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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
(E)-奥洛他定盐酸盐 (E )-11-[ 3-(dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid hydrochloride 949141-22-4 C21H23NO3*ClH
(E)-奥洛他定盐酸盐
(E)-奥洛他定 (E)-11-<3-(dimethylamino)propylidene>-6,11-dihydrodibenz<b,e>oxepin-2-acetic acid 113806-06-7 C21H23NO3
(E)-奥洛他定
(E)-7-[2-环丙基-4-(4-氟苯基)-3-喹啉基]-5-羟基-3-氧代-6-庚烯酸乙酯 (E)-7-[2-cyclopropyl-4-(4-fluorophenyl)-quinolin-3-yl]-5-hydroxy-3-oxohept-6-enic acid ethyl ester 148901-69-3 C27H26FNO4
(E)-7-[2-环丙基-4-(4-氟苯基)-3-喹啉基]-5-羟基-3-氧代-6-庚烯酸乙酯
(E)-4-氨基-2-丁烯酸 trans-4-aminocrotonic acid 38090-53-8 C4H7NO2
(E)-4-氨基-2-丁烯酸
(E)-4-乙酰氧基他莫昔芬 (E)-4-{1-[4-(2-dimethylaminoethoxy)phenyl]-2-phenylbut-1-enyl}phenyl acetate 76117-70-9 C28H31NO3
(E)-4-乙酰氧基他莫昔芬
(E)-4-[2-[3-叔丁氧基-3-氧代-1-丙烯基]苯基]-2,6-二甲基-3,5-吡啶二甲酸二乙酯 diethyl (E)-4-<2-<3-(1,1-dimethylethoxy)-3-oxoprop-1-enyl>phenyl>-2,6-dimethylpyridine-3,5-dicarboxylate 130996-24-6 C26H31NO6
(E)-4-[2-[3-叔丁氧基-3-氧代-1-丙烯基]苯基]-2,6-二甲基-3,5-吡啶二甲酸二乙酯
(E)-3-[氰基(2,3-二氯苯基)亚甲基]碳杂氮杂脒 (E)-2-(2,3-dichlorophenyl)-2-guanidinyliminoacetonitrile 94213-24-8 C9H7Cl2N5
(E)-3-[氰基(2,3-二氯苯基)亚甲基]碳杂氮杂脒
(E)-3-(4-羟基苯基)丙烯酸 (2S)-3-(beta-D-吡喃葡萄糖基氧基)-2-羟基丙基酯 Regaloside A 114420-66-5 C18H24O10
(E)-3-(4-羟基苯基)丙烯酸 (2S)-3-(beta-D-吡喃葡萄糖基氧基)-2-羟基丙基酯
(E)-2-甲氧基-4-(1-丙烯基苯酚) (E)-2-methoxy-4-(1-propenyl)phenol 5932-68-3 C10H12O2
(E)-2-甲氧基-4-(1-丙烯基苯酚)
(E)-2-氰基-5-甲基-2-己烯酸甲酯 2-cyano-5-methylhex-2-enoic acid methyl ester 96914-67-9 C9H13NO2
(E)-2-氰基-5-甲基-2-己烯酸甲酯
(E)-2-[3-[3-[2-(7-氯-2-喹啉基)乙烯基]苯基]-3-氧代丙基]苯甲酸甲酯 methyl 2-(3-(3-(2-(7-chloro-2-quinolinyl)ethenyl)phenyl)-3-oxopropyl)benzoate 149968-11-6 C28H22ClNO3
(E)-2-[3-[3-[2-(7-氯-2-喹啉基)乙烯基]苯基]-3-氧代丙基]苯甲酸甲酯
