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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2-(乙酰氧基甲基)-4-甲氧基-3,5-二甲基吡啶 | (4-methoxy-3,5-dimethyl-pyridin-2-yl)methyl acetate | 91219-90-8 | C11H15NO3 |
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2-(乙酰基磺酰基)乙烷磺酸 | 2-(acetylthio)ethane-1-sulfonic acid | 69536-71-6 | C4H8O4S2 |
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2-(三氟甲基)苯丙醇 | 3-(2-(trifluoromethyl)phenyl)propan-1-ol | 191155-81-4 | C10H11F3O |
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2-(6-甲氧基-2-萘基)丙酸 | naproxen | 23981-80-8 | C14H14O3 |
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2-(5-溴苯并呋喃-3-基)乙酸乙酯 | (5-Bromobenzofuran-3-yl)acetic acid ethyl ester | 200204-85-9 | C12H11BrO3 |
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2-(5-溴喹喔啉-6-基)胍 | 5-bromo-6-guanidinoquinoxaline | 168329-48-4 | C9H8BrN5 |
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2-(4-羟基苯基)-4-甲基-5-噻唑羧酸 | 2-(4-hydroxyphenyl)-4-methylthiazole-5-carboxylic acid | 886501-78-6 | C11H9NO3S |
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2-(4-羟基-2-氧代吡咯烷-1-基)乙酸甲酯 | Methyl 2-(4-hydroxy-2-oxopyrrolidin-1-yl)acetate | 85614-52-4 | C7H11NO4 |
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2-(4-甲氧基苯基)肼基-2-氧代乙酸乙酯 | Oxalsaeureaethylester-N<sup>2</sup>-<p-methoxy-phenyl>-hydrazid | 2614-10-0 | C11H14N2O4 |
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2-(4-甲基-2-苯基-1-哌嗪基)-3-吡啶甲醇 | 2-(4-methyl-2-phenyl-1-piperazinyl)-3-pyridinemethanol | 61337-89-1 | C17H21N3O |
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2-(4-氯-3-甲基-2-吡啶基甲硫基)-1H-苯并咪唑 | 2-[(4-chloro-3-methylpyridin-2-yl)methylsulfanyl]-1H-benzoimidazole | 103312-62-5 | C14H12ClN3S |
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2-(4-氯-3-氨基磺酰基苯甲酰基)苯甲酸 | 2-(4-chloro-3-sulfamoyl-benzoyl)-benzoic acid | 5270-74-6 | C14H10ClNO5S |
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2-(4-氯-2-硝基苯基)氨基苯甲酸 | 2-(4-chloro-2-nitroanilino)benzoic acid | 60091-87-4 | C13H9ClN2O4 |
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2-(4-异丁基苯基)-1-丙醇 | 2-(4-isobutylphenyl)propan-1-ol | 36039-36-8 | C13H20O |
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2-(4-哌啶)-1H-苯并咪唑 | 2-(4-piperidinyl)-1H-benzimidazole | 38385-95-4 | C12H15N3 |
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2-(4-二苯甲基哌嗪)乙基 乙酰乙酸酯 | 2-(4-diphenylmethyl-1-piperazinyl)ethyl acetoacetate | 89226-49-3 | C23H28N2O3 |
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2-(4-二苯甲基-1-哌嗪基)乙基-3-氨基丁烯酸酯 | 2-(4-diphenylmethyl-1-piperazinyl)ethyl 3-aminocrotonate | 90096-33-6 | C23H29N3O2 |
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2-(4-((4-氯苯基)(苯基)甲基)哌嗪-1-基)乙酸 | 2-(4-((4-chlorophenyl)(phenyl)methyl)piperazin-1-yl)acetic acid | 113740-61-7 | C19H21ClN2O2 |
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2-(4,6-二氨基-1,3,5-三嗪-2-基)胍 | 2,4-diamino-6-guanidino-1,3,5-triazine | 4405-08-7 | C4H8N8 |
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2-(3-甲氧基苯氧基)乙胺 | 2-(3-methoxyphenoxy)ethanamine | 6487-86-1 | C9H13NO2 |
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2-(3-溴-4-氯吡啶-2-基)乙醇 | methyl 2-hydroxy-2-(thiophen-2-yl)-2-(thiophen-3-yl)acetate | 28748-67-6 | C11H10O3S2 |
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2-(3-氰基-4-异丁氧基苯基)-4-甲基噻唑-5-甲酸甲酯 | methyl 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate | 923942-34-1 | C17H18N2O3S |
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2-(3-氯苯基)-2-氰基-1-(3-吡啶基)-1-乙酮 | 2-(3-Chlorophenyl)-2-cyano-1-(3-pyridinyl)-1-ethanone | 114444-10-9 | C14H9ClN2O |
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2-(3-氯丙氧基)-1-甲氧基-4-硝基苯 | 1-(2-methoxy-5-nitrophenoxy)-3-chloropropane | 92878-95-0 | C10H12ClNO4 |
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2-(3-氯-2-羟基丙基)异吲哚-1,3-二酮 | 2-(3-chloro-2-hydroxypropyl)-1H-isoindole-1,3(2H)-dione | 19667-37-9 | C11H10ClNO3 |
