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 |
|---|---|---|---|---|
| 阿托伐他汀环(氟苯基)钠盐杂质 | ATV-FX1 sodium salt | 1315629-79-8 | C33H34FN2NaO7 |
|
| 阿托伐他汀杂质D | 3-<(4-fluorophenyl)carbonyl>-2-(2-methyl-1-oxopropyl)-N,3-diphenyl-2-oxiranecarboxamide | 148146-51-4 | C26H22FNO4 |
|
| 阿托伐他汀杂质7 | (3R,5R)-7-[5-(4-Fluoro-phenyl)-3-isopropyl-2-oxo-4-phenyl-3-phenylcarbamoyl-2,3-dihydro-pyrrol-1-yl]-3,5-dihydroxy-heptanoic acid | 906552-18-9 | C33H35FN2O6 |
|
| 阿托伐他汀杂质5 | (4R-cis)-1,1-Dimethylethyl 6-[2[2-(fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]ethyl]-2,2-dimethyl-1,3-dioxane-4-acetate | 1099474-28-8 | C40H47FN2O5 |
|
| 阿托伐他汀杂质1 | Atorvastatin, (3S,5R)- | 887324-52-9 | C31H37N2O5Pol |
|
| 阿托伐他汀叔丁酯 | (3R,5R)-7-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-phenylcarbamoylpyrrol-1-yl]-3,5-dihydroxyheptanoic acid t-butyl ester | 134395-00-9 | C37H43FN2O5 |
|
| 阿托伐他汀内酯 | atorvastatin lactone | 125995-03-1 | C33H33FN2O4 |
|
| 阿托伐他汀USP相关物质E | (-)-Atorvastatin | 501121-34-2 | C33H35FN2O5 |
|
| 阿托伐他汀3-羟基消除杂质 | (2E,5S)-7-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrol-1-yl]-5-hydroxyhept-2-enoic acid | 1105067-93-3 | C33H33FN2O4 |
|
| 阿托伐他汀3-氧杂质 | 3-oxo atorvastatin | 887196-30-7 | C33H33FN2O5 |
|
| 阿扑长春胺 | apovincamine | 4880-92-6 | C21H24N2O2 |
|
| 阿扎胞苷杂质37 | 1-(β-L-ribofuranosyl)-5-azacytosine | 206269-46-7 | C8H12N4O5 |
|
| 阿扎胞苷杂质31 | 2,3,5-tri-O-acetyl-β-D-ribofuranose | 65024-85-3 | C11H16O8 |
|
| 阿扎胞苷杂质-2 | 1-β-D-Ribofuranosyl-3-guanylharnstoff | 2508-80-7 | C7H14N4O5 |
|
| 阿扎胞苷杂质-1 | N-[(N'-Formylcarbamimidoyl)carbamoyl]-D-ribofuranosylamine | 686299-20-7 | C8H14N4O6 |
|
| 阿戈美拉汀杂质醇(A) | 7-methoxy-1,2,3,4-tetrahydro-1-naphthol | 32820-10-3 | C11H14O2 |
|
| 阿戈美拉汀杂质05 | N-[2-(7-methoxy-3,4-dihydro-naphthalen-1-yl)ethyl]acetamide | 1352139-51-5 | C15H19NO2 |
|
| 阿戈美拉汀杂质02 | 2-(7-methoxy-3,4-dihydro-1-naphthyl)ethylamine | 1353428-89-3 | C13H17NO |
|
| 阿戈美拉汀杂质 | 7-Methoxy-tetralin-essigsaeure-(1)-amid | 92041-01-5 | C13H17NO2 |
|
| 阿戈美拉汀杂质 | N-[2-(7-methoxy-3-hydroxynaphth-1-yl)ethyl]-acetamide | 166526-99-4 | C15H17NO3 |
|
| 阿戈美拉汀二聚体乙酰胺 | N,N-bis[2-(7-methoxynaphthalen-1-yl)-ethyl]acetamide | 1385018-58-5 | C28H29NO3 |
|
| 阿德福韦酯杂质E | Ethyl Ester of 9-(2-Phosphonylmethoxyethyl)adenine | 116384-54-4 | C10H16N5O4P |
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| 阿巴卡韦相关物质D | o-Pyrimidine derivative abacavir | 1443421-69-9 | C18H21ClN10O |
|
| 阿巴卡韦相关化合物B(USP) | (1S, 4R)-(4-(2,5-diamino-6-chloro-4-pyrimidinyl)amino)-2-cyclopenten-1-methanol | 141271-12-7 | C10H14ClN5O |
|
| 阿巴卡韦杂质F | 9-((1R,4S)-4-(tert-Butoxymethyl)cyclopent-2-enyl)-N6-cyclopropyl-9H-purine-2,6-diamine | 1443421-68-8 | C18H26N6O |
|
| 阿尔法骨化醇中间体 | (1R,3aS,7aR)-4-[2-[(3S,5R)-3,5-Bis-(tert-butyl-dimethyl-silanyloxy)-2-methylene-cyclohex-(E)-ylidene]-eth-(E)-ylidene]-1-((R)-1,5-dimethyl-hexyl)-7a-methyl-octahydro-indene | 112670-85-6 | C39H72O2Si2 |
|