(E)-2-(((2-(2-氨基噻唑-4-基)-3-氧代-3-((2-氧代乙基)氨基)丙-1-烯-1-基)氨基)氧基)-2-甲基丙酸 2-((((1Z)-1-(2-Aminothiazol-4-yl)-2-((oxoethyl)amino)-2-oxoethylidene)amino)oxy)-2-methylpropanoic acid 194241-83-3 C11H14N4O5S
(E)-2-(((2-(2-氨基噻唑-4-基)-3-氧代-3-((2-氧代乙基)氨基)丙-1-烯-1-基)氨基)氧基)-2-甲基丙酸
(9ci)-4-硝基-1H-咪唑-2-羧醛 5-nitro-1H-imidazole-2-carbaldehyde 33543-81-6 C4H3N3O3
(9ci)-4-硝基-1H-咪唑-2-羧醛
(9ci)-1-甲基-4-硝基-1H-咪唑-5-胺 5-amino-1-methyl-4-nitroimidazole 4531-54-8 C4H6N4O2
(9ci)-1-甲基-4-硝基-1H-咪唑-5-胺
(9alpha,13alpha,14alpha)-3-甲氧基-吗喃-17-甲醛 17-formyl-3-methoxymorphinan 28973-48-0 C18H23NO2
(9alpha,13alpha,14alpha)-3-甲氧基-吗喃-17-甲醛
(9S)-9-氨基-9-脱氧乙琥红霉素 erythromycylamine 26116-56-3 C37H70N2O12
(9S)-9-氨基-9-脱氧乙琥红霉素
(8S,9S,10R,11S,13S,14S,16R,17S)-11,16,17-三羟基-17-(2-羟基乙酰基)-10,13-二甲基-2,6,7,8,9,11,12,14,15,16-十氢-1H-环戊并[a]菲-3-酮 11β,16α,17α,21-Tetrahydroxy-pregn-4-en-3,20-dion 1171-81-9 C21H30O6
(8S,9S,10R,11S,13S,14S,16R,17S)-11,16,17-三羟基-17-(2-羟基乙酰基)-10,13-二甲基-2,6,7,8,9,11,12,14,15,16-十氢-1H-环戊并[a]菲-3-酮
(8S,9R,10S,11S,13S,14S,16S)-9-氟-11-羟基-10,13,16-三甲基-6,7,8,11,12,14,15,16-八氢环戊烯并[a]菲-3,17-二酮 9α-fluoro-11β-hydroxy-16β-methylandrosta-1,4-diene-3,17-dione 3109-01-1 C20H25FO3
(8S,9R,10S,11S,13S,14S,16S)-9-氟-11-羟基-10,13,16-三甲基-6,7,8,11,12,14,15,16-八氢环戊烯并[a]菲-3,17-二酮
(8S,10S)-10-[(3-氨基-2,3,6-三脱氧-alpha-L-吡喃来苏己糖基)氧基]-8-(2-溴-1,1-二甲氧基乙基)-7,8,9,10-四氢-6,8,11-三羟基-1-甲氧基-5,12-并四苯醌 14-bromo-13-dimethylketal-daunorubicin 106401-68-7 C29H34BrNO11
(8S,10S)-10-[(3-氨基-2,3,6-三脱氧-alpha-L-吡喃来苏己糖基)氧基]-8-(2-溴-1,1-二甲氧基乙基)-7,8,9,10-四氢-6,8,11-三羟基-1-甲氧基-5,12-并四苯醌
(8S)-2-溴-alpha-麦角隐亭 (6aR,9S)-5-bromo-N-[(1S,2S,4R,7S)-2-hydroxy-7-(2-methylpropyl)-5,8-dioxo-4-propan-2-yl-3-oxa-6,9-diazatricyclo[7.3.0.02,6]dodecan-4-yl]-7-methyl-6,6a,8,9-tetrahydro-4H-indolo[4,3-fg]quinoline-9-carboxamide 65700-36-9 C32H40BrN5O5
(8S)-2-溴-alpha-麦角隐亭
(6alpha)-17-羟基-6-甲基-3,11,20-三氧代孕甾烷-1,4-二烯-21-基乙酸酯 6α-methylprednisone acetate 115321-98-7 C24H30O6
