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 |
|---|---|---|---|---|
| 氟比洛芬杂质 | 3',3''-difluoro-[1,1';4',1'';4'',1''']quaterphenyl | 1206101-29-2 | C24H16F2 |
|
| 氟桂利嗪杂质2 | 1,4-Dicinnamylpiperazin | 88172-16-1 | C22H26N2 |
|
| 氟替卡松杂质16 | GW694301X | 397864-63-0 | C26H28F2O7 |
|
| 氟替卡松丙酸酯USP杂质D | 6α,9α-difluoro-11β-hydroxy-17β-<(methylthio)carbonyl>-17α-(propionyloxy)-16α-methylandrosta-1,4-dien-3-one | 73205-13-7 | C25H32F2O5S |
|
| 氟曲马唑 | flutrimazole | 119006-77-8 | C22H16F2N2 |
|
| 氟康唑杂质K | 2-(2-Fluorophenyl)-1,3-di(1h-1,2,4-triazol-1-yl)propan-2-ol | 1348664-75-4 | C13H13FN6O |
|
| 氟康唑杂质H | 1-Bromo-2-(2,4-difluorophenyl)-3-(1H-1,2,4-triazol-1-yl)propan-2-ol | 150194-52-8 | C11H10BrF2N3O |
|
| 氟康唑杂质A:氟康唑USP杂质A | 2-[2-fluoro-4-(1H-1,2,4-triazol-1-yl)phenyl]-1,3-bis(1H-1,2,4-triazol-)-2-propanol | 871550-15-1 | C15H14FN9O |
|
| 氟康唑杂质5 | 1-(2,4-difluorophenacyl)-4-amino-(1H-1,2,4-triazolium) chloride | 154534-83-5 | C10H9F2N4O*Cl |
|
| 氟康唑杂质 | 2-(2,4-difluorophenyl)-1-(1H-1,2,4,-triazol-1-yl)ethen-2-ol | 1449785-88-9 | C10H7F2N3O |
|
| 氟康唑杂质 | 1-(2,4-difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)ethanol | 206050-23-9 | C10H9F2N3O |
|
| 氟康唑EP杂质I | 4-Amino-1-2-(2,4-difluorophenyl)-2-hydroxy-3(1H-1,2,4-triazol-1-yl)propyl)-4H-1,2,4-triazolium ion | 749821-19-0 | C13H14F2N7O+ |
|
| 氟伐他汀杂质 | Fluvastatin N-ethyl sodium | 93936-64-2 | C23H23FNNaO4 |
|
| 氟伐他汀中间体 | (E)-(3R,5S)-(+)-7-[3-(4-fluoro-phenyl)-1-isopropyl-1H-indol-2-yl]-3,5-dihydroxy-hept-6-enoic acid 1,1-dimethylethyl ester | 194934-96-8 | C28H34FNO4 |
|
| 氟伐他汀EP杂质F | Fluvastatin hydroxydiene free acid | 1207963-21-0 | C24H24FNO3 |
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| 氟伐他汀EP杂质E | 6-{2-[3-(4-Fluorophenyl)-1-(propan-2-yl)-1H-indol-2-yl]ethenyl}-4-hydroxy-5,6-dihydro-2H-pyran-2-one | 920275-10-1 | C24H22FNO3 |
|
| 氟伐他汀EP杂质D | rac 5-Keto Fluvastatin | 1160169-39-0 | C24H24FNO4 |
|
| 毛地黄毒苷-TETRA-毛地黄毒糖苷 | Digoxoside | 31539-05-6 | C47H74O17 |
|
| 毛地黄杂质E | 3-[3-[5-[5-(4,5-dihydroxy-6-methyloxan-2-yl)oxy-4-hydroxy-6-methyloxan-2-yl]oxy-4-hydroxy-6-methyloxan-2-yl]oxy-12,14,16-trihydroxy-10,13-dimethyl-1,2,3,4,5,6,7,8,9,11,12,15,16,17-tetradecahydrocyclopenta[a]phenanthren-17-yl]-2H-furan-5-one | 52589-12-5 | C41H64O15 |
|
| 比索洛尔杂质4 | 4-(2,3-epoxy)propyloxybenzaldehyde | 14697-49-5 | C10H10O3 |
|
| 比索洛尔杂质17 | O-(Desisopropyl) bisoprolol acid | 109791-19-7 | C15H23NO5 |
|
| 比索洛尔杂质12 | N-[2-hydroxy-3-(p-2-isopropoxyethoxymethylphenoxy)-propyl]-N-isopropyl-acetamide | 66722-65-4 | C20H33NO5 |
|
| 比索洛尔EP杂质B | 1-[4-[(2-Propoxyethoxy)methyl]phenoxy]-3-(isopropylamino)-2-propanol | 1447715-44-7 | C18H31NO4 |
|
| 比沙可啶杂质2 | 4,4'-pyridin-4-ylmethanediyl-bis-phenol | 109810-81-3 | C18H15NO2 |
|
| 比沙可啶杂质1 | 4,4'-(3-pyridinylmethylene)bisphenol | 13004-51-8 | C18H15NO2 |
|
| 比拉斯汀苯乙醇中间体脱溴杂质 | 4,4-dimethyl-2-(2-phenylpropan-2-yl)oxazoline | 874895-87-1 | C14H19NO |
|
