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 |
|---|---|---|---|---|
| 阿立哌唑溴代杂质 | 7-(4-bromobutoxy) quinolin-2(1H)-one | 203395-59-9 | C13H14BrNO2 |
|
| 阿立哌唑杂质B | 7,7'-((Oxybis(butane-4,1-diyl))bis(oxy))bis(3,4-dihydroquinolin-2(1H)-one) | 1424858-02-5 | C26H32N2O5 |
|
| 阿立哌唑杂质13 | N-(4-chlorobutyl)-3,4-dihydroquinolin-2(1H)-one | 387399-03-3 | C13H16ClNO |
|
| 阿立哌唑二聚物 | Aripiprazole Dimer | 1797986-18-5 | C48H56Cl4N6O4 |
|
| 阿立哌唑N4-氧化物 | 7-{4-[4-(2,3-dichlorophenyl)-1-piperazinyl (4-N-oxo)]butoxy}3,4-dihydro-2(1H)-quinolinone | 573691-11-9 | C23H27Cl2N3O3 |
|
| 阿立哌唑N,N-二氧化物 | 7-{4-[4-(2,3-dichlorophenyl)-1-piperazinyl] (1-N, 4-N-oxo) butoxy}-3,4-dihydro-2-(1H)-quinolinone | 573691-13-1 | C23H27Cl2N3O4 |
|
| 阿立哌唑EP杂质D | 3-deschloro-aripiprazole | 203395-81-7 | C23H28ClN3O2 |
|
| 阿瑞杂质9 | 2-(R)-(1-(R)-(3,5-bis(trifluoromethyl)phenyl)ethoxy)-3-(S)-4-fluorophenyl-4-2-(N-methylcarboxyactamidrazono)morpholine | 219821-37-1 | C24H25F7N4O4 |
|
| 阿瑞吡坦杂质 | 2-[1-(3,5-bis-trifluoro-methylphenyl)ethoxy]-3-(4-fluorophenyl)morpholine | 1242175-36-5 | C20H18F7NO2 |
|
| 阿瑞匹坦非对映异构体2R3R1R | (2R,3R)-2-[(1R)-1-(3,5-bis-trifluoro-methylphenyl)ethoxy]-3-(4-fluorophenyl)morpholine | 380499-06-9 | C20H18F7NO2 |
|
| 阿瑞匹坦杂质 | 3-(hydroxymethyl)-1H-1,2,4-triazol-5(4H)-one | 24021-90-7 | C3H5N3O2 |
|
| 阿法替尼杂质J | (S,E)-4-(dimethylamino)-N-(4-oxo-7-((tetrahydrofuran-3-yl)oxy)-3,4-dihydroquinazolin-6-yl)but-2-enamide | 1456696-14-2 | C18H22N4O4 |
|
| 阿法替尼杂质77 | isopropyl 2-chloro-2-oxoacetate | 26404-20-6 | C5H7ClO3 |
|
| 阿法替尼杂质74 | (E)-Ethyl 4-(Methylamino)but-2-enoate | 1259015-90-1 | C7H13NO2 |
|
| 阿法替尼杂质73 | (E)-4-bromo-N,N-dimethylbut-2-enamide | 137131-09-0 | C6H10BrNO |
|
| 阿法替尼杂质45 | methyl trans-4-aminocrotonate | 99281-87-5 | C5H9NO2 |
|
| 阿法替尼杂质36 | 2-amino-4-fluoro-5-nitrobenzoic acid | 1194097-41-0 | C7H5FN2O4 |
|
| 阿比特龙杂质9 | 17-(4-pyridyl)androsta-5,16-dien-3β-ol | 165334-72-5 | C24H31NO |
|
| 阿比特龙杂质4 | Acetic acid (3S,8R,9S,10R,13S,14S)-17-ethyl-10,13-dimethyl-2,3,4,7,8,9,10,11,12,13,14,15-dodecahydro-1H-cyclopenta[a]phenanthren-3-yl ester | 2118-32-3 | C23H34O2 |
|
| 阿比特龙杂质10 | 3β-acetoxy-17-(4-pyridyl)androsta-5,16-diene | 165334-69-0 | C26H33NO2 |
|
| 阿比朵尔杂质 | 6,7-dibromo-4-dimethylaminomethyl-5-hydroxy-1-methyl-2-phenylsulfanyl-methyl-1H-indole-3-carboxylic acid ethyl ester | 153633-10-4 | C22H24Br2N2O3S |
|
| 阿格列汀杂质C | (R)-N-(1-(3-(2-cyanobenzyl)-1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl)piperidin-3-yl)ethanamide | 1108731-49-2 | C20H23N5O3 |
|
| 阿格列汀杂质BOC | 7HZ6W2XA64 | 1618644-31-7 | C23H29N5O4 |
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| 阿替洛尔杂质F | 2,2'-((((Isopropylazanediyl)bis(2-hydroxypropane-3,1-diyl))bis(oxy))bis(4,1-phenylene))diacetamide | 87619-83-8 | C25H35N3O6 |
|
| 阿曲库铵杂质V | (1R)-1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-2-methoxycarbonylethyl-isoquinolinium iodide | 1075726-86-1 | C25H34NO6*I |
|
| 阿曲库铵杂质O | Dvu86L2kre | 155913-31-8 | C38H49NO11S |
|
| 阿曲库铵杂质N | (R)-laudanosine | 85-63-2 | C21H27NO4 |
|
