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 |
|---|---|---|---|---|
| 异丁基西地那非 | Isobutyl Sildenafil | 1391053-95-4 | C23H32N6O4S |
|
| 开环紫杉醇氧杂环丁烷d3-乙酰基4-苯甲酰基 | Paclitaxel Oxetane Ring-Opened 3-Acetyl 4-Benzoyl Impurity | 932042-85-8 | C47H53NO15 |
|
| 度鲁特韦杂质7 | Desdifluoro dolutegravir | 2244161-71-3 | C20H21N3O5 |
|
| 度鲁特韦杂质6 | dolutegravir | 1357289-29-2 | C20H19F2N3O5 |
|
| 度鲁特韦杂质16 | Fgd6spp2VH | 1357289-37-2 | C20H19F2N3O5 |
|
| 度鲁特韦杂质 | 4-Defluoro dolutegravir | 1863916-87-3 | C20H20FN3O5 |
|
| 度洛西汀杂质13 | duloxetine phthalamide | 199191-67-8 | C26H23NO4S |
|
| 度洛西汀EP杂质F | (S)-(+)-N-methyl-3-(1-naphthalenyloxy)-3-(3-thienyl)propanamine | 959392-22-4 | C18H19NOS |
|
| 度洛西汀EP杂质E | 2-(3-(Methylamino)-1-(thiophen-2-yl)propyl)naphthalen-1-ol | 1033803-59-6 | C18H19NOS |
|
| 帕苯达唑 | parbendazole | 14255-87-9 | C13H17N3O2 |
|
| 帕罗西汀杂质6 | (3R,4R)-4-(4-Fluorophenyl)-3-hydroxymethyl-1-methylpiperidine | 100332-12-5 | C13H18FNO |
|
| 帕罗西汀杂质45 | trans 4-(p-fluorophenyl)-3-(p-toluenesulfonyloxymethyl)-N-methylpiperidine | 1258537-32-4 | C20H24FNO3S |
|
| 帕罗西汀USPRCE | 1-methyl-4-(4-fluorophenyl)-1,2,3,6-tetrahydropyridine | 69675-10-1 | C12H14FN |
|
| 帕立骨化醇杂质D | 1R-<1α(1R*,2E,4S*),3aβ,7aα>-octahydro-1-<5-<(trimethylsilyl)oxy>-1,4,5-trimethyl-2-hexenyl>-7a-methyl-4H-inden-4-one | 95716-69-1 | C22H40O2Si |
|
| 帕立骨化醇 | paricalcitol | 131918-61-1 | C27H44O3 |
|
| 帕立中间体 | ((1R,3R)-5-((E)-2-((1R,3aS,7aR)-1-((S)-1,1-dimethoxypropan-2-yl)-7a-methyldihydro-1H-inden-4(2H,5H,6H,7H,7aH)-ylidene)ethylidene)cyclohexane-1,3-diyl)bis(oxy)bis(tertbutyldimethylsilane) | 957214-02-7 | C35H66O4Si2 |
|
| 帕瑞昔布钠杂质40 | 4-(4-chlorophenyl)-5-methyl-3-phenylisoxazole | 1448355-87-0 | C16H12ClNO |
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| 帕瑞昔布杂质K | N-[[4-[5-methyl-3-phenylisoxazol-4-yl]phenyl]sulfonyl]acetamide | 198471-06-6 | C18H16N2O4S |
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| 帕瑞昔布杂质017 | 4-(5-methyl-4-phenylisoxazol-3-yl)benzenesulfonamide | 181696-12-8 | C16H14N2O3S |
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| 帕瑞昔布中间体 | 3,4-diphenyl-4-hydrido-5-hydroxy-5-methylisoxazole | 181696-73-1 | C16H15NO2 |
|
| 帕潘立酮杂质14 | isopropyl sulfamate | 118873-18-0 | C3H9NO3S |
|
| 帕潘立酮杂质 | 3-(2-chloroethyl)-9-oxo-2-methyl-6,7,8,9-tetrahydro-4H-pyrido-[1,2-a]pyrimidin-4-one | 1138463-56-5 | C11H13ClN2O2 |
|
| 帕洛诺司琼杂质2 | (3S)-3-(1-oxo-2,4,5,6-tetrahydro-1H-benzo[de]isoquinoline-2-yl)-1-azoniabicyclo[2.2.2]octan-1-olate | 1021456-82-5 | C19H22N2O2 |
|
| 帕洛诺司琼6R-羟基杂质 | 2-(1'-azabicyclo[2.2.2]oct-3'S-yl)-6R-hydroxy-2,3,3aS,4,5,6-hexahydro-1H-benz[de]isoquinolin-1-one | 176019-33-3 | C19H24N2O2 |
|
| 帕洛诺司琼 | palonosetron | 135729-61-2 | C19H24N2O |
|
| 帕洛诺司琼 | palonosetron | 135729-56-5 | C19H22N2O |
|
| 帕泊昔布杂质117 | 6-acetyl-2-amino-8-cyclopentyl-5-methylpyrido[2,3-d]pyrimidin-7(8H)-one | 571189-64-5 | C15H18N4O2 |
