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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 结构式图片
(3aS-顺式)-1,3-二苄基四氢-1H-噻吩并[3,4-d]咪唑-2,4-二酮 (3aS,6aR)-1,3-dibenzyltetrahydro-1H-thieno[3,4-d]imidazole-2,4-dione 33607-57-7 C19H18N2O2S
(3aS-顺式)-1,3-二苄基四氢-1H-噻吩并[3,4-d]咪唑-2,4-二酮
(3aS,4R,5S,6aR)-(+)-六氢-5-羟基-4-(羟甲基)-2H-环戊并[b]呋喃-2-酮 (+)-corey lactone diol 76704-05-7 C8H12O4
(3aS,4R,5S,6aR)-(+)-六氢-5-羟基-4-(羟甲基)-2H-环戊并[b]呋喃-2-酮
(3Z,14aR,14bR)-4,6-二(乙酰氧基)-3-亚乙基-2,3,4,5,6,7,9,11,13,14,14a,14b-十二氢-5,6,12-三甲基-2,7-二氧代-[1,6]二氧杂环十二碳六烯并[2,3,4-gh]吡咯里嗪鎓 Ligularine 34429-54-4 C23H32NO9+
(3Z,14aR,14bR)-4,6-二(乙酰氧基)-3-亚乙基-2,3,4,5,6,7,9,11,13,14,14a,14b-十二氢-5,6,12-三甲基-2,7-二氧代-[1,6]二氧杂环十二碳六烯并[2,3,4-gh]吡咯里嗪鎓
(3S,5S,8R,9S,10S,13S,14S)-10,13-二甲基-17-(吡啶-3-基)-2 3β-acetoxy-17-(3-pyridyl)-5α-androst-16-ene 219843-76-2 C26H35NO2
(3S,5S,8R,9S,10S,13S,14S)-10,13-二甲基-17-(吡啶-3-基)-2
(3S,5R,6E)-7-[2-环丙基-4-(4-氟苯基)-3-喹啉基]-3,5-二羟基-6-庚烯酸 (3S,5R,E)-7-(2-Cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid 254452-86-3 C25H24FNO4
(3S,5R,6E)-7-[2-环丙基-4-(4-氟苯基)-3-喹啉基]-3,5-二羟基-6-庚烯酸
(3S,5R)-6-氰基-3,5-二羟基-己酸叔-丁酯 (3S,5R)-tert-butyl 6-cyano-3,5-dihydroxyhexanoate 186508-94-1 C11H19NO4
(3S,5R)-6-氰基-3,5-二羟基-己酸叔-丁酯
(3S,4S)-4-甲基-3-(甲基-7H-吡咯并[2,3-d]嘧啶-4-氨基)-beta-氧代-1-哌啶丙腈 tofacitinib 1092578-47-6 C16H20N6O
(3S,4S)-4-甲基-3-(甲基-7H-吡咯并[2,3-d]嘧啶-4-氨基)-beta-氧代-1-哌啶丙腈
(3S,4S)-3-己基-4-[(S)-2-羟基十三烷基]-2-氧杂环丁酮 (3S,4S)-3-hexyl-4-[(2S)-2-hydroxytridecyl]oxetan-2-one 68711-40-0 C22H42O3
(3S,4S)-3-己基-4-[(S)-2-羟基十三烷基]-2-氧杂环丁酮
(3S,4S)-3-己基-4-[(2R)-2-羟基十三烷基]-2-氧杂环丁酮 (3S,4S)-3-hexyl-4-[(R)-2-hydroxytridecyl]-2-oxetanone 104872-06-2 C22H42O3
(3S,4S)-3-己基-4-[(2R)-2-羟基十三烷基]-2-氧杂环丁酮
(3S,4S)-1-苄基-N,4-二甲基哌啶-3-胺 (3S,4S)-1-benzyl-N,4-dimethylpiperidin-3-amine 1354621-59-2 C14H22N2
(3S,4S)-1-苄基-N,4-二甲基哌啶-3-胺
(3S,4R)-4-甲基-3-(甲基-7H-吡咯并[2,3-d]嘧啶-4-氨基)-beta-氧代-1-哌啶丙腈 3-((3S,4R)-3-((1H-Indol-4-yl)(methyl)amino)-4-methylpiperidin-1-yl)-3-oxopropan-enitrile 1092578-48-7 C16H20N6O
(3S,4R)-4-甲基-3-(甲基-7H-吡咯并[2,3-d]嘧啶-4-氨基)-beta-氧代-1-哌啶丙腈
