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 |
|---|---|---|---|---|
| 雷莫司琼杂质13 | (1H-Benzoimidazol-5-yl)-(1-methyl-1H-indol-3-yl)-methanone | 183613-77-6 | C17H13N3O |
|
| 雷莫司琼杂质12 | 3a,7a-Dihydroxy-5-(1-methyl-1H-indole-3-carbonyl)-octahydro-benzoimidazol-2-one | 171967-74-1 | C17H19N3O4 |
|
| 雷米普利甲酯 | Ramipril Methyl Ester | 108313-11-7 | C22H30N2O5 |
|
| 雷沙吉兰杂质5 | 1-propargylaminoindan-3-one mesylate | 1312077-04-5 | CH4O3S*C12H11NO |
|
| 雷沙吉兰杂质4 | N-2-propene-1-yl-3-chloro-trans-(R)-aminoindan | 1175018-79-7 | C12H14ClN |
|
| 雷沙吉兰杂质3 | N-2-propene-1-yl-3-chloro-cis-(R)-aminoindan | 1175018-74-2 | C12H14ClN |
|
| 雷替曲塞杂质1 | 6-(hydroxymethyl)-2-methyl-1,4-dihydroquinazolin-4-one | 1378372-01-0 | C10H10N2O2 |
|
| 雷尼替丁杂质I | 2,2'-Methylenebis(N-(2-(((5-((dimethylamino)methyl)furan-2-yl)methyl)sulfanyl)ethyl)-N'-methyl-2-nitroethene-1,1-diamine) | 207592-21-0 | C27H44N8O6S2 |
|
| 雷尼替丁杂质 | N-(2-(((5-((Dimethylamino)methyl)furan-2-yl)methyl)sulfanyl)ethyl)-2-nitroacetamide | 117846-02-3 | C12H19N3O4S |
|
| 雷尼替丁杂质 | 1,1'-(furan-2,5-diyl)bis(N,N-dimethylmethylamine) hydrochloride | 94167-82-5 | C10H18N2O |
|
| 雷尼替丁EP杂质J | 1,1'-N-(Methylenebis(sulfanediylethylene))bis(N'-methyl-2-nitroethene-1,1-diamine) | 1331637-48-9 | C11H22N6O4S2 |
|
| 雷兜甙E | rebaudioside E | 63279-14-1 | C44H70O23 |
|
| 雪胆素乙 | 22,23-dihydrocucurbitacin F | 50298-90-3 | C30H48O7 |
|
| 雌甾-4-烯-17-酮 | 4-Estren-17-one | 3646-28-4 | C18H26O |
|
| 雌甾-1,3,5,9(11)-四烯-3,16a,17b-三醇 | 9,11-Didehydrooestriol | 246021-20-5 | C18H22O3 |
|
| 雌甾-1,3,5(10)-三烯-3,17beta-二醇 17-丁酸酯 | 1,3,5(10)-Estratriene-3,17β-diol 17-propionate | 18069-79-9 | C22H30O3 |
|
| 雌二醇杂质1 | [1S-(1alpha,3abeta,4beta,7aalpha)]-4-[2-(2,5-Dihydroxyphenyl)ethyl]octahydro-1-hydroxy-7a-methyl-5H-inden-5-one | 57780-81-1 | C18H24O4 |
|
| 雄甾-3-[(4-甲苯)磺酰]氧基-5?????酮 | 3β-tosyloxy-5α-androstan-17-one | 10429-07-9 | C26H36O4S |
|
| 雄甾-3,5-二烯-17-酮 | androsta-3,5-dien-17-one | 1912-63-6 | C19H26O |
|
| 阿齐沙坦酯杂质I | methyl 1-<(2'-cyanobiphenyl-4-yl)methyl>-2,3-dihydro-2-oxo-1H-benzimidazole-7-carboxylate | 139481-33-7 | C23H17N3O3 |
|
| 阿齐沙坦杂质49 | (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-1-((2′-(4-ethyl-5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)-biphenyl-4-yl)methyl)-1H-benzo[d]imidazole-7-carboxylate | 1417576-01-2 | C32H28N4O8 |
|
| 阿齐沙坦杂质(I) | methyl 2-oxo-3-((2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl)methyl)-2,3-dihydro-1H-benzo[d]imidazole-4-carboxylate | 1403474-78-1 | C24H18N4O5 |
|
| 阿齐沙坦杂质(F) | methyl 3-amino-2-(2'-carbamoylbiphenyl-4-yl)methyl-aminobenzoate | 147404-75-9 | C22H21N3O3 |
