芬(Toremifene citrate)
商品名：法乐通(Fareston)片剂
授权号：B-FI02031302
授权日：2002年3月13日
药品行政保护办公室对该药品的申请文件进行实质审查后，认为符合行政保护条件，即日起授予行政保护。
国家药品监督管理局药品行政保护办公室
二00二年三月十三日。
国家药品监督管理局药品行政保护公告第100号(终止公告)
国家药品监督管理局药品行政保护公告第100号(终止
公告)
文章属性
•【制定机关】国家药品监督管理局
•【公布日期】2001.04.05
•【文号】国家药品监督管理局药品行政保护公告第100号
•【施行日期】2001.04.05
•【效力等级】部门规范性文件
•【时效性】现行有效
•【主题分类】药政管理
正文
国家药品监督管理局药品行政保护公告
（第100号终止公告）
申请人所在国：瑞士
申请人：山德士制药有限公司
申请药品名称：
通用名：奥曲肽(Octreotide)复方注射剂
商品名：善得定(Sandostatin)注射剂
授权号：B－CH93092302
授权日：1993年9月23日
该药品于1993年9月23日获得在中国的药品行政保护，保护期七年半，于2001年3月23日到期，特此公告。
国家药品监督管理局药品行政保护办公室
二00一年四月五日。
康力龙 司坦唑醇 Stanozolol USP35标准-贝尔卡 低价高纯甾体激素原料药
4684Stannous / Official Monographs USP 35nous fluoride in each g of Gel as determined in the Assay, andis not less than 90.0% of the quantity, in mg, of total tin in Stanozololeach g of Gel as determined in the test for Total tin content.Total tin content—Potassium chloride solution—Dissolve 1.91 g of potassiumchloride in water to make 100 mL of solution.Tin stock standard solution—Transfer 1.000 g of tin, accu-rately weighed, to a 1000-mL volumetric flask, add 200 mL ofhydrochloric acid, and swirl to dissolve. Add 200 mL of water,allow to cool, dilute with water to volume, and mix.C21H32N2O328.49Standard preparations—Transfer 5.0, 10.0, and 15.0 mL of2′H-Androst-2-eno[3,2-c]pyrazol-17-ol, 17-methyl-, (5α,17β)-. Tin stock standard solution to separate 100-mL volumetric flasks,17-Methyl-2′H-5α-androst-2-eno[3,2-c]pyrazol-17β-ol [10418-add 1.0 mL of Potassium chloride solution to each flask, dilute03-8].with water to volume, and mix. The Standard preparations con-» Stanozolol contains not less than 98.0 percent tain, respectively, 50.0, 100.0, and 150.0 µg of tin per mL.and not more than 100.5 percent of C21H32N2O, Test preparation—Transfer an accurately weighed quantity ofGel, equivalent to about 132 mg of stannous fluoride, to a calculated on the dried basis.plastic beaker. Add 80 mL of water and 20 mL of hydrochloricPackaging and storage—Preserve in tight, light-resistant acid, and mix. Transfer this mixture to a 1000-mL volumetriccontainers.flask, add 10.0 mL of Potassium chloride solution, dilute withwater to volume, and mix.USP Reference standards 〈11〉—Blank—Add 2 mL of hydrochloric acid and 1.0 mL of Potas-USP Stanozolol RSsium chloride solution to a 100-mL volumetric flask, dilute withIdentification—water to volume, and mix.A: Infrared Absorption 〈197K〉.Procedure—Concomitantly determine the absorbance of theStandard preparations, the Test preparation, and the Blank at the B: Ultraviolet Absorption 〈197U〉—tin emission line of 235.5 nm, with an atomic absorption spec-Solution: 50 µg per mL.trophotometer (see Spectrophotometry and Light-scattering Medium: alcohol.〈851〉) equipped with a tin hollow-cathode lamp and a nitrous Absorptivities at 224 nm, calculated on the dried basis, do oxide-acetylene oxidizing flame, using water to adjust the in-not differ by more than 3.0%.strument to zero. Aspirate water into the spectrophotometerSpecific rotation 〈781S〉: between +34° and +40°.before and after each Standard preparation, the Test preparation,Test solution: 10 mg per mL, in chloroform.and the Blank. Correct the absorbances of the Standard prepara-tions and the Test preparation by subtracting the absorbance of Loss on drying 〈731〉—Dry it at a pressure not exceeding 5 the Blank. Plot the corrected absorbances of the Standard prepa-mm of mercury at 100° to constant weight: it loses not more rations versus concentration, in µg per mL, of tin, and draw the than 1.0% of its weight.straight line best fitting the three plotted points. From