| 阿曲库铵杂质D2 | cis-(R)-1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-2-[3-[(5-hydroxypentyl)oxy]-3-oxopropyl]-6,7-dimethoxy-2-methyl-isoquinolinium besylate | 1100676-16-1 | C6H5O3S*C29H42NO7 |
|
| 阿曲库铵杂质C | 1,5-pentanediyl bis[1-[(3,4-dimethoxyphenyl)methyl]-3,4-dihydro-6,7-dimethoxy-1H-isoquinoline-2-propionate] | 64228-77-9 | C51H66N2O12 |
|
| 阿曲库铵杂质A | (1R,2R)-2-(2-carboxyethyl)-1-[(3,4-dimethoxyphenyl)methyl]-6,7-dimethoxy-2-methyl-1,2,3,4-tetrahydroisoquinolinium besylate | 1075727-06-8 | C6H5O3S*C24H32NO6 |
|
| 阿普斯特降解杂质 | (S)-4-amino-2-(1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)isoindoline-1,3-dione | 635705-72-5 | C20H22N2O6S |
|
| 阿普斯特杂质B | 1-(3,4-dimethoxyphenyl)-2-(methylsulfonyl)ethylamine | 1255909-25-1 | C11H17NO4S |
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| 阿普斯特杂质67 | 1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethenamine | 1450657-31-4 | C12H17NO4S |
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| 阿普斯特杂质29 | (S)-4-Amino-2-[1-(3,4-dihydroxy-phenyl)-2-methanesulfonyl-ethyl]-isoindole-1,3-dione | 1384439-80-8 | C17H16N2O6S |
|
| 阿普斯特杂质26 | (S)-N-{2-[1-(3-hydroxy-4-methoxy-phenyl)-2-methanesulfonyl-ethyl]-1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl}-acetamide | 1384967-20-7 | C20H20N2O7S |
|
| 阿普斯特杂质08 | (S)-N-(2-(1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)-1,3-dioxoisoindolin-5-yl)acetamide | 2201974-01-6 | C22H24N2O7S |
|
| 阿普斯特杂质 | (S)-N-(2-(1-(3-ethoxy-4-hydroxyphenyl)-2-(methylsulfonyl)ethyl)-1,3-dioxoisoindolin-4-yl)acetamide | 1384441-38-6 | C21H22N2O7S |
|
| 阿昔洛韦N-甲基-L-缬氨酸酯盐酸盐 | N-Methyl valacyclovir hydrochloride | 1346617-39-7 | C14H23ClN6O4 |
|
| 阿昔洛韦N-乙基-L-缬氨酸酯盐酸盐 | N-Ethyl valacyclovir hydrochloride | 1346617-49-9 | C15H25ClN6O4 |
|
| 阿昔洛韦L-亮氨酸 | Acyclovir L-Leucinate | 142963-69-7 | C14H23ClN6O4 |
|
| 阿托西汀EP杂质A | N-methyl-3-phenoxy-3-phenyl-1-propylamine | 56161-70-7 | C16H19NO |
|
| 阿托品杂质6 | Atropine Impurity 6 | 22226-37-5 | C17H21NO3 |
|
| 阿托伐他汀钙阿托伐他汀钙中间体1甲酯 | methyl 2-((4R,6R)-6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetate | 1353049-81-6 | C37H41FN2O5 |
|
| 阿托伐他汀钙杂质59 | ethyl 2-((4R,6R)-6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetate | 616201-27-5 | C38H43FN2O5 |
|
| 阿托伐他汀钙杂质52 | 2-((4R,6R)-6-(2-(3-(phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl)ethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetic acid isopropyl ester | 1112262-71-1 | C39H45FN2O5 |
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| 阿托伐他汀钙杂质43 | (3R,5S)-Atorvastatin Acetonide tert-Butyl Ester | 947249-30-1 | C40H47FN2O5 |
|
| 阿托伐他汀缩丙酮 | 2-((4R,6R)-6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetic acid | 581772-29-4 | C36H39FN2O5 |
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| 阿托伐他汀相关化合物E | 1105067-88-6 | C33H35CaFN2O5 |
|
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| 阿托伐他汀甲酯 | atorvastatin methyl ester | 345891-62-5 | C34H37FN2O5 |
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| 阿托伐他汀环氧乙烷杂质 | 3-(4-Fluorobenzoyl)-2-(2-methylpropyl)-N,3-diphenyloxirane-2-carboxamide | 1246818-88-1 | C26H24FNO3 |
|
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