| 阿尔法骨化醇N-1的BETA杂质 | (5E)-1beta-hydroxyvitamin D3/(5E)-1beta-hydroxycholecalciferol | 65445-15-0 | C27H44O2 |
|
| 阿奇霉素氮氧化物 | azithromycin N-oxide | 90503-06-3 | C38H72N2O13 |
|
| 阿奇霉素杂质M | 3'-(N,N-Didemethyl)-3'-N-formylazithromycin | 765927-71-7 | C37H68N2O13 |
|
| 阿奇霉素杂质K | Azithromycin E | 612534-95-9 | C38H70N2O13 |
|
| 阿奇霉素杂质B | thioxanthene | 261-31-4 | C13H10S |
|
| 阿奇霉素杂质18 | N-[(2S,3R,4S,6R)-2-[[(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-ethyl-3,4,10-trihydroxy-13-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydropyran-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-15-oxo-1-oxa-6-azacyclopentadec-11-yl]oxy]-3-hydroxy-6-methyltetrahydropyran-4-yl]-N,4-dimethylbenzenesulfonamide | 612069-31-5 | C44H76N2O14S |
|
| 阿奇霉素杂质10 | 9-deoxo-9a-aza-9a-methyl-9a-homoerythronolide | 117693-42-2 | C22H43NO7 |
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| 阿奇霉素C(3′′-O-去甲基阿奇霉素) | Azithromycin C | 620169-47-3 | C37H70N2O12 |
|
| 阿奇霉素B | Azithromycin B | 307974-61-4 | C38H72N2O11 |
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| 阿塞那平杂质C | 5-Chloro-2,3-dihydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrol-1-one | 129385-61-1 | C17H10ClNO3 |
|
| 阿哌沙班杂质S3 | 5,6-dihydro-3-(4-morpholinyl)-1-[4-(2-oxo-6-methyl-1-piperidinyl)phenyl]-2(1H)-pyridone | 2098457-93-1 | C21H27N3O3 |
|
| 阿哌沙班杂质61 | methyl 4-mercaptobutanoate | 39257-91-5 | C5H10O2S |
|
| 阿哌沙班杂质52 | 1-(4-benzyloxy-phenyl)-7-oxo-6-[4-(2-oxo-piperidin-1-yl)-phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylic acid amide | 1620494-31-6 | C31H29N5O4 |
|
| 阿哌沙班杂质51 | 1-(4-benzyloxy-phenyl)-7-oxo-6-[4-(2-oxo-piperidin-1-yl)-phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylic acid ethyl ester | 1620494-29-2 | C33H32N4O5 |
|
| 阿哌沙班杂质26 | 6-(4-(5-chloropentanamido)phenyl)-1-(4-methoxyphenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide | 1449510-64-8 | C25H26ClN5O4 |
|
| 阿哌沙班杂质15 | 6-(4-aminophenyl)-1-(4-methoxyphenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide | 1423803-24-0 | C20H19N5O3 |
|
| 阿哌沙班杂质 | methyl 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate | 1074365-84-6 | C26H26N4O5 |
|
| 阿卡波糖杂质Ⅲ(EP杂质C)" | Acarbose impurity C | 610271-07-3 | C25H43NO18 |
|
| 阿卡波糖杂质F | K48LU8Evd5 | 83116-09-0 | C31H53NO23 |
|
| 阿卡波糖杂质D | Acarviosine-glucose | 68128-53-0 | C19H33NO13 |
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| 阿卡波糖-D-果糖杂质 | 3NR79GK5MO | 1013621-79-8 | C25H43NO18 |
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| 阿卡他定杂质3 | Alcaftadine N-Oxide | 952649-75-1 | C19H21N3O2 |
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| 阿加曲班杂质69 | (2R,4R)-1-(((1-Hydroxy-3-methyl-1,2,3,4-tetrahydroquinolin-8-yl)sulfonyl)-L-arginyl)-4-methylpiperidine-2-carboxylic acid | 107946-30-5 | C23H36N6O6S |
|
| 阿加曲班杂质6 | (2R, 4S)-1-(2S)-Argatroban | 189264-04-8 | C23H36N6O5S |
|
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