the Chromatographic purity—graph so obtained, determine the concentration, in µg per mL,Standard dilutions—Dissolve an accurately weighed quantity of tin in the Test preparation. Calculate the quantity, in mg, of of USP Stanozolol RS in a mixture of chloroform and methanol tin in each g of Gel taken by the formula:(9:1) to obtain a solution having a known concentration ofabout 20 mg per mL. Dilute this solution with the same me-C/Wdium to obtain Standard dilutions having known concentrationsof about 50, 100, 200, and 400 µg per mL, respectively.in which C is the concentration, in µg per mL, of tin in the TestProcedure—Score a 20- × 20-cm thin-layer chromatographic preparation; and W is the quantity, in g, of Gel taken to prepareplate coated with a 0.25-mm layer of chromatographic silica gel the Test preparation. Use this value to calculate the percentagemixture (binder-free) into channels 10 mm wide. Apply 10-µL of stannous ion in the test for Stannous ion content.portions, in two 5-µL increments, of a test solution prepared by Assay—[NOTE—Store all solutions, except the Buffer solution, indissolving Stanozolol in a mixture of chloroform and methanol plastic containers.](9:1) to obtain a solution containing about 20 mg per mL, and Buffer solution and Standard preparations—Prepare as directed of each of the four Standard dilutions in the center of the chan-in the Assay under Sodium Fluoride Oral Solution.nels at points about 2.5 cm from one edge of the plate. De-Assay preparation—Transfer an accurately weighed quantity velop the plate in a suitable chamber, lined with filter paperof Gel, equivalent to about 8 mg of stannous fluoride, to a 100-and previously equilibrated with 200 mL of a mixture of chloro-mL volumetric flask, dilute with water to volume, and mix.form and methanol (188:12), for 15 minutes, taking care to Procedure—Proceed as directed for Procedure in the Assay ensure that the filter paper has been wetted completely with under Sodium Fluoride Oral Solution. Calculate the quantity, in the solvent mixture. Allow the plate to develop until the solvent mg, of stannous fluoride (SnF2) in each g of the Gel taken by front has moved about 15 cm above the line of application. the formula:Remove the plate, and allow the solvent to evaporate com-pletely. Spray it with 20% sulfuric acid, and heat in an oven at (156.71/38.0)(C/10W)100° for 15 minutes. Examine the plate under long-wavelengthUV light: the channel for the test solution exhibits its principal in which 156.71 is the molecular weight of stannous fluoride,spot at the same R F value as the spots for the Standard dilutions.38.0 is twice the atomic weight of fluorine; C is the determined Estimate the concentration of any spots in the channel for the concentration, in µg per mL, of fluoride in the Assay prepara-test solution, other than the principal spot, by comparison with tion; and W is the weight, in g, of the Gel taken.the spots from the Standard dilutions. The spots from the 50-,100-, 200-, and 400-µg-per-mL dilutions correspond to 0.25%,0.5%, 1.0%, and 2.0% of chromatographic impurities, respec-tively, and the sum of the chromatographic impurities in thetest solution is not greater than 2.0%.Assay—Dissolve about 700 mg of Stanozolol, accuratelyweighed, in 50 mL of glacial acetic acid, add 1 drop of crystalviolet TS, and titrate with 0.1 N perchloric acid VS to a greenUSP 35Official Monographs / Starch 4685endpoint. Perform a blank determination, and make any neces-medium-porosity filter paper, taking precautions to minimize sary correction. Each mL of 0.1 N perchloric