|
| 阿齐沙坦杂质 | (5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-((2'-carbamoyl-[1,1'-biphenyl]-4-yl)methyl)-2-ethoxy-1H-benzo[d]imidazole-7-carboxylate | 1696392-12-7 | C29H25N3O7 |
|
| 阿齐沙坦杂质 | 1-((2'-cyanobiphenyl-4-yl)methyl)-2-ethoxy-1H-benzo[d]-imidazole-7-carboxylic acid | 632322-61-3 | C24H19N3O3 |
|
| 阿霉素杂质31 | (+/-)-7-epi-daunomycinone | 21794-55-8 | C21H18O8 |
|
| 阿霉素杂质2 | 7,8-dehydro-9,10-desacetyldaunorubicinone | 64845-67-6 | C19H12O6 |
|
| 阿那曲唑杂质12 | Anastrozole Acid Amide | 2469244-33-3 | C17H22N4O3 |
|
| 阿那曲唑单酸 | Anastrozole Mono Acid | 1338800-82-0 | C17H20N4O2 |
|
| 阿西莫司杂质3 | 2-Carboxy-6-methylpyrazin-4-oxid | 51037-31-1 | C6H6N2O3 |
|
| 阿西美辛叔丁基酯 | acemetacin tert-butyl ester | 75302-98-6 | C25H26ClNO6 |
|
| 阿西美辛EP杂质F | Unii-yoq76X9sxk | 76812-49-2 | C23H20ClNO8 |
|
| 阿西替尼杂质J | N-methyl-2-((3-((E)-2-(2-pyridyl)vinyl)-1-(acetyl)-1H-indazol-6-yl)thio)benzamide | 1639137-80-6 | C24H20N4O2S |
|
| 阿西替尼杂质4 | 6-[2-(methylcarbamoyl)-phenylsulfanyl]-3-E-[2-(pyridin-2-yl)ethanyl]indazole | 1443118-73-7 | C22H20N4OS |
|
| 阿西替尼杂质 | axitinib sulfone | 1348536-59-3 | C22H18N4O3S |
|
| 阿螺旋霉素 | alvespimycin | 467214-20-6 | C32H48N4O8 |
|
| 阿莫西林杂质12 | Amoxicillin open ring dimer | 73590-06-4 | C32H38N6O10S2 |
|
| 阿莫西林二氧代哌嗪 | amoxycillinpiperazine-2',5'-dione | 94659-47-9 | C16H19N3O5S |
|
| 阿莫罗芬杂质A(EP) | Amorolfine EP Impurity A | 78613-39-5 | C21H35NO2 |
|
| 阿莫曲普坦杂质1 | 3-[(2-dimethylamino)ethyl]-2-oxo-5-(1-pyrrolidinylsulfonylmethyl)-2,3-dihydroindole | 334981-13-4 | C17H25N3O3S |
|
| 阿苯达唑杂质F | methyl (6-(methylthio)-1H-benzo[d]imidazol-2-yl)carbamate | 80983-45-5 | C10H11N3O2S |
|
| 阿维菌素B1a单糖 | avermectin B1a monosaccharide | 71831-09-9 | C41H60O11 |
|
| 阿糖胞苷杂质19 | 1-α-D-ribofuranosylcytosine | 13913-16-1 | C9H13N3O5 |
|
| 阿糖胞苷杂质17 | 1-[3,4-Dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-5-hydroxypyrimidine-2,4-dione | 69321-95-5 | C9H12N2O7 |
|
| 阿糖胞苷杂质13 | Cytosine, 3-oxide | 3310-47-2 | C9H13N3O6 |
|
| 阿糖胞苷杂质10 | (Z)-3-Ureido-2-propenoic acid | 84902-98-7 | C4H6N2O3 |
|
| 阿糖胞苷EP杂质I | 1-(β-D-Arabinofuranosyl)-5-methyl-cytosin | 6829-31-8 | C10H15N3O5 |
|
| 阿糖胞苷13 | 4-(1,2,4-triazol-1-yl)-1-(2',3',5'-tri-O-acetyl-β-D-arabinofuranosyl)pyrimidine-2(1H)one | 82855-62-7 | C17H19N5O8 |
|
| 阿米卡星B | Amikacin B | 48237-20-3 | C22H44N6O12 |
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| 阿立哌唑羟基丁基杂质 | 4-(4-(2,3-dichlorophenyl)piperazin-1-yl)butan-1-ol | 870765-38-1 | C14H20Cl2N2O |
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