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2-(3,4-二羟基苯基)乙醛 | 3,4-Dihydroxyphenylacetaldehyde | 5707-55-1 | C8H8O3 |
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2-(3,4-二羟基苯基)-2-羟基-乙醛 | 3,4-dihydroxyphenylglycolaldehyde | 13023-73-9 | C8H8O4 |
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2-(2-羧乙基氨基甲酰基)苯甲酸 | <i>N</i>-(2-carboxy-ethyl)-phthalamic acid | 103646-38-4 | C11H11NO5 |
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2-(2-硝基苯基)乙胺 | 2-(2-aminoethyl)nitrobenzene | 33100-15-1 | C8H10N2O2 |
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2-(2-甲烷氧基苯氧基)-N-甲基乙胺 | [2-(2-Methoxyphenoxy)ethyl]methylamine | 72955-82-9 | C10H15NO2 |
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2-(2-甲氧基苯氧基)乙醇 | 2-(2-methoxyphenoxy)ethanol | 18181-71-0 | C9H12O3 |
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2-(2-氰基苯基)苯甲腈 | biphenyl-2,2'-dicarbonitrile | 4341-02-0 | C14H8N2 |
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2-(2-氯乙胺基)乙醇 | β-Chlorethyl-β-hydroxyethyl-amin | 3890-98-0 | C4H10ClNO |
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2-(2-氯乙基)噻吩 | 2-(2-chloroethyl)thiophene | 19995-38-1 | C6H7ClS |
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2-(2-氧代-2,5-二氢-1H-吡咯-1-基)乙酰胺 | 2-(Δ<sup>3</sup>-Pyrrolin-2-on-1-yl)acetamid | 62833-66-3 | C6H8N2O2 |
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2-(2-乙氧基苯氧基)乙醇,甲磺酸 | 2-(2-ethoxyphenoxy)ethyl methanesulfonate | 169506-15-4 | C11H16O5S |
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2-(2-(4-(二苯并[b,f][1,4]硫氮杂卓-11-基)哌嗪-1-基)乙氧基)乙醇 | 2-(2-amino-phenylsulfanyl)-phenyl-{4-(2-(2-hydroxyethoxy)ethyl)piperazin-1-yl}methanone | 848814-27-7 | C21H27N3O3S |
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2-(2-(4-(二苯并[b,f][1,4]硫氮杂卓-11-基)哌嗪-1-基)乙氧基)乙基乙酸酯 | 11-[4-[2-(2-(2-acetyloxy)ethoxy)ethyl]-1-piperazinyl]dibenzo [b,f][1,4]thiazepine | 844639-07-2 | C23H27N3O3S |
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2-(2,4-二硝基苯基)乙胺 | 2,4-dinitro-phenethylamine | 91828-74-9 | C8H9N3O4 |
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2-(2,4-二氟苯基)-3-(1H-1,2,4-三氮唑-1-基)-1,2-丙二醇 | (S)-(+)-2(2,4-Difluorophenyl)-3-(1,2,4-triazol-1-yl)-1,2-propanediol | 118689-07-9 | C11H11F2N3O2 |
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2-(2,4-二氟苯基)-1-(1H-1,2,4-噻唑-1-基)-3-(4H-1,2,4-三唑-4-基)-2-丙醇 | Iso Fluconazole | 89429-59-4 | C13H12F2N6O |
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2-((4-甲基哌嗪-1-基)甲基)苯甲腈 | 2-((4-Methylpiperazin-1-yl)methyl)benzonitrile | 864069-00-1 | C13H17N3 |
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2-(((5-二甲基氨基)甲基)-2-呋喃基)甲基)硫代乙胺 | 5-{[(2-aminoethyl)thio]methyl}-N,N-dimethyl-2-furfurylamine | 66356-53-4 | C10H18N2OS |
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2,8-二氯-5,6-二氢-11H-苯并[5,6]环庚并[1,2-b]吡啶-11-酮 | 2,8-DICHLORO-5,6-DIHYDRO-11H-BENZO[5,6]CYCLOHEPTA[1,2-b]PYRIDIN-11-ONE | 133330-61-7 | C14H9Cl2NO |
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2,7-二氨基-6-苯基-4-蝶啶醇 | 2,7-diamino-6-phenyl-3<i>H</i>-pteridin-4-one | 19375-89-4 | C12H10N6O |
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2,6-二甲基-4-(4-硝基苯基)-1,4-二氢吡啶-3,5-二羧酸二甲酯 | 4-(4-nitrophenyl)-2,6-dimethyl-3,5-dimethoxycarbonyl-1,4-dihydropyridine | 21829-09-4 | C17H18N2O6 |
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2,6-二甲基-4-(3-硝基苯基)-吡啶-3,5-二羧酸二甲酯 | dimethyl 2,6-dimethyl-4-(m-aminophenyl)pyridine-3,5-dicarboxylate | 76258-20-3 | C17H16N2O6 |
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2,6-二甲基-4-(3-硝基苯基)-吡啶-3,5-二羧酸-3-乙酯-5-甲酯 | (+/-)-Oxidized Nitrendipine | 89267-41-4 | C18H18N2O6 |
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2,6-二甲基-4-(2-硝基苯基)-1,4-二氢吡啶-3,5-二羧酸 | 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylic acid | 74378-10-2 | C15H14N2O6 |
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2,6-二叔-丁基-4-亚甲基环己-2,5-二烯-1-酮 | 2,6-di-tert-butyl-4-methylene-2,5-cyclohexadien-1-one | 2607-52-5 | C15H22O |
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