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药典标准品和杂质标准品

药典标准品是指由国家药品监督管理局认定并公布的、用于药物质量控制的标准物质,其纯度、含量及稳定性等特性已经过严格验证。药典标准品在确保药品质量和安全性方面起着至关重要的作用。

杂质标准品则是指用于检测药物中可能存在的各种类型杂质的化学试剂或混合物。与药典标准品不同的是,杂质标准品不一定是单一化合物的标准品,它们可以是特定类型的杂质或是代表性的杂质混合物,旨在帮助制药企业进行质量控制和开发更为严格的生产工艺。

两者在药品生产和监管中都发挥着重要作用:药典标准品用于检测药物的主要成分是否符合规定的含量范围;而杂质标准品则有助于识别、定量分析并降低潜在的有害杂质,从而确保最终产品的安全性和有效性。在研发新药或改进现有药物的过程中,正确使用这些标准品可以有效提高产品质量和安全性评估水平。

中文名称 英文名称 CAS号 化学式
达格列净杂质10 (3R,4S,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-2,3,4,5-tetraol 461432-27-9 C21H25ClO7
达格列净杂质 (2R,3S,4R,5R)-2,3,4-tris(trimethylsilyloxy)-5-[(trimethylsilyloxy)methyl]cyclohexanone 639852-30-5 C19H44O5Si4
达克罗宁杂质3 trans-1,2-di(4-butoxy)ethylene 14146-86-2 C24H28O4
达克罗宁杂质2 1-(4-Butoxyphenyl)-2-propen-1-one 66536-15-0 C13H16O2
辛酸氨基甲酸乙酯N-氧化物 (+)-apovincaminic acid N-oxide ethyl ester 109741-24-4 C22H26N2O3
辛基奥利司他 Octyl Orlistat 1243011-56-4 C31H57NO5
辛可卡因EP杂质C 2-Hydroxy-chinolin-4-carbonsaeure-diethylethylendiamid 87864-08-2 C16H21N3O2
辛伐他汀杂质B simvastatin acetate 145576-25-6 C27H40O6
辛伐他汀4'-甲基醚 (1S,3R,7S,8S,8aR)-8-{2-[(2R,4S)-4-Methoxy-6-oxooxan-2-yl]ethyl}-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl 2,2-dimethylbutanoate 864357-88-0 C26H40O5
辅酶 M dimesna 45127-11-5 C4H10O6S4
轧特醇杂质C 11-oxo-1,4,7,10-tetraazabicyclo[8.2.2]tetradecane-4,7-diacetic acid 220182-19-4 C14H24N4O5
车前苷 plantaginin 26046-94-6 C21H20O11
超强辣素 resiniferatoxin 57444-62-9 C37H40O9
赶黄草苷B 1-Propanone, 1-[4-[[4,6-O-[[(1S)-4,4',5,5',6,6'-hexahydroxy[1,1'-biphenyl]-2,2'-diyl]dicarbonyl]-beta-D-glucopyranosyl]oxy]-2,6-dihydroxyphenyl]-3-phenyl- 271579-12-5 C35H30O17
赛乐西帕杂质3 2,3-dichloro-5,6-diphenylpyrazine 57038-62-7 C16H10Cl2N2
赛乐西帕杂质1 N-isopropyl-4-hydroxybutyramide 42042-66-0 C7H15NO2
赛乐西帕中间体 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}acetic acid tert-butyl ester 475084-96-9 C29H37N3O3
赖诺普利EP杂质D (2S)-2-[(3S,8aR)-3-(4-butylamino)-1,4-dioxohexahydropyrrole[1,2-a]pyrazine-2(1H)-yl]-4-phenylbutyric acid 219677-82-4 C21H29N3O4
贝那普利相关物质A Benazepril hydrochloride, (R,R)- 215447-89-5 C24H29ClN2O5
贝那普利相关化合物 G 1-ethoxycarbonylmethyl-3S-(1S-ethoxycarbonyl-3-phenylpropylamino)-2,3,4,5-tetrahydro-1H-[1]benzazepin-2-one 103129-58-4 C26H32N2O5
贝那普利杂质B 1-carboxymethyl-3(S)-(1(S)-ethoxycarbonyl-3-phenylpropylamino)-2,3,4,5-tetrahydro-1H[1]-benzazepine-2-one 98626-50-7 C24H28N2O5
贝那普利拉 benazeprilate 86541-78-8 C22H24N2O5