(3S,4R)-3-[(1,3-苯并二氧杂环戊烯-5-基氧基)甲基]-1-甲基-4-苯基哌啶 (-)-trans-1-methyl-3-(3,4-methylenedioxyphenoxymethyl)-4-phenylpiperidine 324023-99-6 C20H23NO3
(3S,4R)-3-[(1,3-苯并二氧杂环戊烯-5-基氧基)甲基]-1-甲基-4-苯基哌啶
(3S,4R)-3-[(1,3-苯并二氧戊环-5-基氧基)甲基]-1-苄基-4-(4-氟苯基)哌啶 (-)-N-benzyl paroxetine 105813-14-7 C26H26FNO3
(3S,4R)-3-[(1,3-苯并二氧戊环-5-基氧基)甲基]-1-苄基-4-(4-氟苯基)哌啶
(3S)-N-甲基-3-(2-甲基苯氧基)-3-苯基丙烷-1-胺 (S)-N-methyl-3-(2-methylphenoxy)-3-phenyl-1-propanamine 105314-53-2 C17H21NO
(3S)-N-甲基-3-(2-甲基苯氧基)-3-苯基丙烷-1-胺
(3S)-N-[[(1S)-1,2,3,4-四氢-1-萘基]甲基]-1-氮杂双环[2.2.2]辛烷-3-胺 (S)-N-(((S)-1,2,3,4-tetrahydronaphthalene-1-yl)methyl)quinuclidine-3-amine 177793-80-5 C18H26N2
(3S)-N-[[(1S)-1,2,3,4-四氢-1-萘基]甲基]-1-氮杂双环[2.2.2]辛烷-3-胺
(3S)-6,6-二溴-2,2-二甲基青霉烷-3-羧酸 1,1-二氧化物 6,6-dibromopenicillanic acid-1,1-dioxide 76646-91-8 C8H9Br2NO5S
(3S)-6,6-二溴-2,2-二甲基青霉烷-3-羧酸 1,1-二氧化物
(3S)-3-[3-[(1E)-2-(7-氯-2-喹啉基)乙烯基]苯基]-4,5-二氢-2-苯并氧杂卓-1(3H)-酮 (3S)-3-[3-[(E)-2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-4,5-dihydro-3H-benzo[c]oxepin-1-one 1100617-38-6 C27H20ClNO2
(3S)-3-[3-[(1E)-2-(7-氯-2-喹啉基)乙烯基]苯基]-4,5-二氢-2-苯并氧杂卓-1(3H)-酮
(3S)-10-氟-2,3-二氢-3-甲基-7-氧代-7H-吡啶并[1,2,3-de]-1,4-苯并恶嗪-6-羧酸 (3S)-10-Fluoro-2,3-dihydro-3-methyl-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic Acid 117620-84-5 C13H10FNO4
(3S)-10-氟-2,3-二氢-3-甲基-7-氧代-7H-吡啶并[1,2,3-de]-1,4-苯并恶嗪-6-羧酸
(3R,8S,9S,12R)-阿扎那韦 (3S,8R,9R,12S)-Atazanavir 1292296-11-7 C38H52N6O7
(3R,8S,9S,12R)-阿扎那韦
(3R,5S)-氟伐他汀钠盐 fluvastatin sodium 94061-80-0 C24H25FNO4*Na
(3R,5S)-氟伐他汀钠盐
(3R,5S)-6-氯-3,5-二羟基己酸叔丁酯 tert-butyl (3R,5S)-6-chloro-3,5-dihydroxyhexanoate 154026-93-4 C10H19ClO4
(3R,5S)-6-氯-3,5-二羟基己酸叔丁酯
(3R,5S)-5-[(联苯-4-基)甲基]-3-甲基吡咯烷-2-酮 (3R,5S)-5-([1,1'-biphenyl]-4-ylmethyl)-3-methylpyrrolidin-2-one 1038924-70-7 C18H19NO
(3R,5S)-5-[(联苯-4-基)甲基]-3-甲基吡咯烷-2-酮
(3R,5R,6E)-7-[2-环丙基-4-(4-氟苯基)-3-喹啉基]-3,5-二羟基-6-庚烯酸 (3R,5R,E)-7-(2-Cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid 769908-13-6 C25H24FNO4
(3R,5R,6E)-7-[2-环丙基-4-(4-氟苯基)-3-喹啉基]-3,5-二羟基-6-庚烯酸