acid is equivalent evaporation, discard the first 5 mL of the filtrate, and proceed to 32.85 mg of C 21H 32N 2O.as directed for Assay preparations in the Assay , beginning with “Transfer 5.0 mL of the filtrate.”Assay—[NOTE —Maintain the acid concentration at a uniform level in the solutions being compared spectrophotometrically;the same acidic alcohol solution is to be used throughout this Stanozolol Tabletsprocedure.]Standard preparations—Dissolve a suitable quantity of USP » Stanozolol Tablets contain not less than 90.0Stanozolol RS, accurately weighed, in alcohol, and dilute quan-percent and not more than 110.0 percent of the titatively and stepwise with alcohol, if necessary, to obtain a stock solution having a known concentration of about 80 µg labeled amount of stanozolol (C 21H 32N 2O).per mL. Transfer 5.0 mL of this stock solution to a 10-mL volu-Packaging and storage—Preserve in tight, light-resistant metric flask, dilute with alcohol to volume, and mix to prepare containers.the Neutral standard preparation. Transfer another 5.0-mL por-tion of the stock solution to a second 10-mL volumetric flask,USP Reference standards 〈11〉—dilute with acidic alcohol (1.5 mL of hydrochloric acid in 100USP Stanozolol RSmL of alcohol) to volume, and mix to prepare the Acidic stan-Identification—Boil an amount of powdered Tablets, equiva-dard preparation. The concentration of USP Stanozolol RS in the lent to about 2 mg of stanozolol, with 5 mL of benzene, filter,Standard preparations is about 40 µg per mL.and evaporate on a steam bath to dryness. Add 3 mL of p -Assay preparations—Weigh and finely powder not less than dimethylaminobenzaldehyde TS to the residue: a yellow color 20 Tablets. Transfer an accurately weighed portion of the pow-develops, which exhibits a green fluorescence under long-wave-der, equivalent to about 4 mg of stanozolol, to a 50-mL volu-length UV light.metric flask, add about 25 mL of alcohol, and heat on a steam Dissolution 〈711〉—bath, with frequent swirling, for 15 minutes. Cool, dilute with alcohol to volume, mix, filter through medium-porosity filter Medium: 0.1 N hydrochloric acid; 500 mL.paper, taking precautions to minimize evaporation, and discard Apparatus 2: 50 rpm.the first 10 mL of the filtrate. Transfer 5.0 mL of the filtrate to a Time: 45 minutes.10-mL volumetric flask, dilute with alcohol to volume, and mix Determine the amount of C 21H 32N 2O dissolved by employing to prepare the Neutral assay preparation. Transfer another 5.0-the following method.mL portion of the filtrate to a second 10-mL volumetric flask,Bromocresol purple solution—Mix 1.0 g of bromocresol purple dilute with acidic alcohol (1.5 mL of hydrochloric acid in 100with 1000 mL of dilute glacial acetic acid (1 in 50), and filter if mL of alcohol) to volume, and mix to prepare the Acidic assay necessary to obtain a clear solution.preparation.Standard preparations—[NOTE —Prepare Standard preparations Procedure—Concomitantly determine the absorbances of the on the day of use.] Transfer about 50 mg of USP Stanozolol RS,acidic alcohol solution, the Acidic standard preparation , and the accurately weighed, to a 50-mL volumetric flask, add 15.0 mL Acidic assay preparation in 1-cm cells at the wavelength of maxi-of methanol, and mix to dissolve. Add 5.0 mL of 1.0 N hydro-mum absorbance at about 235 nm, with a suitable spectropho-chloric acid, dilute with water to volume, and mix. Transfer 5.0tometer, using alcohol, the Neutral standard preparation , and mL of the resulting solution to a 200-mL volumetric flask, dilute the Neutral assay preparation , respectively, as the blanks. Calcu-with Dissolution Medium to volume, and mix. Separately pipet late the quantity, in mg, of C 21H 32N 2O in the portion of Tablets 2-mL, 4-mL, and 6-mL portions of the solution into three 60-taken by the formula:mL separators, add accurately measured volumes of Dissolution Medium to adjust the volumes in each to 25.0 mL, and pipet 250.1C (A U − A O )/(A S − A O )mL of Dissolution Medium into a fourth 60-mL separator.in which C is the concentration, in µg per mL, of USP Sta-Procedure—Pipet 25 mL of a filtered portion of the solution nozolol RS in the Standard preparations; and A U , A S , and A O are under test into a 60-mL separator. To this separator and to each the absorbances of the Acidic assay preparation , the Acidic stan-of the four separators containing Standard preparations add 1.0dard preparation , and the acidic alcohol solution, respectively.mL of Bromocresol purple solution and 10.0 mL of chloroform.Insert the stopper in each, shake gently for 1 minute, allow the phases to separate, and swirl if necessary to break up emul-sions. Transfer the lower chloroform layers to separate 50-mL centrifuge tubes, insert the glass stoppers, and centrifuge for 5Topical Starchminutes to clarify the solutions. Concomitantly determine the absorbances of the solutions obtained from the solution under » Topical Starch consists of the granules sepa-test and from the Standard preparation in 1-cm cells, at the wavelength of maximum absorbance at about 420 nm, with a rated from the mature grain of corn [Zea mays suitable spectrophotometer, using chloroform as the blank.Linn´e (Fam. Gramineae)].Construct a standard plot of absorbances versus the concentra-tions of the solutions from the Standard preparations. From the Packaging and storage—Preserve in well-closed containers.plot so obtained, determine the amount of C 21H 32N 2O dissolved Botanic characteristics—Polygonal, rounded or spheroidal in the solution from the solution under test.granules up to about 35 µm in diameter and usually having a Tolerances—Not less than 75% (Q) of the labeled amount of circular or several-rayed central cleft.C 21H 32N 2O is dissolved in 45 minutes.Identification—Uniformity of dosage units 〈905〉—[NOTE —Maintain the acid A: Prepare a smooth mixture of 1g of it with 2 mL of cold concentration at a uniform level in the solutions being com-water, stir it into 15 mL of boiling water, boil gently for 2pared spectrophotometrically; the same acidic alcohol solution minutes, and cool: a translucent, whitish jelly is produced.is to be used throughout this procedure. Also, take precautions B: A water slurry of it is colored reddish violet to deep blue throughout this procedure to minimize evaporation.] Transfer 1by iodine TS.Tablet to a 25-mL volumetric flask, add 0.5 mL of water, and Microbial enumeration tests 〈61〉 and Tests for specified shake to disintegrate. Add about 20 mL of alcohol, heat on a microorganisms 〈62〉—The total aerobic microbial count doessteam bath, with occasional swirling, for 10 to 15 minutes, then cool, dilute with alcohol to volume, and mix. Filter through。
仿制药参比制剂目录(第1-13批)
GlaxoSmithKline
美国橙皮书
1-5
头孢呋辛酯片
Cefuroxime Axetil Tablets/Zinacef
按头孢呋辛(C16H16N4O8S)计0.25g
片剂
Glaxo口
1-6
辛伐他汀片
Simvastatin Tablets/Zocor
附件
仿制药参比制剂目录（第一批）
序号
药品通用名称
英文名称/商品名
规格
剂型
持证商
备注1
备注2
1-1
盐酸胺碘酮片
Amiodarone Hydrochloride Tablets/Cordarone
0.2g
片剂
Sanofi-Aventis France
原研进口
1-2
阿卡波糖片
Acarbose Tablets/Glucobay
10mg
片剂
Merck Sharp & Dohme (Australia) Pty. Ltd.
原研进口
1-7
辛伐他汀片
Simvastatin Tablets/Zocor
20mg
片剂
Merck Sharp & Dohme B.V.
