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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2,6-二丙-2-基环己-2,5-二烯-1,4-二酮 | 2,6-diisopropyl-1,4-benzoquinone | 1988-11-0 | C12H16O2 |
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2,5-脱水-1,3,4-三脱氧-2-C-(2,4-二氟苯基)-4-(羟甲基)-1-(1H-1,2,4-三唑-1-基)-D-苏式-戊糖醇 | ((3R,5R)-5-((1H-1,2,4-triazol-1-yl)methyl)-5-(2,4-difluorophenyl)tetrahydrofuran-3-yl)methanol | 160709-02-4 | C14H15F2N3O2 |
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2,5-二羟基-苯-1,3-二磺酸 | 2,5-dihydroxy-benzene-1,3-disulfonic acid | 81010-88-0 | C6H6O8S2 |
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2,5-二羟基-L-酪氨酸 | 2,4,5-trihydroxyphenyl-L-alanine | 27244-64-0 | C9H11NO5 |
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2,4-二溴-5-甲基苯酚 | 2,4-dibromo-5-methylphenol | 13321-76-1 | C7H6Br2O |
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2,4-二溴-3-甲基苯酚 | 2,4-dibromo-3-methylphenol | 13321-75-0 | C7H6Br2O |
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2,4-二氰基苯酚 | 2,4-dicyanophenol | 34133-58-9 | C8H4N2O |
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2,4-二氨基-6-苯基-7-蝶啶醇 | 2,4-diamino-6-phenyl-7(8H)-pteridinone | 19152-93-3 | C12H10N6O |
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2,4-二氨基-6-羟基甲基-7-羟基蝶啶 | 2,4-diamino-6-hydroxymethyl-8<i>H</i>-pteridin-7-one | 54643-27-5 | C7H8N6O2 |
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2,4-二氨基-6-二甲氨基-1,3,5-三嗪 | N,N-dimethylmelamine | 1985-46-2 | C5H10N6 |
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2,4-二氧代-3-氮杂螺[5.5]十一烷-1,5-二甲腈 | 2,4-dioxo-3-azaspiro[5.5]undecane-1,5-dicarbonitrile | 4355-15-1 | C12H13N3O2 |
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2,4-二氢-4-[4-[4-(4-甲氧基苯基)-1-哌嗪基]苯基]-2-(1-甲基丙基)-3H-1,2,4-三唑-3-酮 | 2-(sec-butyl)-4-(4-(4-(4-methoxyphenyl)piperazin-1-yl)phenyl)-2,4-dihydro-3H-1,2,4-triazol-3-one | 252964-68-4 | C23H29N5O2 |
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2,4-二(糠基氨基)-5-氨基磺酰基苯甲酸 | 4-<Furyl-(2)-methylamino>-5-sulfamoyl-N-<furyl-(2)-methyl>-anthranilsaeure | 5046-19-5 | C17H17N3O6S |
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2,4,6-三丙基-1,3,5-三氧杂环己烷 | 2,4,6-tripropyl-1,3,5-trioxane | 2396-43-2 | C12H24O3 |
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2,4,5-三氟-3-甲氧基苯甲酰氯 | 2,4,5-trifluoro-3-methoxybenzoyl chloride | 112811-66-2 | C8H4ClF3O2 |
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2,4'-二氨基二苯砜 | 2.4'-Sulfonylbis(benzolamin) | 27147-69-9 | C12H12N2O2S |
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2,4'-(2-吡啶亚甲基)二苯酚二乙酸酯 | 2,4'-(Pyridin-2-ylmethylene)diphenyl diacetate | 111664-35-8 | C22H19NO4 |
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2,3-脱氢水飞蓟宾B | 2,3-dehydrosilybin B | 142796-24-5 | C25H20O10 |
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2,3-环氧-16-(1-吡咯基)-雄甾-17-酮 | 2α,3α-epoxy-16β-(1-pyrrolidinyl)-5α-androstan-17-one | 159325-45-8 | C23H35NO2 |
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2,3-二甲基萘-1,4-二酮 | 2,3-dimethyl[1,4]naphthoquinone | 2197-57-1 | C12H10O2 |
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2,3-二甲基苯胺 | 2,3-Dimethylaniline | 87-59-2 | C8H11N |
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2,3-二氯吡啶-5-羰酰氯 | 5,6-dichloronicotinoyl chloride | 54127-29-6 | C6H2Cl3NO |
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2,3-二氢-3-氧代-1,2-苯并异噻唑-2-乙酸甲酯1,1-二氧化物 | methyl 3-oxo-2,3-dihydrobenzo[d][1,2]thiazol-2-acetate 1,1-dioxide | 6639-62-9 | C10H9NO5S |
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2,3,4-三甲氧基氯苄 | 2,3,4-trimethoxybenzyl chloride | 1133-49-9 | C10H13ClO3 |
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2,2-二苯基海因酸 | 2.2-Diphenylhydantoinsaeure | 6802-95-5 | C15H14N2O3 |
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2,2-二甲基-4-异丙基-1,3-苯并二恶茂 | 2,2-dimethyl-4-(1-methylethyl)-1,3-benzodioxole | 201166-22-5 | C12H16O2 |
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2,2-二溴-1-(2-氯苯基)乙酮 | 2,2-dibromo-1-(2-chlorophenyl)ethanone | 34356-83-7 | C8H5Br2ClO |