(6alpha)-17-羟基-6-甲基-3,11,20-三氧代孕甾烷-1,4-二烯-21-基乙酸酯
(6S)-羟基(S,S)-帕洛诺司琼 (6S)-Hydroxy (S,S)-Palonosetron 848074-08-8 C19H24N2O2
(6S)-羟基(S,S)-帕洛诺司琼
(6S)-3-己基-6-十一烷基-5,6-二氢-2H-吡喃-2-酮 (S)-3-Hexyl-5,6-dihydro-6-undecyl-2H-pyran-2-one 130676-64-1 C22H40O2
(6S)-3-己基-6-十一烷基-5,6-二氢-2H-吡喃-2-酮
(6R-顺式)-3-(羟基甲基)-7-甲氧基-8-氧代-7-(2-噻吩基乙酰氨基)-5-硫杂-1-氮杂双环[4.2.0]辛-2-烯-2-羧酸 (6R,7S)-3-(hydroxymethyl)-7-methoxy-8-oxo-7-[2-(2-thienyl)ethanoylamino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid 54333-94-7 C15H16N2O6S2
(6R-顺式)-3-(羟基甲基)-7-甲氧基-8-氧代-7-(2-噻吩基乙酰氨基)-5-硫杂-1-氮杂双环[4.2.0]辛-2-烯-2-羧酸
(6R,7R)-7-氨基-3-[(E)-1-丙烯-1-基]-3-头孢烯-4-羧酸 trans-7-amino-3-propen-1-yl-3-cephem-4-carboxylic acid 107937-01-9 C10H12N2O3S
(6R,7R)-7-氨基-3-[(E)-1-丙烯-1-基]-3-头孢烯-4-羧酸
(6R,7R)-7-[[2-氨基-2-(1-环己烯基)乙酰基]氨基]-3-甲基-8-氧代-5-硫杂-1-氮杂双环[4.2.0]辛-2-烯-2-羧酸 4',5'-Dihydrocefradine 37051-00-6 C16H21N3O4S
(6R,7R)-7-[[2-氨基-2-(1-环己烯基)乙酰基]氨基]-3-甲基-8-氧代-5-硫杂-1-氮杂双环[4.2.0]辛-2-烯-2-羧酸
(6E,10E)-7,11,15-三甲基-3-亚甲基-1,6,10,14-十六碳四烯e β-springene 70901-63-2 C20H32
(6E,10E)-7,11,15-三甲基-3-亚甲基-1,6,10,14-十六碳四烯e
(5S,6S,9R)-5-氨基-6-(2,3-二氟苯基)-6,7,8,9-四氢-5H-环庚[b]吡啶-9-醇 (5S,6S,9R)-5-Amino-6-(2,3-difluorophenyl)-6,7,8,9-tetrahydro-5H-cyclohepta[b]pyridin-9-ol 1373116-05-2 C16H16F2N2O
(5S,6S,9R)-5-氨基-6-(2,3-二氟苯基)-6,7,8,9-四氢-5H-环庚[b]吡啶-9-醇
(5E)-5-[(2-氨基乙氧基)亚氨基]-5-[4-(三氟甲基)苯基]-1-戊醇 Demethyl Fluvoxamine 192876-02-1 C14H19F3N2O2
(5E)-5-[(2-氨基乙氧基)亚氨基]-5-[4-(三氟甲基)苯基]-1-戊醇
(5-碘-2-氯苯基)(4-乙氧基苯基)甲酮 (2-chloro-5-iodophenyl)(4-ethoxyphenyl)methanone 1103738-26-6 C15H12ClIO2
(5-碘-2-氯苯基)(4-乙氧基苯基)甲酮
(5-氨基-2-丁基-3-苯并呋喃基)[4-[3-(二丁基氨基)丙氧基]苯基]甲酮 (5-amino-2-butylbenzofuran-3-yl)(4-(3-(dibutylamino)propoxy)phenyl)methanone 141644-91-9 C30H42N2O3
(5-氨基-2-丁基-3-苯并呋喃基)[4-[3-(二丁基氨基)丙氧基]苯基]甲酮