(3R,5R)-7-[(1S,2S,6R,8S,8aR)-8-(2,2-二甲基丁酰氧基)-1,2,6,7,8,8a-六氢-2,6-二甲基-1-萘基]-3,5-二羟基庚酸铵 simvastatin ammonium salt 139893-43-9 C25H40O6*H3N
(3R,5R)-7-[(1S,2S,6R,8S,8aR)-8-(2,2-二甲基丁酰氧基)-1,2,6,7,8,8a-六氢-2,6-二甲基-1-萘基]-3,5-二羟基庚酸铵
(3R,5R)-6-氰基-3,5-二羟基己酸叔丁酯 t-butyl 6-cyano-(3R,5R)-dihydroxyhexanoate 125971-93-9 C11H19NO4
(3R,5R)-6-氰基-3,5-二羟基己酸叔丁酯
(3R,4S,5S,6R,7R,9R,11R,12S,13R,14R)-6-{[(2S,3R,4S,6R)-4-(二甲基氨基)-3-羟基-6-甲基四氢-2H-吡喃-2-基]氧基}-14-乙基-12-羟基-4-{[(2R,4R,5S,6S)-5-羟基-4-甲氧基-4,6-二甲基四氢-2H-吡喃-2-基]氧基}-7-甲氧基-3,5,7,9,11,13-六甲基氧杂环十四烷-2,10-二酮 6-O-methylerythromycin B 86976-45-6 C38H69NO12
(3R,4S,5S,6R,7R,9R,11R,12S,13R,14R)-6-{[(2S,3R,4S,6R)-4-(二甲基氨基)-3-羟基-6-甲基四氢-2H-吡喃-2-基]氧基}-14-乙基-12-羟基-4-{[(2R,4R,5S,6S)-5-羟基-4-甲氧基-4,6-二甲基四氢-2H-吡喃-2-基]氧基}-7-甲氧基-3,5,7,9,11,13-六甲基氧杂环十四烷-2,10-二酮
(3R,4R,5R)-3-(1-乙基丙氧基)-4-羟基-5-[(甲基磺酰基)氧基]-1-环己烯-1-羧酸乙酯 ethyl (3R,4R,5R)-3-(1-ethyl-propoxy)-4-hydroxy-5-methanesulfonyloxycyclohex-1-ene-1-carboxylate 204254-92-2 C15H26O7S
(3R,4R,5R)-3-(1-乙基丙氧基)-4-羟基-5-[(甲基磺酰基)氧基]-1-环己烯-1-羧酸乙酯
(3R)-N-叔丁氧羰基-3-氨基-4-(2,4,5-三氟苯基)丁酸甲酯 methyl (R)-3-((tert-butoxycarbonyl)amino)-4-(2,4,5-trifluorophenyl)butanoate 881995-73-9 C16H20F3NO4
(3R)-N-叔丁氧羰基-3-氨基-4-(2,4,5-三氟苯基)丁酸甲酯
(3R)-3-[[(2R)-环戊基羟基苯基乙酰基]氧基]-1,1-二甲基吡咯烷溴化物 R,R-glycopyrrolate 475468-09-8 Br*C19H28NO3
(3R)-3-[[(2R)-环戊基羟基苯基乙酰基]氧基]-1,1-二甲基吡咯烷溴化物
(3-氯-3-苯基丙基)-二甲胺盐酸盐 3-chloro-N,N-dimethyl-3-phenylpropan-1-amine 79130-51-1 C11H16ClN
(3-氯-3-苯基丙基)-二甲胺盐酸盐
(2s,4s)-4-[4-(3-甲基-1-苯基-1H-吡唑-5-基)-1-哌嗪]-2-(3-噻唑啉基羰基)-1-吡咯烷羧酸, 1,1-二甲基乙酯 tert-butyl (2S)-4-[4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl]-2-(1,3-thiazolidin-3-ylcarbonyl)pyrrolidine-1-carboxylate 401566-80-1 C27H38N6O3S
(2s,4s)-4-[4-(3-甲基-1-苯基-1H-吡唑-5-基)-1-哌嗪]-2-(3-噻唑啉基羰基)-1-吡咯烷羧酸, 1,1-二甲基乙酯
(2b,3a,16b,17b)-2,16-双(哌啶基)-3,17-二乙酰氧基-5-雄甾烷 (2β,3α,5α,16β,17β)-2,16-bispiperidino-3,17-diacetoxy-androstane 13529-31-2 C33H54N2O4
(2b,3a,16b,17b)-2,16-双(哌啶基)-3,17-二乙酰氧基-5-雄甾烷
(2Z)-氯[(4-甲氧基苯基)亚肼基]乙酸乙酯 (Z)-ethyl 2-chloro-2-(2-(4-methoxyphenyl)hydrazono)acetate 473927-63-8 C11H13ClN2O3