贝美前列素杂质 (Z)-7-((1R,2R,3R,5S)-3,5-dihydroxy-2-((R,E)-3-hydroxy-5-phenylpent-1-en-1-yl)cyclopentyl)hept-5-enoic acid 41639-71-8 C23H32O5
贝派度酸杂质 2,2,8,8-Tetramethylnonanedioic acid 30313-67-8 C13H24O4
谷胱甘肽-(甘氨酸-13C2,15N1) [<sup>13</sup>C<sub>2</sub><sup>15</sup>N]-glutathione 815610-65-2 C10H17N3O6S
诺氟沙星杂质2 6-fluoro-7-amino-1-ethyl-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid 75001-63-7 C12H11FN2O3
观音莲明 lysicamine 15444-20-9 C18H13NO3
西酞普兰羧酸杂质 1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carboxylic acid 440121-09-5 C20H22FNO3
西酞普兰杂质B 3-Hydroxy Citalopram Oxalate 1332724-03-4 C22H23FN2O6
西酞普兰二甲氨基丁酮 5-Dimethylaminobutyryl citalopram 1329745-98-3 C25H33FN2O2
西那卡特杂质J (R)-(1-naphthalen-1-ylethyl)-N,N-bis[3-(3-trifluoromethylphenyl)propyl]amine 1271930-15-4 C32H31F6N
西那卡塞杂质4 (2E)-N-[(1R)-1-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]prop-2-en-1-amine 955373-56-5 C22H20F3N
西那卡塞杂质2 (R)-α-methyl-N-[3-[3-(trifluoromethyl)phenyl]methyl]-1-naphthalenemethaneamine 1229512-52-0 C20H18F3N
西罗莫司异构体C rapamycin 150821-39-9 C51H79NO13
西罗多辛脱氢杂质 Dehydro silodosin 175870-21-0 C25H30F3N3O4
西维来司他杂质1 (2-aminobenzoylamino)acetic acid ethyl ester 5973-34-2 C11H14N2O3
西替利嗪氧化物 cetirizine-N-oxide 1076199-80-8 C21H25ClN2O4
西替利嗪杂质E 2-(2-(2-(4-((4-Chlorophenyl)phenylmethyl)piperazin-1-yl)ethoxy)ethoxy)acetic acid 682323-77-9 C23H29ClN2O4
西替利嗪杂质C 2-[2-[4-[(2-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]-acetic acid 83881-59-8 C21H25ClN2O3
西替利嗪杂质A (2-{4-[(4-chlorophenyl)phenylmethyl]piperazin-1-yl}ethoxy)acetic acid ethyl ester 246870-46-2 C23H29ClN2O3
西替利嗪杂质10 3-Chlorocetirizine 1232460-31-9 C21H25ClN2O3
西奥骨化醇 seocalcitol 134404-52-7 C30H46O3
西地那非杂质C 5-(2-hydroxy-5-((4-methylpiperazin-1-yl)sulfonyl)phenyl)-1-methyl-3-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one 139755-91-2 C20H26N6O4S
西地那非-d3 Sildenafil-d3 1126745-90-1 C22H30N6O4S
西咪替丁EP杂质F <i>N</i>-cyano-<i>N'</i>,<i>N''</i>-bis-[2-(5-methyl-1(3)<i>H</i>-imidazol-4-ylmethylsulfanyl)-ethyl]-guanidine 55272-86-1 C16H24N8S2
西司他丁钠 81129-83-1 C16H26N2NaO5S
西他列汀脱氟杂质4 (3R)-3-[(1,1-dimethylethoxycarbonyl)amino]-4-(2,5-difluorophenyl)butanoic acid 486459-98-7 C15H19F2NO4
西他列汀脱氟杂质3 (R)-3-((tert-Butoxycarbonyl)amino)-4-(2,4-difluorophenyl)butanoic acid 851307-12-5 C15H19F2NO4
西他列汀杂质9 (Z)-methyl 3-acetamido-4-(2,4,5-trifluorophenyl) but-2-enoate 1234321-81-3 C13H12F3NO3
西他列汀杂质28 Sitagliptin Impurity B 898543-70-9 C32H25F12N9O2