(4aS,6bR,8aR,10S,12aR,12bR,14bR)-10-[(6-脱氧-β-D-吡喃葡萄糖基)氧代]-2,2,6b,9,9,12a-六甲基-1,3,4,5,6,6b,7,8,8a,9,10,11,12,12a,12b,13,14,14b-十八氢苉-4a(2H)-羧酸 (4aS,6aR,6bR,8aR,10S,12aR,14bR)-2,2,6b,9,9,12a-hexamethyl-10-[(2R,3R,4S,5S,6R)-3,4,5-trihydroxy-6-methyloxan-2-yl]oxy-3,4,5,6,6a,7,8,8a,10,11,12,13,14,14b-tetradecahydro-1H-picene-4a-carboxylic acid 133453-54-0 C35H56O7
(4aS,6bR,8aR,10S,12aR,12bR,14bR)-10-[(6-脱氧-β-D-吡喃葡萄糖基)氧代]-2,2,6b,9,9,12a-六甲基-1,3,4,5,6,6b,7,8,8a,9,10,11,12,12a,12b,13,14,14b-十八氢苉-4a(2H)-羧酸
(4S,TRANS)-6-氨乙基-2,2-二甲基-1,3-二氧六环-4-乙酸叔丁酯 tert-butyl [(4S,6R)-6-(2-aminoethyl)-2,2-dimethyl-1,3-dioxane-4-yl]acetate 1105067-89-7 C14H27NO4
(4S,TRANS)-6-氨乙基-2,2-二甲基-1,3-二氧六环-4-乙酸叔丁酯
(4S,6R)-6-(氰基甲基)-2,2-二甲基-1,3-二恶烷-4-乙酸叔-丁酯 tert-butyl (4S,6R)-6-(cyanomethyl)-2,2-dimethyl-1,3-dioxane-4-acetate 186508-95-2 C14H23NO4
(4S,6R)-6-(氰基甲基)-2,2-二甲基-1,3-二恶烷-4-乙酸叔-丁酯
(4S)-2-[[[(2R)-2-氨基-2-(4-羟基苯基)乙酰基]氨基]甲基]-5,5-二甲基-4-噻唑烷羧酸 (S)-2-{[(R)-2-Amino-2-(4-hydroxy-phenyl)-acetylamino]-methyl}-5,5-dimethyl-thiazolidine-4-carboxylic acid 1356020-01-3 C15H21N3O4S
(4S)-2-[[[(2R)-2-氨基-2-(4-羟基苯基)乙酰基]氨基]甲基]-5,5-二甲基-4-噻唑烷羧酸
(4R-CIS)-6-氯甲基-2,2-二甲基-1,3-二氧戊环-4-乙酸叔丁酯 (4R-cis)-6-chloromethyl-2,2-dimethyl-1,3-dioxane-4-acetic acid tert-butyl ester 154026-94-5 C13H23ClO4
(4R-CIS)-6-氯甲基-2,2-二甲基-1,3-二氧戊环-4-乙酸叔丁酯
(4R,6S)-氰甲基-2,2-二甲基-1,3-二氧六环-4-乙酸叔丁酯 tert-Butyl 2-((4R,6S)-6-(cyanomethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetate 196085-84-4 C14H23NO4
(4R,6S)-氰甲基-2,2-二甲基-1,3-二氧六环-4-乙酸叔丁酯
(4R,6S)-6-[[(1E)-2-环丙基-4-(4-氟苯基)-3-喹啉基]乙烯基]-2,2-二甲基-1,3-二氧六环-4-乙酸叔丁酯 t-butyl (3R,5S,6E)-7-<2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl>-3,5-isopropylidenedioxy-6-heptenoate 147489-06-3 C32H36FNO4
(4R,6S)-6-[[(1E)-2-环丙基-4-(4-氟苯基)-3-喹啉基]乙烯基]-2,2-二甲基-1,3-二氧六环-4-乙酸叔丁酯