|
| 帕拉米韦杂质42 | methyl (4R)-4-[(tert-butyloxycarbonyl)amino]cyclopent-1-ene-1-carboxylate | 251327-01-2 | C12H19NO4 |
|
| 帕拉米韦杂质41 | methyl (4S)-4-[(tert-butyloxycarbonyl)amino]cyclopent-1-ene-1-carboxylate | 251327-00-1 | C12H19NO4 |
|
| 帕拉米韦杂质 | Peramivir Impurity 7 HCl | 1352062-19-1 | C14H26N2O4*ClH |
|
| 帕布昔利布标准品025 | 4-(6-((6-acetyl-8-cyclopentyl-5-methyl-7-oxo-7,8-dihydropyrido[2,3-d]pyrimidin-2-yl)amino)pyridin-3-yl)piperazine-1-carbaldehyde | 2174002-16-3 | C25H29N7O3 |
|
| 帕布昔利布杂质X | 4-[6-(8-cyclopentyl-5-methyl-7-oxo-7,8-dihydropyrido[2,3-d]pyrimidin-2-ylamino)pyridin-3-yl]piperazine-1-carboxylic acid tert-butyl ester | 571189-65-6 | C27H35N7O3 |
|
| 帕布昔利布杂质E | 8-cyclopentyl-6-(1-hydroxyethyl)-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)pyrido[2,3-d]pyrimidin-7(8H)-one | 1376615-91-6 | C24H31N7O2 |
|
| 帕布昔利布杂质26(单体) | 6-acetyl-8-cyclopentyl-5-methyl-2-[5-(4-methyl-piperazin-1-yl)pyridin-2-ylamino]-8H-pyrido[2,3-d]pyrimidin-7-one | 571189-51-0 | C25H31N7O2 |
|
| 帕布昔利布杂质1 | 8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)pyrido[2,3-d]pyrimidine-7(8H)-one | 571190-22-2 | C22H27N7O |
|
| 帕唑帕尼杂质57 | N-(2-chloro-4-pyrimidinyl)-N-(3-methyl-1H-indazol-6-yl)amine | 444731-66-2 | C12H10ClN5 |
|
| 帕唑帕尼杂质32 | 5-amino-N-(5-amino-2-methylphenyl)sulfonyl-2-methylbenzenesulfonamide | 1072836-76-0 | C14H17N3O4S2 |
|
| 帕利哌酮开环杂质 | 3-{2-[4-(4-fluoro-2-hydroxybenzoyl)piperidin-1-yl]ethyl}-9-hydroxy-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one | 152542-03-5 | C23H28FN3O4 |
|
| 布美他尼杂质D | N-Desbutyl-N-(2-ethylhexyl) Bumetanide | 153012-65-8 | C21H28N2O5S |
|
| 布美他尼杂质6 | 3-(dibutylamino)-4-phenoxy-5-sulfamoylbenzoic acid | 1236290-34-8 | C21H28N2O5S |
|
| 布立西坦杂质19 | (R)-β-(2-propyl)-γ-butyrolactone | 53657-15-1 | C7H12O2 |
|
| 布立西坦杂质15 | (Z)-2-propyl-2-heptenal | 95667-14-4 | C10H18O |
|
| 布立西坦杂质10 | 3-hydroxy-2-propylheptanal | 60559-16-2 | C10H20O2 |
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| 布瓦西坦杂质60 | ethyl 3-formylhexanoate | 54374-02-6 | C9H16O3 |
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| 布瓦西坦外消旋体 | 2-(2-oxo-4-propylpyrrolidin-1-yl)butanamide | 357335-87-6 | C11H20N2O2 |
|
| 布洛芬杂质O | α-(4'-sec.Butyl-phenyl)-propionsaeure | 64451-76-9 | C13H18O2 |
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| 布洛芬杂质G(EP)标准品 | 7-(2-Methylpropyl)-1-(4-(2-methylpropyl)phenyl)-1,2,3,4-tetrahydronaphthalene-1,4-dicarboxylic acid | 1391054-15-1 | C26H32O4 |
|
| 布洛芬杂质B | (+/-)-ibuprofen | 3585-49-7 | C13H18O2 |
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| 布洛芬杂质A | Ibuprofen | 66622-47-7 | C13H18O2 |
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| 布洛芬杂质7 | 2-(isobutyl-phenyl)-propionic acid | 69363-33-3 | C13H18O2 |
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