原研进口
1-8
盐酸氨溴索片
Ambroxol Hydrochloride Tablets/Mucosolvan
0.5mg
片剂（舌下片）
Pfizer INC
原研进口
适用于硝酸甘油舌下片和舌下含服的硝酸甘油片
1-30
克拉霉素片
50mg
片剂
Bayer Vital GmbH
原研进口
1-3
尼莫地平片
地屈孕酮 企业标准
地屈孕酮企业标准背景介绍：地屈孕酮，又称环化孕酮，是一种重要的合成荷尔蒙，具有广泛的临床应用，包括抗炎、抗菌、止血等方面。
因其独特的化学结构，地屈孕酮在医疗领域中得到了广泛的应用，但市场上也出现了不少劣质地屈孕酮产品，使得消费者的利益得不到保障。
为了加强地屈孕酮产品的质量管理，保障消费者的健康和安全，本企业特制定此地屈孕酮企业标准。
一、产品名称：地屈孕酮二、产品外观：为白色或几乎白色的结晶或结晶性粉末三、产品质量指标：项目指标标准外观符合产品外观要求纯度≥99%水分≤0.5%灰分≤0.1%重金属≤20μg/g差向异构体≤0.2%单一未知杂质≤0.1%总杂质≤1.0%微生物限度符合国家药品法规要求四、检测方法：1、纯度：采用高效液相色谱法测定。
2、水分：采用卡尔-费雪法测定。
3、灰分：采用硫酸钠加热干燥法测定。
4、重金属：采用原子吸收光谱法测定。
5、差向异构体：采用红外分光光谱法测定。
6、单一未知杂质：采用气相色谱法测定。
7、总杂质：采用高效液相色谱法测定。
8、微生物限度：采用国家药典2015年版测定。
五、包装标识：1、标准包装：内衬双层聚乙烯塑料袋，外装纤维板桶或纤维板盒。
2、标识要求：应标注产品名称、纯度、生产日期、保质期、批号等信息。
六、贮存运输：1、贮存时应避免与有毒有害物质接触。
2、应贮存在阴凉、干燥、通风、无异味的库房中，避光、避潮、避水。
3、运输应轻装轻卸，防止挤压、碰撞。
七、用途：地屈孕酮主要用于医药领域，作为合成荷尔蒙，广泛应用于抗炎、抗菌、止血等方面。
八、产品说明：本标准执行自发布之日起生效，企业应按照本标准要求进行生产和质量控制，确保产品质量符合本标准规定。
企业需及时更新生产工艺和质量标准，并定期对产品进行检测和评价，确保产品质量持续稳定。
结论：本企业自主制定了地屈孕酮企业标准，以规范产品质量及标准，提高产品可靠性和稳定性，确保消费者健康与安全。
企业应按照本标准要求进行生产和质量控制，不断完善和提高产品质量标准，做出更多贡献。
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质量分析单
品名 宝丹酮 Cas.No 846-48-0
生产日期 2014-06-20 报告日期 2014-06-21 生产批号 20140620 有效日期 2016-06
批量
14GT-0621BB
检验标准
本品符合企业标准
检验员：罗欣 核验员：梁辉 质检科长：高进
检验项目
检验标准
检验结果
性状 白色结晶或结晶性粉末 白色结晶性粉末 测定法 98.0%
98.80
熔点 166~173°C 166.5~170.0°C 比旋度 +23~+27° +25.1° 干燥失重 0.5% 0.27% 有关物质 2.0%
＜2.0%
溶剂残留 丙酮：100ppm 的最大 甲醇：100ppm 的最大 吡啶：100ppm 的最大 <100PPm <100PPm <100PPm
结论
经检验，本品符合企业标准
武汉贝尔卡生物医药有限公司 Wuhan Biocar Bio-Pharm Co., Ltd 电话： 传真： 网址： 地址：武汉市东湖开发区高新大道858号 光谷生物城生物医药园。