(4R,12aS)-3,4,6,8,12,12a-六氢-7-羟基-4-甲基-6,8-二氧代-2H-吡啶并[1',2':4,5]吡嗪并[2,1-b][1,3]恶嗪-9-羧酸 (4R)-7-hydroxy-4-methyl-6,8-dioxo-3,4,6,8,12,12ahexahydro-2H-pyrido[1′,2′:4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxylic acid 1246616-73-8 C13H14N2O6
(4R,12aS)-3,4,6,8,12,12a-六氢-7-羟基-4-甲基-6,8-二氧代-2H-吡啶并[1',2':4,5]吡嗪并[2,1-b][1,3]恶嗪-9-羧酸
(4R)-5-[1,1'-联苯]-4-基-4-[[叔丁氧羰基]氨基]-2-甲基-2-戊烯酸乙酯 (R)-5-biphenyl-4-yl-4-tert-butoxycarbonylamino-2-methylpent-2-enoic acid ethyl ester 149709-59-1 C25H31NO4
(4R)-5-[1,1'-联苯]-4-基-4-[[叔丁氧羰基]氨基]-2-甲基-2-戊烯酸乙酯
(4R)-4-[[3-[2-(二甲基氨基)乙基]-1H-吲哚-5-基]甲基]-2-恶唑烷酮 4-(R)-((3-(2-(dimethylamino)ethyl)-1H-indol-5-yl)methyl)oxazolidin-2-one 139264-24-7 C16H21N3O2
(4R)-4-[[3-[2-(二甲基氨基)乙基]-1H-吲哚-5-基]甲基]-2-恶唑烷酮
(4-羧基-2-乙氧基-苯基)-乙酸 4-(carboxymethyl)-2-ethoxybenzoic acid 220438-80-2 C11H12O5
(4-羧基-2-乙氧基-苯基)-乙酸
(4-羟基-3,5-二碘-苯基)-乙酸酰胺 (4-hydroxy-3,5-diiodo-phenyl)-acetic acid amide 100130-56-1 C8H7I2NO2
(4-羟基-3,5-二碘-苯基)-乙酸酰胺
(4-甲氧基苯基)(二苯基)甲氧基甲烷 (4-methoxyphenyl)(diphenyl)methoxymethane 84868-56-4 C21H20O2
(4-甲氧基苯基)(二苯基)甲氧基甲烷
(4-溴-3-氟苯基)氨基甲酸苄酯 benzyl (4-bromo-3-fluorophenyl)carbamate 510729-01-8 C14H11BrFNO2
(4-溴-3-氟苯基)氨基甲酸苄酯
(4-氯苯基)甲醇 <(1-ethyl-3-piperidyl)methyl>amine 102459-02-9 C8H18N2
(4-氯苯基)甲醇
(4-{1-羟基-2-[6-(4-苯基-丁-2-基氧基)己基氨基]乙基}-2-(羟甲基)苯酚) 4-(1-Hydroxy-2-((6-((4-phenylbutan-2-yl)oxy)hexyl)amino)ethyl)-2-(hydroxymethyl)phenol 108928-81-0 C25H37NO4
(4-{1-羟基-2-[6-(4-苯基-丁-2-基氧基)己基氨基]乙基}-2-(羟甲基)苯酚)
(4-(2-(氮杂环庚烷-1-基)乙氧基)苯基)甲醇 1-[2-(4-hydroxymethyl-phenoxy)-ethyl]azepane 223251-16-9 C15H23NO2
(4-(2-(氮杂环庚烷-1-基)乙氧基)苯基)甲醇
(3’R)-依折麦布 (3R,4S)-1-(4-fluorophenyl)-3-[(3R)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)-azetidin-2-one 163380-16-3 C24H21F2NO3
(3’R)-依折麦布
(3beta, 5Z,7E)-9,10-开链胆甾-5,7,10(19)-三烯-3-基丁酸酯 vitamin D<sub>3</sub> butyrate 31316-20-8 C31H50O2
(3beta, 5Z,7E)-9,10-开链胆甾-5,7,10(19)-三烯-3-基丁酸酯