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 |
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1-肼基-3-甲硫基-2-丙醇 | 3-methylthio-2-hydroxypropylhydrazine | 14359-97-8 | C4H12N2OS |
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1-羟基乙酰基-L-脯氨酰胺 | 1-glycoloyl-L-proline amide | 96166-39-1 | C7H12N2O3 |
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1-甲酰氨基-3,5-二甲基金刚烷 | 1-formamido-3,5-dimethyltricyclo[3.3.1.1<sup>3,7</sup>]decane | 351329-88-9 | C13H21NO |
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1-甲基靛红 | 1-methyl-1H-indole-2,3-dione | 2058-74-4 | C9H7NO2 |
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1-甲基-5-巯基四唑钠盐 | sodium 1-methyl-1H-1,2,3,4-tetrazole-5-thiol | 51138-06-8 | C2H4N4NaS+ |
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1-甲基-4-苯基-3-三氟甲基-1H-吡唑-5-胺 | 2-methyl-4-phenyl-5-trifluoromethyl-2<i>H</i>-pyrazol-3-ylamine | 63156-74-1 | C11H10F3N3 |
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1-甲基-4-硝基-3-丙基-1H-吡唑-5-羧酸 | 1-methyl-4-nitro-3-propyl-1H-pyrazole-5-carboxylic acid | 139756-00-6 | C8H11N3O4 |
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1-甲基-4-[甲基[(甲基氨基)羰基]氨基]-1H-咪唑-5-羧酸 | 5-(1,3-dimethyl-ureido)-3-methyl-3<i>H</i>-imidazole-4-carboxylic acid | 54536-15-1 | C8H12N4O3 |
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1-甲基-2-氧代环戊烷-1-羧酸乙酯 | ethyl 1-methyl-2-oxocyclopentane-1-carboxylate | 5453-88-3 | C9H14O3 |
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1-甲基-2-(甲硫基)咪唑 | 2-methylmercapto-3-methylimidazole | 14486-52-3 | C5H8N2S |
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1-甲基-1H-吲唑-3-羧酸酸酐 | 1-methyl-1H-indazole-3-carboxylic anhydride | 1363173-34-5 | C18H14N4O3 |
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1-甲基-12-噻吩基氧代吡啶并[1,2,3,4]咪唑-[1,2-a]苯并咪唑-2(12H)-酮 | 1-Methyl-12-thioxopyrido[1,2,3,4]imidazole-[1,2-a]benzimidazole-2(12H)-one | 1246819-06-6 | C14H9N3OS |
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1-环己基-3-[对[(环己基氨基甲酰基)氨基磺酰基]苯乙基]脲 | 1-cyclohexyl-3-[[4-[2-[(cyclohexylaminoformyl)amino]ethyl]phenyl]sulfonyl]urea | 10079-35-3 | C22H34N4O4S |
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1-环丙基-6-氟-7-(1-哌嗪基)-4(1H)-喹啉酮 | 1-cyclopropyl-6-fluoro-7-(piperazin-1-yl)quinolin-4(1H)-one | 105394-83-0 | C16H18FN3O |
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1-环丙基-6,7-二氟-1,4-二氢-8-羟基-4-氧代-3-喹啉羧酸乙酯 | ethyl 1-cyclopropyl-6,7-difluoro-1,4-dihydro-8-hydroxy-4-oxoquinoline-3-carboxylate | 452092-31-8 | C15H13F2NO4 |
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1-环丙基-6,7-二氟-1,4-二氢-8-乙氧基-4-氧代-3-喹啉羧酸 | 1-cyclopropyl-8-ethoxy-6,7-difluoro-1,4-dihydro-4-oxo-3-quinoline-carboxylic acid | 143158-55-8 | C15H13F2NO4 |
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1-环丙基-6,7,8-三氟-1,4-二氢-4-氧代-3-喹啉羧酸乙酯 | 1-cyclopropyl-6,7,8-trifluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid ethyl ester | 94242-51-0 | C15H12F3NO3 |