| 比拉斯汀杂质16 | methyl 2-(4-(2-(4-(1-(2-ethoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropanoate | 1181267-38-8 | C29H39N3O3 |
|
| 比拉斯汀中间体6 | 2-[1-(2-{4-[1-(4,4-dimethyl-4,5-dihydro-oxazol-2-yl)-1-methylethyl]phenyl}ethyl)piperidin-4-yl]1-(2-ethoxyethyl)-1H-benzimidazole | 202189-77-3 | C32H44N4O2 |
|
| 比拉斯汀中间体 | methyl 2-methyl-2-{4-[2-(toluene-4-sulfonyloxy)ethyl]phenyl}propanoate | 1181267-30-0 | C20H24O5S |
|
| 比拉斯汀中间体 | 2-[1-(2-{4-[1-(4,4-dimethyl-4,5-2H-oxazole-2-yl)-1-methylethyl]-phenyl}ethyl)-piperidin-4-yl]-1H-benzimidazole | 202189-81-9 | C28H36N4O |
|
| 毒毛旋花苷G | 3-[(1R,3S,5S,8R,9S,10R,11R,13R,14S,17R)-1,5,11,14-tetrahydroxy-10-(hydroxymethyl)-13-methyl-3-[(2R,3R,4R,5R,6S)-3,4,5-trihydroxy-6-methyloxan-2-yl]oxy-2,3,4,6,7,8,9,11,12,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-17-yl]-2H-furan-5-one;octahydrate | 11018-89-6 | C29H60O20 |
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| 正丁基磺酸乙酯 | ethyl 1-butanesulfonate | 2374-68-7 | C6H14O3S |
|
| 次大风子素 | Hydnocarpin | 51419-48-8 | C25H20O9 |
|
| 橙黄决明素-6-O-葡萄糖苷 | Aurantio-obtusin beta-D-glucoside | 129025-96-3 | C23H24O12 |
|
| 槐豆树脂 | ethyl 2-chloro-2-(2-phenylhydrazono)acetate | 9000-40-2 | C10H11ClN2O2 |
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| 桂利嗪EP杂质E | 1,4-Dibenzhydrylpiperazine | 56265-29-3 | C30H30N2 |
|
| 格隆溴铵杂质21 | (S)-α-cyclopentyl-α-hydroxy-α-phenylacetic acid | 64471-43-8 | C13H16O3 |
|
| 格隆溴铵杂质1 | tetrahydrofuran-3-yl 2-cyclopentyl-2-hydroxy-2-phenylacetate | 1404453-75-3 | C17H22O4 |
|
| 格隆溴铵杂质 | (2R)-2-cyclopentyl-2-hydroxy-2-phenylacetic acid | 64471-45-0 | C13H16O3 |
|
| 格隆溴铵杂质 | (3S,2'S)-3-[(cyclopentyl-hydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide | 201667-20-1 | Br*C19H28NO3 |
|
| 格拉司琼相关物质C | N-[(1R,3R,5S)-9-Azabicyclo[3.3.1]non-3-yl]-1-methyl-1H-indazole-3-carboxamide hydrochloride | 141136-01-8 | C17H23ClN4O |
|
| 格拉司琼相关物质A | 1-Desmethyl 2-Methyl Granisetron (Granisetron Impurity A) | 127472-42-8 | C18H24N4O |
|
| 核黄素杂质B | Riboflavin 3',5'-bisphosphate | 86108-26-1 | C17H22N4O12P2 |
|
| 柴胡甙元A | 4,8a-Bis(hydroxymethyl)-4,6a,6b,11,11,14b-hexamethyl-1,2,3,4a,5,6,7,8,9,10,12,14a-dodecahydropicene-3,8-diol | 5092-09-1 | C30H48O4 |
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| 柠檬苦素17-beta-D-吡喃葡萄糖苷 | Limonin 17-beta-D-glucopyranoside | 123564-61-4 | C32H42O14 |
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| 柚皮苷4'-葡萄糖苷 | Naringin 4'-glucoside | 17257-21-5 | C33H42O19 |
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| 柔红酮 | (+)-Daunomycinone | 21794-55-8 | C21H18O8 |
|
| 枸橼酸沃克拉丁 | Dorex | 52432-72-1 | C6H8O7*C20H33NO3 |
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| 来那度胺杂质3 | 2-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)glutaric acid | 295357-66-3 | C13H14N2O5 |
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| 来那度胺杂质2 | Methyl 5-amino-4-(4-amino-1-oxoisoindolin-2-yl)-5-oxopentanoate | 1198299-53-4 | C14H17N3O4 |
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