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 |
|---|---|---|---|---|
| 利伐沙班杂质41 | (S)-4-[4-[(3-amino-2-hydroxypropyl)amino]phenyl]-3-morpholinone | 1403383-56-1 | C13H19N3O3 |
|
| 利伐沙班杂质4 | (S)-N-[{3-(4-(3-oxomorpholin-4-yl)phenyl)-2-oxo-1,3-oxazolidin-5-yl}methyl]acetamide | 1429334-00-8 | C16H19N3O5 |
|
| 利伐沙班杂质29 | N-[(2R)-2-hydroxy-3-{[4-(3-oxomorpholin-4-yl)phenyl]amino}propyl]acetamide | 1429334-02-0 | C15H21N3O4 |
|
| 利伐沙班杂质27 | 2-((2R)-2-hydroxy-3-{[4-(3-oxomorpholin-4-yl)phenyl]amino}propyl)-1H-isoindole-1,3(2H)-dione | 1369969-44-7 | C21H21N3O5 |
|
| 利伐沙班杂质25 | 2-({4-[(5S)-5-({[(5-chloro-2-thienyl)carbonyl]amino}methyl)-2-oxo-1,3-oxazolidin-3-yl]phenyl}-amino)ethoxyacetic acid hydrochloride | 931117-61-2 | C19H20ClN3O6S*ClH |
|
| 利伐沙班杂质18 | 2-[2-({4-[(5S)-5-{[(5-chlorothiophen-2-yl)formamido]methyl}-2-oxo-1,3-oxazolidin-3-yl]phenyl}amino)ethoxy]acetic acid | 931204-39-6 | C19H20ClN3O6S |
|
| 利伐沙班杂质151 | 1H-isoindole-1,3(2H)-dione, 2-[(2S)-2,3-dihydroxypropyl] | 119835-88-0 | C11H11NO4 |
|
| 利伐沙班异构体杂质 | N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)formamide | 1616563-62-2 | C15H17N3O5 |
|
| 利伐沙班4 | 2-({(5R)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)-1H-isoindole-1,3(2H)-dione | 1424944-35-3 | C22H19N3O6 |
|
| 决奈达隆杂质 | (5-amino-2-butyl-1-benzofuran-3-yl)(4-hydroxyphenyl)methanone | 1278585-68-4 | C19H19NO3 |
|
| 内向-3-氨基-9-甲基-9-氮杂双环[3,3,1]壬烷 | 3-amino-9-methyl-9-azabicyclo[3.3.1]nonane | 76272-56-5 | C9H18N2 |
|
| 共轭的谷胱甘肽-S-对乙酰氨基酚 | acetaminophen-glutathione | 64889-81-2 | C18H24N4O8S |
|
| 兰索拉唑硫醚N-氧化物 | 2-[[(3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl-1-oxide)methyl]sulfanyl]-1H-benzoimidazole | 163119-30-0 | C16H14F3N3O2S |
|
| 兰索拉唑杂质G | 2-(((4-nitro-3-methyl-2-pyridyl)methyl)sulfinyl)benzimidazole | 142384-07-4 | C14H12N4O3S |
|
| 兰地洛尔杂质 | 57ZE55RV6R | 190601-22-0 | C19H29N3O6 |
|
| 六甲氧苄嗪 | N,N-[(2,3,4-trimethoxyphenyl)dimethyl]piperazine | 1257-19-8 | C24H34N2O6 |
|
| 八-(6-溴-6-脱氧)-gamma-环糊精 | octakis(6-bromo-6-deoxy)-γ-cyclodextrin | 53784-84-2 | C48H72Br8O32 |
|
| 全-反式-逆视黄醇 | 4,14-Retro-retinol | 16729-22-9 | C20H30O |
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| 党参甙I | Tangshenoside I | 117278-74-7 | C29H42O18 |
|
| 克立硼罗杂质5 | 4-(3-formyl-4-(4,4,5 ,5-tetramethyl-1,3,2-dioxaborolan-2-yl)phenoxy)benzonitrile | 2141947-89-7 | C20H20BNO4 |
|
| 克林霉素(2R-CIS)-非对映异构体 | clindamycin | 1440605-46-8 | C18H33ClN2O5S |
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| 克拉霉素杂质A | 16-Hydroxyclarithromycin | 124412-58-4 | C38H69NO14 |
|
| 克拉霉素杂质 | N-Desmethyl-6-O-methylerythromycin (9E)-Oxime | 127182-43-8 | C37H68N2O13 |
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| 克拉霉素杂质 | N-Desmethyl Clarithromycin (9E)-Oxime | 101666-67-5 | C37H68N2O13 |
|