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1-烯丙基-3-(三氟甲基)苯 | 3-<3-(trifluoromethyl)phenyl>propene | 1813-96-3 | C10H9F3 |
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1-氰基环己烷乙酸 | 1-cyanocyclohexaneacetic acid | 133481-09-1 | C9H13NO2 |
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1-氰基-3-异丙基胍 | 3-cyano-1-isopropylguanidine | 44830-55-9 | C5H10N4 |
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1-氰基-2-辛基胍 | N-octyl-N'-cyanoguanidine | 60852-95-1 | C10H20N4 |
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1-氯-3-[4-(2-甲氧基乙基)苯氧基]-2-丙醇 | 1-chloro-3-[4-(2-methoxyethyl)phenoxy]-2-propanol | 56718-76-4 | C12H17ClO3 |
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1-氯-3-(氯苯基甲基)苯 | 3-chlorobenzhydryl chloride | 13391-39-4 | C13H10Cl2 |
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1-氯-2-亚硝基-苯 | o-Chloronitrosobenzene | 932-33-2 | C6H4ClNO |
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1-氯-2-(二甲氧基甲基)苯 | 2-chlorobenzaldehyde dimethyl acetal | 70380-66-4 | C9H11ClO2 |
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1-氮杂丁烷磺酰胺 | azetidine-1-sulfonamide | 654073-32-2 | C3H8N2O2S |
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1-氨基-3-硝基金刚烷 | 3-nitro-1-amantadine | 243145-00-8 | C10H16N2O2 |
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1-氧代米氮平 | 3,4,10,14b-tetrahydro-2-methyl-2H-pyrazino[2,1-a]pyrido[2,3-c][2]benzazepin-1-one | 191546-96-0 | C17H17N3O |
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1-氧代班布特罗 | 5-(2-(tert-butylamino)ethanoyl)-1,3-phenylene-bis(N,N-dimethylcarbamate) | 112935-94-1 | C18H27N3O5 |
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1-氧代-1-氮杂双环[2.2.2]辛-3-基1-苯基-3,4-二氢-2(1H)-异喹啉羧酸酯 | (1'S,3R)-3-[[(1'-phenyl-1',2',3',4'-tetrahydro-2'-isoquinolyl)carbonyl]oxy]quinuclidine 1-oxide | 180272-28-0 | C23H26N2O3 |
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1-氟-4-硝基苯 | 4-fluoro-nitrosobenzene | 352-15-8 | C6H4FNO |
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1-异丙基氨基-3-(对甲苯氧基)-2-丙醇 | F3254-0064 | 5790-46-5 | C13H21NO2 |
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1-吡啶-3-基乙酮肟 | 1-(pyridin-3-yl)ethanone oxime | 5973-83-1 | C7H8N2O |
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1-吡咯烷基(4,5,6,7-四氢-1H-苯并咪唑-6-基)甲酮盐酸盐 | N-[(4,5,6,7-tetrahydrobenzimidazol-5-yl)carbonyl]pyrrolidine hydrochloride | 132036-42-1 | C12H17N3O*ClH |
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1-去甲基尼麦角林 | 5-bromo-nicotinic acid 10-methoxy-6-methyl-ergolin-8-ylmethyl ester | 35264-46-1 | C23H24BrN3O3 |
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1-二苯甲基-4-(2-羟乙基)哌嗪二盐酸盐 | 4-(Diphenylmethyl)-1-piperazineethanol dihydrochloride | 108983-83-1 | C19H26Cl2N2O |