(2Z)-氯[(4-甲氧基苯基)亚肼基]乙酸乙酯
(2Z)-4-氧代-4-[3-(三氟甲基)-5,6-二氢-[1,2,4]三唑并[4,3-a]吡嗪-7(8H)-基]-1-(2,4,5-三氟苯基)丁-2-烯-2-胺 (Z)-3-amino-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)but-2-en-1-one 767340-03-4 C16H13F6N5O
(2Z)-4-氧代-4-[3-(三氟甲基)-5,6-二氢-[1,2,4]三唑并[4,3-a]吡嗪-7(8H)-基]-1-(2,4,5-三氟苯基)丁-2-烯-2-胺
(2Z)-2-氰基-3-(3,4-二羟基-5-硝基苯基)-N,N-二乙基-2-丙烯酰胺 (2Z)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide 145195-63-7 C14H15N3O5
(2Z)-2-氰基-3-(3,4-二羟基-5-硝基苯基)-N,N-二乙基-2-丙烯酰胺
(2Z)-2-[氰基(2,3-二氯苯基)亚甲基]脒基肼 2-(2,3-dichlorophenyl)-2-(aminoguanidine)-acetonitrile 94213-23-7 C9H7Cl2N5
(2Z)-2-[氰基(2,3-二氯苯基)亚甲基]脒基肼
(2S,5R)-3,3-二甲基-7-氧代-4-硫杂-1-氮杂双环[3.2.0]庚烷-2-羧酸二苯甲酯 4-氧化物 benzhydryl 6,6-dihydropenicillanate-1-oxide 87579-78-0 C21H21NO4S
(2S,5R)-3,3-二甲基-7-氧代-4-硫杂-1-氮杂双环[3.2.0]庚烷-2-羧酸二苯甲酯 4-氧化物
(2S,4S)-4-羟基-2-(噻唑烷-3-羰基)吡咯烷-1-甲酸叔丁酯 3-((2S,4S)-1-tert-butoxycarbonyl-4-hydroxy-2-pyrrolidinylcarbonyl)-1,3-thiazolidine 401564-34-9 C13H22N2O4S
(2S,4S)-4-羟基-2-(噻唑烷-3-羰基)吡咯烷-1-甲酸叔丁酯
(2S,4R)-4-(4-(3-甲基-1-苯基-1H-吡唑-5-基)哌嗪-1-基)-2-(噻唑烷-3 3-{(2S,4R)-1-(tert-butoxycarbonyl)-4-[4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl]-2-pyrrolidinylcarbonyl}-1,3-thiazolidine 1404559-22-3 C27H38N6O3S
(2S,4R)-4-(4-(3-甲基-1-苯基-1H-吡唑-5-基)哌嗪-1-基)-2-(噻唑烷-3
(2S,3r)-2-((s)-1-(3,5-双(三氟甲基)苯基)乙氧基)-3-(4-氟苯基)吗啉 (2S,3R)-2-[(1S)-1-(3,5-bis-trifluoro-methylphenyl)ethoxy]-3-(4-fluorophenyl)morpholine 327623-37-0 C20H18F7NO2
(2S,3r)-2-((s)-1-(3,5-双(三氟甲基)苯基)乙氧基)-3-(4-氟苯基)吗啉
(2S,3aS,7aS)-八氢吲哚-2-羧酸 (2S,3aS,7aS)-perhydroindole-2-carboxylic acid 80875-98-5 C9H15NO2
(2S,3aS,7aS)-八氢吲哚-2-羧酸
(2S,3S,5S)-5-[(N-甲酰基亮氨酰)氧基]-2-己基-3-羟基十六烷酸 (2S,3S,5S)-5-<<(S)-2-(Formylamino)-4-methylpentanoyl>oxy>-2-hexyl-3-hydroxyhexadecanoic Acid 130676-66-3 C29H55NO6
(2S,3S,5S)-5-[(N-甲酰基亮氨酰)氧基]-2-己基-3-羟基十六烷酸
(2S,3S)-2-[[(2Z)-2-(2-氨基-4-噻唑基)-2-[(1-羧基-1-甲基乙氧基)亚氨基]乙酰基]氨基]-3-(磺基氨基)丁酸 (2S,3S)-2-{[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-{[(2-carboxypropan-2-yl)oxy]imino}acetyl]amino}-3-(sulfoamino)butanoic acid 87500-74-1 C13H19N5O9S2
