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 |
|---|---|---|---|---|
| 布地奈德杂质L | 11-Keto budesonide | 216453-74-6 | C25H32O6 |
|
| 布地奈德杂质C | Budesonide Impurity C | 1040085-99-1 | C25H34O6 |
|
| 布地奈德杂质7 | 21-Acetoxy-16α,17-dihydroxy-pregna-1,4-dien-3,11,20-trion | 3949-79-9 | C23H28O7 |
|
| 布地奈德杂质15 | 2-((4aS,4bS,5aS,6aS,7S,8R,9aS,9bS)-7,8-Dihydroxy-4a,6a-dimethyl-2-oxo-2,4a,5a,6,6a,7,8,9,9a,9b,10,11-dodecahydrocyclopenta[1,2]phenanthro[4,4a-b]oxiren-7-yl)-2-oxoethyl Acetate | 58404-37-8 | C23H28O7 |
|
| 布地奈德杂质11 | (10S,13S,16R,17S)-16,17-Dihydroxy-17-(2-hydroxy-acetyl)-10,13-dimethyl-6,7,8,10,12,13,14,15,16,17-decahydro-cyclopenta[a]phenanthren-3-one | 39672-76-9 | C21H26O5 |
|
| 布地奈德EP杂质B | NI0Agy81EG | 1040085-98-0 | C23H30O6 |
|
| 巴里替尼杂质5 | [1-(ethanesulfonyl)-3-{4-[7-(hydroxymethyl)-7H-pyrrolo[2,3-d]pyrimidin-4-yl]-1H-pyrazol-1-yl}azetidin-3-yl]acetonitrile | 1187595-89-6 | C17H19N7O3S |
|
| 巴柳氮USP杂质3 | 2'-[(1E)-2-[4-[[(2-carboxyethyl)amino]carbonyl]phenyl]diazenyl] Balsalazide | 1346606-53-8 | C27H24N6O9 |
|
| 左西替利嗪杂质20 | 2-[2-[4-(diphenylmethyl)-1-piperazinyl]ethoxy]-acetic acid | 83881-53-2 | C21H26N2O3 |
|
| 左西孟旦杂质10 | 6-(4-hydroxyphenyl)-(5R)-methyl-4,5-dihydro-3(2H)-pyridazinone | 134678-47-0 | C11H12N2O2 |
|
| 左西孟坦杂质27 | 6-(4-hydroxyphenyl)-5-methyl-4,5-dihydro-2H-pyridazin-3-one | 103416-88-2 | C11H12N2O2 |
|
| 左氧氟环合酯 | (-)-ethyl 9,10-difluoro-2,3-dihydro-3-methyl-7-oxo-7H-pyrido<1,2,3-de><1,4>benzoxazine-6-carboxylate | 106939-34-8 | C15H13F2NO4 |
|
| 左氧氟沙星相关物质C | ofloxacine ethyl ester | 177472-30-9 | C20H24FN3O4 |
|
| 左氧氟沙星杂质W | (-)-ethyl 1,4-dihydro-1-<1(S)-(hydroxymethyl)ethyl>-4-oxo-6,7,8-trifluoroquinoline-3-carboxylate | 110548-03-3 | C15H14F3NO4 |
|
| 左氧氟沙星杂质N | 9-defluoro-9-(4-methyl-1-piperazinyl)levofloxacin | 1329833-82-0 | C23H31N5O4 |
|
| 左氧氟沙星杂质K | (+)-ethyl 9,10-difluoro-2,3-dihydro-3-methyl-7-oxo-7H-pyrido<1,2,3-de><1,4>benzoxazine-6-carboxylate | 110548-06-6 | C15H13F2NO4 |
|
| 左氧氟沙星杂质I | ethyl 10-fluoro-2,3-dihydro-3-(S)-methyl-7-oxo-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylate | 431058-46-7 | C15H14FNO4 |
|
| 左氧氟沙星杂质H | 5H-Pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid, 9,10-difluoro-2,3,6,7-tetrahydro-3-methyl-7-oxo- | 1026952-91-9 | C13H11F2NO4 |
|
| 左氧氟沙星杂质22 | (S)-ethyl 6,8-difluoro-1-(1-hydroxypropan-2-yl)-7-(4-methylpiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylate | 177472-29-6 | C20H25F2N3O4 |
|
| 左氧氟沙星杂质11 | (S)-7,8-difluoro-3,4-dihydro-3-methyl-2H-1,4-benzoxazine | 106939-42-8 | C9H9F2NO |
|
| 左氧氟沙星USP杂质B | S-(-)-9-fluoro-2,3-dihydro-3-methyl-10-(1,4-diazapentyl)-7-oxo-7H-pyrido-<1,2,3-de><1,4>benzoxazine-6-carboxylic acid | 151250-76-9 | C16H18FN3O4 |
|
| 左氧氟沙星N-氧化物 | Levofloxacin N-oxide | 117678-38-3 | C18H20FN3O5 |
|
| 左氧氟沙星N-氧化物 | Ofloxacin N-oxide, (R)- | 117678-37-2 | C18H20FN3O5 |
|
| 左旋米唑EP杂质B | 2-Thiazolidinimine, 3-(2-phenylethenyl)-, (E)- | 37430-07-2 | C11H12N2S |
|
| 左旋米唑EP杂质A | 3-(beta-Aminophenethyl)-2-thiazolidinone | 32190-34-4 | C11H14N2OS |
