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 |
|---|---|---|---|---|
| 多索茶碱杂质01 | 7-theophyllineacetaldehyde | 5614-53-9 | C9H10N4O3 |
|
| 多潘立酮杂质19 | 1-(3-hydroxypropyl)benzimidazolin-2-one | 62780-92-1 | C10H12N2O2 |
|
| 多替拉韦杂质5 | dolutegravir | 1309560-49-3 | C20H19F2N3O5 |
|
| 多替拉韦杂质4 | Defluoro dolutegravir | 1863916-88-4 | C20H20FN3O5 |
|
| 多巴胺杂质8 | 4,4'-(3-aza-pentanediyl)-di-pyrocatechol | 16240-59-8 | C16H19NO4 |
|
| 多奈哌齐杂质L | 4-((5,6-dimethoxy-2,3-dihydro-1H-inden-2-yl)methyl)piperidine | 844694-83-3 | C17H25NO2 |
|
| 多奈哌齐杂质-OH | 3-hydroxy-5,6-dimethoxy-2,3-dihydro-1H-inden-1-one | 148517-82-2 | C11H12O4 |
|
| 多奈哌齐杂质 | 5,6-dimethoxy-2-(pyridine-4-carbonyl)indan-1-one | 923571-15-7 | C17H15NO4 |
|
| 多奈哌齐N氧化物 | rac (cis/trans) Donepezil N-Oxide | 120013-84-5 | C24H29NO4 |
|
| 多奈哌齐2 | 5,6-dimethoxy-1H-indene-1,3(2H)-dione | 36517-91-6 | C11H10O4 |
|
| 外消旋苄基苯肾上腺素 | 2-(benzyl(methyl)amino)-1-(3'-hydroxyphenyl)ethanol | 1159977-09-9 | C16H19NO2 |
|
| 外消旋去氟西酞普兰草酸盐 | 1-(3-dimethylamino-propyl)-1-phenyl-1,3-dihydro-isobenzofuran-5-carbonitrile oxalate | 1093072-86-6 | C2H2O4*C20H22N2O |
|
| 外消旋去(异丙氧乙基)-2-异丙氧基乙氧基甲基比索洛尔 | (2RS)-1-[4-[[(2-Isopropoxyethoxy)methoxy]methyl]phenoxy]-3-isopropylaminopropan-2-ol | 1215342-36-1 | C19H33NO5 |
|
| 外消旋二醋洛尔 | Diacetolol | 22568-64-5 | C16H24N2O4 |
|
| 外消旋alpha-羟基布洛芬 | 2-hydroxy-2-(4-isobutylphenyl)propanoic acid | 60057-62-7 | C13H18O3 |
|
| 外消旋N-去异丙基-N-乙基醋丁洛尔 | N-(3-Acetyl-4-(3-(ethylamino)-2-hydroxypropoxy)phenyl)butanamide | 441019-91-6 | C17H26N2O4 |
|
| 外消旋N-去丁酰基醋丁洛尔 | acetolol | 57898-80-3 | C14H22N2O3 |
|
| 外消旋4-[4-(环氧乙烷基甲氧基)-1,2,5-噻二唑-3-基]吗啉 | 4-{4-[(2R/S)-oxiran-2-ylmethoxy]-1,2,5-thiadiazol-3-yl}morpholine | 58827-68-2 | C9H13N3O3S |
|
| 外消旋-反式-4-脱氟-4-(4-氟苯基)帕罗西汀盐酸盐 | trans-3-(Benzo[1,3]dioxol-5-yloxymethyl)-4-(4'-fluoro-biphenyl-4-yl)-piperidine hydrochloride | 1217655-87-2 | C25H25ClFNO3 |
|
| 外消旋-6-甲基-4-苯基-2-色满醇 | 2-hydroxy-6-methyl-4-phenyldihydrobenzopyran | 209747-04-6 | C16H16O2 |
|
| 外消旋-11-脱氧-8(12)-去氢米索前列醇 | 7-[2-((E)-4-Hydroxy-4-methyl-oct-1-enyl)-5-oxo-cyclopent-1-enyl]-heptanoic acid methyl ester | 1331639-92-9 | C22H36O4 |
|
| 塞来考昔羧酸甲酯 | methyl 4-[1-(4-aminosulfonylphenyl)-3-(trifluoromethyl)-1H-pyrazol-5-yl]benzoate | 1189893-75-1 | C18H14F3N3O4S |
|
| 塞来昔布杂质P | 4-(5-p-methylphenyl-3-trifluoromethyl-pyrazol-1-yl)-benzenesulfonic acid | 921617-76-7 | C17H13F3N2O3S |
|
| 塞来昔布杂质E | (Z)-1,1,1-trifluoro-4-hydroxy-4-(4-methylphenyl)-but-3-en-2-one | 910303-54-7 | C11H9F3O2 |
|
| 塞来昔布杂质3 | 4-(5-phenyl-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide | 170569-87-6 | C16H12F3N3O2S |
|
| 塞来昔布杂质 | 4-[5-(2-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide | 170569-99-0 | C17H14F3N3O2S |
|