(2S,3S)-2-[[(2Z)-2-(2-氨基-4-噻唑基)-2-[(1-羧基-1-甲基乙氧基)亚氨基]乙酰基]氨基]-3-(磺基氨基)丁酸
(2S,3S)-2-(2,4-二氟苯基)-3-甲基-2-(1H-1,2,4-三唑-1-基)甲基环氧乙烷 (2S,3S)-2-(2,4-difluorophenyl)-3-methyl-2-(1H-1,2,4-triazol-1-yl)methyloxirane 135270-10-9 C12H11F2N3O
(2S,3S)-2-(2,4-二氟苯基)-3-甲基-2-(1H-1,2,4-三唑-1-基)甲基环氧乙烷
(2S,3R,4S,5S,6R)-2-[7-羟基-2-(4-羟基-3-甲氧基苯基)-5-[(2S,3R,4S,5S,6R)-3,4,5-三羟基-6-(羟基甲基)四氢吡喃-2-基]氧基苯并吡喃基鎓-3-基]氧基-6-(羟基甲基)四氢吡喃-3,4,5-三醇氯化物 Peonin chloride 132-37-6 C28H33O16*Cl
(2S,3R,4S,5S,6R)-2-[7-羟基-2-(4-羟基-3-甲氧基苯基)-5-[(2S,3R,4S,5S,6R)-3,4,5-三羟基-6-(羟基甲基)四氢吡喃-2-基]氧基苯并吡喃基鎓-3-基]氧基-6-(羟基甲基)四氢吡喃-3,4,5-三醇氯化物
(2S,3R,4S,5S,6R)-2-(4-氯-3-(4-乙氧基苄基)苯基)-6-(羟甲基)-2-甲氧基四氢-2H-吡喃-3,4,5-三醇 (2S,3R,4S,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)-2-methoxytetrahydro-2H-pyran-3,4,5-triol 714269-57-5 C22H27ClO7
(2S,3R,4S,5S,6R)-2-(4-氯-3-(4-乙氧基苄基)苯基)-6-(羟甲基)-2-甲氧基四氢-2H-吡喃-3,4,5-三醇
(2S,3R,4S,5S,6R)-2-(3-((5-(4-氟苯基)-2-噻吩)甲基)-4-甲苯基)-6-(羟甲基)-2-甲氧基-2H-3,4,5-三羟基四氢吡喃 (2S,3R,4S,5S,6R)-2-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methyl-phenyl]-6-(hydroxymethyl)-2-methoxy-tetrahydropyran-3,4,5-triol 1358581-37-9 C25H27FO6S
(2S,3R,4S,5S,6R)-2-(3-((5-(4-氟苯基)-2-噻吩)甲基)-4-甲苯基)-6-(羟甲基)-2-甲氧基-2H-3,4,5-三羟基四氢吡喃
(2S,3R,4S,5S)-2-(4-氯-3-(4-乙氧苄基)苯基)-6,6-双(羟甲基)-2-甲氧基四氢-2H-吡喃-3,4,5-三醇 (2S,3R,4S,5S)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6,6-bis(hydroxymethyl)-2-methoxytetrahydro-2H-pyran-3,4,5-triol 1528636-39-6 C23H29ClO8
(2S,3R,4S,5S)-2-(4-氯-3-(4-乙氧苄基)苯基)-6,6-双(羟甲基)-2-甲氧基四氢-2H-吡喃-3,4,5-三醇
(2S,3R,4R,5S,6R)-2-(4-氯-3-(4-甲氧基苄基)苯基)-6-(羟甲基)四氢-2 (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-methoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol 333359-90-3 C20H23ClO6
(2S,3R,4R,5S,6R)-2-(4-氯-3-(4-甲氧基苄基)苯基)-6-(羟甲基)四氢-2
(2S,3R)-2-(2,4-二氟苯基)-1-(1H-1,2,4-三唑-1-基)-2,3-丁二醇 (2S,3R)-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)-2,3-butanediol 135272-36-5 C12H13F2N3O2
(2S,3R)-2-(2,4-二氟苯基)-1-(1H-1,2,4-三唑-1-基)-2,3-丁二醇