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| 左旋甲状腺素杂质16 | 3-Monochlorotriiodothyronine | 909279-46-5 | C15H11ClI3NO4 |
|
| 左旋甲状腺素EP杂质H | 'Tetrajod-thyroameisensaeure' | 2055-97-2 | C13H6I4O4 |
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| 左旋沙丁胺醇杂质D | salbutamol aldehyde | 156339-88-7 | C13H19NO3 |
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| 左卡尼汀相关物质A | (3-carboxy-allyl)-trimethyl-ammonium; chloride | 6538-82-5 | C7H14NO2*Cl |
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| 左卡尼汀杂质C | (+/-)-carnitinamide chloride | 5261-99-4 | C7H17N2O2*Cl |
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| 左卡尼汀杂质A | Crotonsaeure-betain | 927-89-9 | C7H13NO2 |
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| 左卡尼汀杂质3 | (R)-(-)-carnitinamide chloride | 5261-99-4 | C7H17N2O2*Cl |
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| 左卡尼汀杂质2氯化物 | (3<i>t</i>-carboxy-allyl)-trimethyl-ammonium; chloride | 144205-67-4 | C7H14NO2*Cl |
|
| 左匹克隆杂质C | RP 48497 | 148891-53-6 | C11H7ClN4O |
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| 左乙拉西坦杂质B | 2-(2-Oxopyrrolidin-1-yl)but-2-enamide, (2Z)- | 358629-47-7 | C8H12N2O2 |
|
| 左乙拉西坦-D6 | Levetiracetam-D6 | 1133229-30-7 | C8H14N2O2 |
|
| 山竹子素 | Guttiferone E | 147782-04-5 | C38H50O6 |
|
| 山柰酚-3,7-二-O-葡萄糖苷 | 3,7-Di-O-glucosylkaempferol | 25615-14-9 | C27H30O16 |
|
| 尼麦角林杂质A | Chloronicergoline | 38536-28-6 | C24H26ClN3O3 |
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| 尼达尼布杂质39 | 3-chlorobenzaldehyde dimethyl acetal | 3395-80-0 | C9H11ClO2 |
|
| 尼达尼布杂质28 | N-(4-aminophenyl)-2-chloro-N-methylacetamide | 855860-75-2 | C9H11ClN2O |
|
| 尼莫地平杂质17 | 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid, 3-(2-(methyl(phenylmethyl)amino)ethyl) ester | 123973-71-7 | C25H27N3O6 |
|
| 尼群地平丙酯 | 3-methyl 5-n-propyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate | 225785-54-6 | C19H22N2O6 |
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| 尼美舒利EP杂质 | 2-Mesylamido-5-nitrophenol | 38880-53-4 | C7H8N2O5S |
|
| 尼罗替尼杂质3 | 3-(1H-imidazol-1-yl)-5-(trifluoromethyl)aniline | 943320-48-7 | C10H8F3N3 |
|
| 尼罗替尼杂质11 | N-[3-(4-ethyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-4-methyl-3-[[4-(pyridin-3-yl)pyrimidin-2-yl]amino]benzamide | 2119583-24-1 | C29H24F3N7O |
|
| 尼罗替尼杂质1 | 4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-N-[5-(2-methyl-1H-imidazol-1-yl)-3-(trifluoromethyl)phenyl]benzamide | 641571-05-3 | C28H22F3N7O |
|
| 尼罗替尼N-氧化物 | 3-(2-((2-methyl-5-((3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)aminoformyl)phenyl)amino)pyrimidin-4-yl)pyridine-1-oxide | 1246817-85-5 | C28H22F3N7O2 |
|
| 尼索地平杂质Ⅱ2,6-二甲基-4-(2-亚硝基苯基)-3,5-吡啶二羧酸甲酸甲酯异丁酯 | 2,6-Dimethyl-5-{[(3-methylbutan-2-yl)oxy]carbonyl}-4-(2-nitrosophenyl)pyridine-3-carboxylate | 87375-91-5 | C20H21N2O5- |
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| 尼洛替尼杂质3 | 3-(2-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)aniline | 641571-06-4 | C11H10F3N3 |
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