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2,2-二氯丙酰氯 | 2,2-dichloropropionyl chloride | 26073-26-7 | C3H3Cl3O |
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2,2-二氯-N-(2,6-二甲基苯基)乙酰胺 | 2,2-dichloro-N-(2,6-dimethylphenyl)acetamide | 39084-88-3 | C10H11Cl2NO |
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2,2,4-三氯-3-氧代丁酸乙酯 | ethyl 2,2,4-trichloro-3-oxobutyrate | 85153-67-9 | C6H7Cl3O3 |
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2,2'-亚氨基双(N-(2,6-二甲苯基)乙酰胺盐酸盐 | N-(2,6-dimethylphenyl)-2-({2-[(2,6-dimethylphenyl)amino]-2-oxoethyl}amino)acetamide hydrochloride | 1135231-62-7 | C20H26ClN3O2 |
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2,2'-[{4-[(3-乙炔基苯基)氨基]-6,7-喹唑啉二基}二(氧基)]二乙醇盐酸盐(1:1) | 2-[4-(3-Ethynyl-phenylamino)-7-(2-hydroxy-ethoxy)-quinazolin-6-yloxy]-ethanol hydrochloride | 183320-12-9 | C20H19N3O4*ClH |
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2,2'-[1,5-戊烷二基二[氧代(3-氧-3,1-丙烷二基)]]二[1-(3,4-二甲氧苯基) | Atracurium besylate, (1R,2S,1'S,2'R)- | 96946-54-2 | C65H82N2O18S2 |
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2'-(2H-四唑-5-基)-[1,1'-联苯]-4-甲醇 | 2'-(2H-tetrazol-5-yl)-[1,1'-biphenyl]-4-methanol | 160514-13-6 | C14H12N4O |
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2',6'-二(苄氧基)苯乙酮 | 1-[2',6'-bis(phenylmethoxy)phenyl]ethanone | 3886-19-9 | C22H20O3 |
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2',3'-O-异亚丙基胞苷 | 2',3'-Isopropyliden-cytidin | 362-42-5 | C12H17N3O5 |
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2',3',5'-三乙酰基-5-氮杂胞苷 | 2',3',5'-triacetyl-5-Azacytidine | 10302-78-0 | C14H18N4O8 |
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1beta-羟基维他命D3 | 1α-hydroxyvitamin D<sub>3</sub> | 63181-13-5 | C27H44O2 |
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1beta-羟基-6alpha-甲基-1,4-雄甾二烯-3,17-二酮 | 11β-hydroxy-6α-methyl-1,4-androstadiene-3,17-dione | 61919-52-6 | C20H26O3 |
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1H-苯并咪唑-2-亚磺酸 | benzimidazole-2-sulfinic acid | 58536-71-3 | C7H6N2O2S |
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1H-嘌呤-2,6-二酮,8-[2-(3,4-二羟基苯基)乙烯基]-1,3-二乙基-3,7-二氢-7-甲基-,(E)-(9CI) | (E)-8-(3,4-Dihydroxystyryl)-1,3-diethyl-7-methylxanthine | 155272-03-0 | C18H20N4O4 |
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1H-吡唑[3,4-C]吡啶-3-羧基酸,6-[4-[(5-溴-1-氧戊基)氨基]苯基]-4,5,6,7-四氢-1-(4-甲氧基)-7-氧代乙酯 | ethyl 1-(4-methoxyphenyl)-7-oxo-6-[4-(5-bromovaleroylamino)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate | 881386-12-5 | C27H29BrN4O5 |
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1H-吡唑-1-丙腈,Β-环戊基-4-[7-(羟基甲基)-7H-吡咯并[2,3-D]嘧啶-4-基]-,(ΒR)- | Ruxolitinib N-Methanol | 1236033-03-6 | C18H20N6O |
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1H-1-乙基坎地沙坦西来替昔酯 | (1RS)-1-[[(cyclohexyloxy)carbonyl]oxy]ethyl 2-ethoxy-1-[[2'-(1-ethyl-1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-benzimidazole-7-carboxylate | 914613-35-7 | C35H38N6O6 |
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1H-1,4-苯并二氮卓-2,3-二酮,7-氯-4,5-二氢-5-苯基- | 7-chloro-5-phenyl-4,5-dihydro-2H-benzodiazepine-2,3-(1H)-dione | 19554-95-1 | C15H11ClN2O2 |
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17beta-羧基-17-去氧基地塞米松 | (8S,9R,10S,11S,13S,14S,16R,17S)-9-Fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthrene-17-carboxylic acid | 75262-69-0 | C21H27FO4 |
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17alpha-氰基甲基-19-去甲睾酮 | 17α-Cyanomethyl-17β-hydroxyestr-4-en-3-one | 67473-36-3 | C20H27NO2 |
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17R-屈螺酮 | 3-(17β-hydroxy-6β,7β;15β,16β-dimethylene-3-oxo-4-androstene-17β-yl)propionic acid γ-lactone | 90457-65-1 | C24H30O3 |
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17-苯基三聚前列腺素F2α-甲基酰胺 | (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(E,3S)-3-hydroxy-5-phenylpent-1-enyl]cyclopentyl]-N-methylhept-5-enamide | 155206-01-2 | C24H35NO4 |
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17-Beta-雌二醇 3-甲醚 | 3-methoxy-estra-1,3,5(10)-triene-16α,17β-diol | 1474-53-9 | C19H26O3 |
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