| 培黄素 | Galloflavin | 568-80-9 | C12H6O8 |
|
| 培美曲塞氧化开环杂质 | N-{4-[3-(2,6-Diamino-4-oxo-1,4-dihydropyrimidin-5-yl)-3-oxopropyl]benzoyl}-D-glutamic acid | 193281-05-9 | C19H21N5O7 |
|
| 培美曲塞杂质D | (2S)-2-[[[(4S)-4-[[4-[2-amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d]pyrimidin-5-yl]ethyl]benzoyl]amino]-4-carboxybutanoyl]amino]pentanedioic acid | 144051-68-3 | C25H28N6O9 |
|
| 培美曲塞杂质C | (2S,2'S)-2,2'-[[(5S)-2,2'-diamino-4,4',6-trioxo-1,4,4',6,7,7'-hexahydro-1'H,5H-5,6'-bipyrrolo[2,3-d]pyrimidine-5,5'-diyl]bis(ethylenebenzene-4,1-diylcarbonylimino)]dipentanedioic acid | 1802552-16-4 | C40H40N10O13 |
|
| 培美曲塞杂质B | (2S,2'S)-2,2'-[[(5R)-2,2'-diamino-4,4',6-trioxo-1,4,4',6,7,7'-hexahydro-1'H,5H-5,6'-bipyrrolo[2,3-d]pyrimidine-5,5'-diyl]bis(ethylenebenzene-4,1-diylcarbonylimino)]dipentanedioic acid | 1802552-04-0 | C40H40N10O13 |
|
| 培美曲塞二钠杂质18 | 4-((E)-3-Hydroxy-propenyl)-benzoic acid ethyl ester | 89113-43-9 | C12H14O3 |
|
| 培美曲塞二钠杂质14 | 4-carboxybenzenediazonium chloride | 17405-00-4 | C7H5N2O2*Cl |
|
| 培哚普利杂质 F | ethyl (2S)-2-[(3S,5aS,9aS,10aS)-3-methyl-1,4-dioxo-5a,6,7,8,9,9a,10,10a-octahydro-3H-pyrazino[1,2-a]indol-2-yl]pentanoate | 129970-98-5 | C19H30N2O4 |
|
| 培哚普利拉内酰胺B | Perindoprilat lactam B | 130061-28-8 | C17H26N2O4 |
|
| 埃罗替尼杂质C | 6,7-bis(2-methoxyethoxy)-4-methoxyquinazoline | 1312937-41-9 | C15H20N2O5 |
|
| 埃索美拉唑杂质B | 2-(3,5-dimethyl-2-pyridinyl)methylsulfinyl-5-methoxy-1H-benzimidazole | 110374-16-8 | C16H17N3O2S |
|
| 埃索美拉唑杂质31 | carboxyomeprazole | 120003-72-7 | C17H17N3O5S |
|
| 埃索美拉唑杂质2 | 4-CHLORO-2-HYDROXYMETHYL-3,5-DIMETHYLPYRIDINE HYDROCHLORIDE | 143016-70-0 | C8H10ClNO*ClH |
|
| 埃索美拉唑杂质19 | 5-Hydroxyesomeprazole | 358675-51-1 | C16H17N3O3S |
|
| 坎地沙坦去乙基N1三苯甲基类似物 | 1-{[(Cyclohexyloxy)carbonyl]oxy}ethyl 2-oxo-3-({2'-[1-(triphenylmethyl)-1H-tetrazol-5-yl][1,1'-biphenyl]-4-yl}methyl)-2,3-dihydro-1H-benzimidazole-4-carboxylate | 934495-65-5 | C50H44N6O6 |
|
| 坎利酮 | canrenone | 976-71-6 | C22H28O3 |
|
| 地高辛配基二(洋地黄毒糖甙) | Digoxigenin bisdigitoxide | 5297-05-2 | C35H54O11 |
|
| 地诺孕素杂质M(EP) | 17β-Cyanmethyl-4-brom-17β-hydroxy-oestra-4,9-dien-3-on | 98149-13-4 | C20H24BrNO2 |
|
| 地诺孕素EP杂质I | 17α-Cyanomethyl-13β-methyl-17β-hydroxy-gon-5(10)-en-3-on | 65928-65-6 | C20H27NO2 |
|
| 地诺孕素EP杂质H | 2-((8R,9S,13S,14S,17R)-3,17-dihydroxy-13-methyl-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthren-17-yl)acetonitrile | 16669-06-0 | C20H25NO2 |
|
| 地诺前列素氨丁三醇 | dinoprost tromethamine | 38562-01-5 | C4H11NO3*C20H34O5 |
|
| 地西他滨 | 5-aza-2'-deoxycytidine | 2353-33-5 | C8H12N4O4 |
|
| 地芬尼多杂质9 | 1,1-Diphenyl-propan-1-ol | 5180-33-6 | C15H16O |
|
| 地芬尼多杂质2 | 4-hydroxy-4,4-diphenylbutyl chloride | 63645-18-1 | C16H17ClO |
|
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