| 克拉维酸盐EP杂质 | (2R,4R,5Z)-2-(Carboxymethyl)-5-(2-hydroxyethylidene)-3-[(2R,3Z,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carbonyl]-1,3-oxazolidine-4-carboxylic acid | 1260617-10-4 | C16H18N2O10 |
|
| 克拉红霉素EP杂质I | 3-O-descladinosylclarithromycin | 118058-74-5 | C30H55NO10 |
|
| 克拉珠利 | 2-chloro-α-(4-chlorophenyl)-4-(4,5-dihydro-3,5-dioxo-1,2,4-triazin-2(3H)-yl)benzeneacetonitrile | 101831-36-1 | C17H10Cl2N4O2 |
|
| 克尼托喹 | desethylhydroxychloroquine | 4298-15-1 | C16H22ClN3O |
|
| 光黃素 | lumiflavin | 1088-56-8 | C13H12N4O2 |
|
| 光甾醇 | lumisterol | 474-69-1 | C28H44O |
|
| 倍他米松杂质5 | Betamethasone 21-(ethyl carbonate) | 52619-05-3 | C25H33FO7 |
|
| 倍他米松EP杂质I | 8-Fluoro-11beta,17,21-trihydroxy-16beta-methyl-8alpha,9beta-pregna-1,4-diene-3,20-dione | 185613-69-8 | C22H29FO5 |
|
| 倍他米松EP杂质H | 14-Fluoro-11beta,17,21-trihydroxy-16beta-methyl-8alpha,9beta,14beta-pregna-1,4-diene-3,20-dione | 185613-71-2 | C22H29FO5 |
|
| 倍他米松EP杂质F | 17,21-Dihydroxy-16beta-methylpregna-1,4,11-triene-3,20-dione | 330157-04-5 | C22H28O4 |
|
| 倍他米松9,11-环氧化物21-丙酸酯 | (9β,11β,16β)-9,11-epoxy-17-hydroxy-16-methyl-21-(1-oxopropoxy)pregna-1,4-diene-3,20-dione | 205105-83-5 | C25H32O6 |
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| 倍他米松17-丙酸酯21-甲磺酸酯 | betamethasone 17-propanoate 21-mesylate | 15423-80-0 | C26H35FO8S |
|
| 倍他米松 17-苯甲酸酯 | betamethasone benzoate | 22298-29-9 | C29H33FO6 |
|
| 依鲁替尼杂质6 | 1,3-bis((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)propan-1-one | 1987905-93-0 | C47H46N12O3 |
|
| 依鲁替尼杂质37 | 3-iodo-1-(piperidin-4-yl)-1H-pyrazolo[3,4-d]pyrimidin-4-amine | 330793-49-2 | C10H13IN6 |
|
| 依鲁替尼杂质 | 4-(pyridin-2-ylmethoxy)-phenylamine hydrochloride | 936351-48-3 | C12H12N2O*ClH |
|
| 依鲁替尼代谢物 | Pci-45227 | 1654820-87-7 | C25H26N6O4 |
|
| 依那普利杂质1 | enalapril | 76420-74-1 | C20H28N2O5 |
|
| 依达拉奉杂质DO | 4-Hydroxy-3-methyl-1-phenyl-2-pyrazolin-5-on | 5393-61-3 | C10H10N2O2 |
|
| 依达拉奉杂质12 | (E)-ethyl 3-(2-phenylhydrazono)butanoate | 2061958-41-4 | C12H16N2O2 |
|
| 依达拉奉杂质 | 2-(3-methyl-5-oxo-1-phenyl-4,5-dihydro-1H-pyrazol-4-yl)-2-sulfopropanoic acid | 1357477-99-6 | C13H14N2O6S |
|
| 依达拉奉杂质 | 3-acetoxy-crotonic acid ethyl ester | 29214-62-8 | C8H12O4 |
|
| 依达拉奉三聚体 | 4,4-Bis-(3-methyl-phenyl-pyrazolin-5-on-4-yl)-3-methyl-1-phenyl-pyrazolin-5-on | 68195-63-1 | C30H26N6O3 |
|
| 依诺沙星杂质3 | 7-chloro-1-ethyl-6-fluoro-1,4-dihydro-4-oxo-1,8-naphthyridine-3-carboxylic acid | 79286-73-0 | C11H8ClFN2O3 |
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| 依西美坦杂质B(EP) | 6-hydroxymethyl-androsta-1,4-diene-3,17-dione | 184972-09-6 | C20H26O3 |
|
| 依维莫司杂质3 | (S)-1-{2-[(2R,3R,6S)-6-((3E,5E,7E)-(2S,9S,11R)-2,13-Dimethoxy-3,9,11-trimethyl-12-oxo-trideca-3,5,7-trienyl)-2-hydroxy-3-methyl-tetrahydro-pyran-2-yl]-2-oxo-acetyl}-piperidine-2-carboxylic acid | 147438-30-0 | C32H49NO9 |
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