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1-二甲基氨基-2-苯基丁烷-2-基3,4,5-三甲氧基苯甲酸酯 | 1-(Dimethylamino)-2-phenyl-2-butanyl 3,4,5-trimethoxybenzoate | 92414-09-0 | C22H29NO5 |
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1-乙酰基-三-苄氧基-罗伯糖 | 1-O-acetyl-2,3,5-tri-O-benzoyl-D-ribofuranose | 14215-97-5 | C28H24O9 |
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1-乙酰基-N-(5-氯-2,1,3-苯并噻二唑-4-基)-4,5-二氢-1H-咪唑-2-胺 | 5-chloro-N-(N-acetyl-4,5-dihydro-1H-imidazol-2-yl)-2,1,3-benzothiadiazol-4-amine | 173532-15-5 | C11H10ClN5OS |
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1-乙酰基-2-甲基苯并咪唑 | 1-Acetyl-2-methyl-benzimidazol | 14678-81-0 | C10H10N2O |
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1-乙酰基-2-咪唑烷硫酮 | 1-Acetyl-imidazolidin-2-thion | 5391-52-6 | C5H8N2OS |
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1-乙基-3(3-二甲基氨基)脲 | 1-(3-(dimethylamino)propyl)-3-ethylurea | 32897-26-0 | C8H19N3O |
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1-{4-[2-(环丙基甲氧基)-乙基]-苯氧基}-2,3-环氧丙烷 | 1-[2-(cyclopropyl-methoxy)-ethyl]-4-(2,3-epoxypropoxy)-benzene | 63659-17-6 | C15H20O3 |
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1-[[[(1R)-1-[3-[(1S)-1-[[[1-(羧甲基)环丙基]甲基]硫基]-2-(7-氯-2-喹啉基)乙基]苯基]-3-[2-(1-羟基-1-甲基乙基)苯基]丙基]硫基]甲基]环丙烷乙酸 | [R, E]-[[1-[3-[2-(7-chloro-2-quinolinyl)-2-(R)-[(carboxymethyl)cyclopropyl]methyl]thio]ethyl]phenyl]-3-[[[[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]-cyclopropane acetic acid | 1187586-58-8 | C41H46ClNO5S2 |
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1-[[4-[(6,7-二甲氧基喹啉-4-基)氧基]苯基]氨基甲酰基]环丙烷羧酸卡博替尼杂质 | 1-[4-(6,7-dimethoxyquinolin-4-yloxy)phenylcarbamoyl]cyclopropane carboxylic acid | 849217-77-2 | C22H20N2O6 |
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1-[[2'-(2,5-二氢-5-氧代-1,2,4-恶二唑-3-基)联苯-4-基]甲基]-2-乙氧基-1H-苯并咪唑-7-羧酸乙酯 | ethyl 2-ethoxy-1-((2′-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl)methyl)-1H-benzo[d]-imidazole-7-carboxylate | 1403474-70-3 | C27H24N4O5 |
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1-[[(2R,3R)-2-(2,4-二氟苯基)-3-甲基-2-环氧乙烷基]甲基]-1H-1,2,4-三唑 | 1-(((2R,3R)-2-(2,4-difluorophenyl)-3-methyloxiran-2-yl)-methyl)-1H-1,2,4-triazole | 135270-13-2 | C12H11F2N3O |
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1-[5-[(3,4-二氢-4-氧代-1-酞嗪基)甲基]-2-氟苯甲酰基]哌嗪 | 4-(4-fluoro-3-(piperazine-1-carbonyl)benzyl)phthalazin-1(2H)-one | 763111-47-3 | C20H19FN4O2 |
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1-[4-溴-2-(羟基甲基)苯基]-4-(二甲基氨基)-1-(4-氟苯基)-1-丁醇盐酸盐(1:1) | 4-(4-(dimethylamino)-1-(4-fluorophenyl)-1-hydroxybutyl)-3-(hydroxymethyl)benzobromide | 488148-10-3 | C19H23BrFNO2 |
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1-[4-[2-(二甲基氨基)乙氧基]苯基]-2-苯基-1-丁酮 | 1-[4-[2-(N,N-dimethylamino)ethoxy]phenyl]-2-phenyl-1-butanone | 68047-07-4 | C20H25NO2 |
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