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 |
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尼可地尔杂质2 | 2-aminoethyl nicotinate nitrate | 88598-33-8 | C8H10N2O2*HNO3 |
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尼可地尔杂质13 | ethylene glycol monomethyl ether nicotinate | 19416-51-4 | C9H11NO3 |
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尼可地尔N-氧化物 | Nicorandil N-Oxide | 107833-98-7 | C8H9N3O5 |
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尼卡地平相关物质2 | SL 5721 | 64603-72-1 | C16H14N2O6 |
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尼卡地平杂质7 | 2-Acetyl-3-(3-nitrophenyl)-2-propenoic acid | 101072-61-1 | C11H9NO5 |
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对苯二酚硫酸钾 | bis(p-nitrophenyl) methyl phosphate | 799-87-1 | C13H11N2O8P |
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对称二异丙基脲 | 1,3-diisopropylurea | 4128-37-4 | C7H16N2O |
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对甲苯磺酸舒他西林 | Sultamicillin tosilate | 83105-70-8 | C32H38N4O12S3 |
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对甲苯磺酸羟乙酯 | 2-hydroxyethyl 4-methylbenzenesulfonate | 42772-85-0 | C9H12O4S |
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对甲氧苯乙烯基甲基酮 | 4-(p-methoxyphenyl)-3-butene-2-one | 943-88-4 | C11H12O2 |
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对叔丁基苯基1-(2,3-环氧)丙基醚 | cresyl-glicidyl ether | 2186-24-5 | C10H12O2 |
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对乙酰氨基酚杂质19 | 4,4'-dihydroxy-N,3'-biacetanilide | 98966-17-7 | C16H16N2O4 |
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对乙酰氨基酚杂质 | Bis(4-hydroxyphenyl)azanium;chloride | 1965310-24-0 | C12H12ClNO2 |
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对乙氧基甲酰苯丙醛 | ethyl 4-(3-oxopropyl)benzoate | 151864-81-2 | C12H14O3 |
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对丙胺酚 | parapropamol | 1693-37-4 | C9H11NO2 |
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对-克霉唑异构体 | clotrimazole | 23593-71-7 | C22H17ClN2 |
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富马酸沃诺拉赞杂质J | 2-phenyl-1H-pyrrole-4-carbonitrile | 122453-85-4 | C11H8N2 |
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富马酸沃诺拉赞杂质89 | 2,2-dibromo-1-(2-fluorophenyl)ethan-1-one | 1224739-02-9 | C8H5Br2FO |
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富马酸氯苯苄咯杂质B | 4-[1-(4-Chloro-phenyl)-1-phenyl-ethoxy]-1-methyl-azepane | 61771-18-4 | C21H26ClNO |
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富马酸单乙基酯钙盐 | 62008-22-4 | C6H8CaO4 |
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密灭汀A4 | milbemycin A4 | 51596-11-3 | C32H46O7 |
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孟鲁斯特杂质H | (R)-montelukast | 851755-56-1 | C34H32ClNO4S |
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孟鲁司特钠杂质9 | α,α,α',α'-Tetrachloro-m-xylene | 30430-40-1 | C8H6Cl4 |
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孟鲁司特苯乙烯 | [R-(E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-[1-(1-methyl)ethenyl]phenyl]propyl]thio]methyl]cyclopropaneacetic acid | 918972-54-0 | C35H34ClNO2S |
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孟鲁司特环丙烷乙腈 | 2-(1-((((R)-1-(3-((E)-2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propyl)sulfanyl)methyl)cyclopropyl)acetonitrile | 866923-62-8 | C35H35ClN2OS |
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孟鲁司特杂质G | 1-[[[(1R)-1-[3-[(lZ)-2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid | 774538-96-4 | C35H36ClNO3S |
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孟鲁司特杂质F | [R,E]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl) ethenyl]phenyl]-3-[2-(methylcarbonyl)phenyl] propyl]thio]methyl]cyclopropane acetic acid | 937275-23-5 | C34H32ClNO3S |
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孟鲁司特EP杂质I | alpha Hydroxy montelukast | 2045402-27-3 | C35H36ClNO4S |
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孕甾-4-烯-17Alpha,21-二醇-3,20-二酮-21-醋酸酯 | cortexolone 21-acetate | 640-87-9 | C23H32O5 |
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孕-5-烯-3,20-二酮双(环乙烯缩醛) | 5-pregnene-3,20-dione-3,20-bisethyleneketal | 7093-55-2 | C25H38O4 |
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姜烯酮 A | gingerenone A | 128700-97-0 | C21H24O5 |
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奥美沙坦甲基酮 | Olmesartan Methyl Ketone | 1227626-45-0 | C25H28N6O2 |
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奥美沙坦 | olmesartan | 144689-24-7 | C24H26N6O3 |
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奥美拉唑 | (R)-omeprazole | 119141-89-8 | C17H19N3O3S |
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奥硝唑杂质5 | 1-(2,3-epoxypropyl)-2-methyl-4-nitroimidazole | 16773-51-6 | C7H9N3O3 |
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奥硝唑杂质15 | 1-(3-Chlor-2-hydroxypropyl)-2-methyl-4,5-dinitroimidazol | 105687-87-4 | C7H9ClN4O5 |
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奥洛他定甲醛 | Discontinued | 1376615-97-2 | C21H23NO2 |
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奥洛他定杂质B | Olopatadine N-Oxide | 173174-07-7 | C21H23NO4 |
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奥洛他定杂质1 | 6,11-dihydro-11-oxodibenz[b,e]oxepin-2-carboxylic acid | 66801-40-9 | C15H10O4 |
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奥氮平相关杂质C | Olanzapine N-Oxide | 174794-02-6 | C17H20N4OS |
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奥氮平开环杂质 | 1-[[2-[(2-Aminophenyl)amino]-5-methyl-3-thienyl]carbonyl]-4-methyl-piperazine | 138564-61-1 | C17H22N4OS |
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奥氮平-D3 | Olanzapine-d3 | 786686-79-1 | C17H20N4S |
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奥替拉西钾杂质 | allantoxaidine | 60301-55-5 | C3H3N3O2 |
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奥普力农杂质A | 5-(2-aminopyridin-5-yl)-1,2-dihydro-6-methyl-2-oxo-3-pyridinecarbonitrile | 141354-29-2 | C12H10N4O |
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奥昔布宁杂质C | N-Desethyl-N-methyl oxybutynin | 1199574-70-3 | C21H29NO3 |
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奥昔布宁杂质A | alpha-Desphenyl-alpha-cyclohexenyl oxybutynin | 1199574-71-4 | C22H35NO3 |
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奥昔布宁杂质 | N-Desethyl-N-propyl Oxybutynin | 1215677-72-7 | C23H33NO3 |
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奥拉西坦杂质I | ethyl (S)-4-hydroxy-2-oxo-1-pyrrolidineacetate | 870695-39-9 | C8H13NO4 |
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奥拉帕尼杂质58 | 4-[[3-(4-acetylpiperazine-1-carbonyl)-4-fluorophenyl]methyl]-2H-phthalazin-1-one | 848136-41-4 | C22H21FN4O3 |
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奥拉帕利杂质31 | [4-(Cyclopropanecarbonyl)piperazin-1-yl]-cyclopropylmethanone | 458535-34-7 | C12H18N2O2 |
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