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 |
|---|---|---|---|---|
| 硫必利氧化物 | Tiapride N-oxide | 63484-11-7 | C15H24N2O5S |
|
| 硝苯地平杂质J | Nifedipine Monoamide | 114709-68-1 | C16H17N3O5 |
|
| 硝苯地平杂质H | 1,4-dihydro-2,6-dimethyl-4-(2'-nitrophenyl)-pyridine-3,5-dicarboxylic acid monomethyl ester | 74936-71-3 | C16H16N2O6 |
|
| 硝苯地平杂质21 | 6-Methyl-2,4-bis-(2-nitrophenyl)-1,2,3,4-tetrahydropyrimidin-5-carbonsaeuremethylester | 80742-11-6 | C19H18N4O6 |
|
| 硝苯啶杂质C | 2'-nitrobenzylideneacetoacetic acid methyl ester | 111304-31-5 | C12H11NO5 |
|
| 硝硫氰醚 | Cantrodifene | 19881-18-6 | C13H8N2O3S |
|
| 硝呋太尔杂质B | 1,2-bis((5-nitrofuran-2-yl)methylene)hydrazine | 736-53-8 | C10H6N4O6 |
|
| 砜吡草唑 | pyroxasulfone | 447399-55-5 | C12H14F5N3O4S |
|
| 矮牵牛素-3-O-葡萄糖 | petunidin-3-O-glucoside | 71991-88-3 | C22H23O12 |
|
| 矢车菊素-3-木糖苷 | Cyanidin 3-Xyloside | 29761-24-8 | C20H19ClO10 |
|
| 盐酸麦塞散 | methixene hydrochloride | 7081-40-5 | C20H23NS*ClH*H2O |
|
| 盐酸苯达莫司汀相关杂质4 | N1-methylbenzene-1,2,4-triamine | 60651-29-8 | C7H11N3 |
|
| 盐酸苯达莫司汀氯代二聚体杂质 | Bendamustine Chloro Dimer Impurity | 1228551-91-4 | C32H41Cl3N6O4 |
|
| 盐酸苯达莫司汀去氯二聚体杂质 | bendamustine dimer | 1391052-61-1 | C32H44N6O7 |
|
| 盐酸苯达莫司汀乙酯水解杂质 | N-Desmethylbendamustine | 41515-13-3 | C15H19Cl2N3O2 |
|
| 盐酸苯哌醇 | azacyclonol hydrochloride | 1798-50-1 | C18H21NO*ClH |
|
| 盐酸维生素B1杂质B | 3-(4-amino-pyrimidin-5-ylmethyl)-5-(2-hydroxy-ethyl)-4-methyl-thiazolium; chloride | 7770-93-6 | C11H15N4OS*Cl |
|
| 盐酸维拉帕米杂质B | D-517 hydrochloride | 1794-55-4 | C26H37ClN2O4 |
|
| 盐酸维拉帕米杂质A | 2-(3,4-Dimethoxy-phenyl)-2-isopropyl-5-methylamino-pentanenitrile; hydrochloride | 67775-97-7 | C17H26N2O2*ClH |
|
| 盐酸环苯扎林 | cyclobenzaprine hydrochloride | 6202-23-9 | C20H21N*ClH |
|
| 盐酸特拉唑嗪 | (R)-Terazosin | 109351-34-0 | C19H25N5O4 |
|
| 盐酸溴己新杂质 | 6,8-Dibromo-3-cyclohexyl-3,4-dihydro-2(1H)-quinazolinone | 21237-84-3 | C14H16Br2N2O |
|
| 盐酸氯雷他定 | isoloratadine | 170727-59-0 | C22H23ClN2O2 |
|
| 盐酸氯环嗪 | chlorocyclizine hydrochloride | 1620-21-9 | C18H21ClN2*ClH |
|
| 盐酸氮卓斯汀杂质E | (Z)-3-(4-chlorophenyl)methylidenephthalide | 105279-16-1 | C15H9ClO2 |
|
| 盐酸氨溴索环氨杂质 | (+)-A 32508 | 73220-00-5 | C16H22Br2N2O3 |
|
| 盐酸氟西汀杂质 | N-formylfluoxetine | 199188-97-1 | C18H18F3NO2 |
|
| 盐酸拉贝诺尔酮 | Labetalone hydrochloride | 96441-14-4 | C19H23ClN2O3 |
|
| 盐酸强力霉素杂质F | 2-Acetyl-2-decarbamoyldoxycycline | 122861-53-4 | C23H25NO8 |
|
| 盐酸度硫平杂质 | dosulepin hydrochloride | 897-15-4 | C19H21NS*ClH |
|
| 盐酸吐根酚碱 | Cephaeline dihydrochloride | 5853-29-2 | C28H40Cl2N2O4 |
|
| 盐酸双环维林 | dicyclomine hydrochloride | 67-92-5 | C19H35NO2*ClH |
|
| 盐酸厄洛替尼杂质SMA-1:2-氨基-4,5-双(2-甲氧基乙氧基)苯酰胺 | 2-amino-4,5-bis(2-methoxyethoxy)benzamide | 236750-62-2 | C13H20N2O5 |
|
| 盐酸厄他培南侧链对映异构体2 | Ertapenem Side Chain Enantiomer 2 HCl | 503607-49-6 | C12H14N2O3S*ClH |
|
| 盐酸匹美西林 | pivmecillinam hydrochloride | 32887-03-9 | C21H33N3O5S*ClH |
|
| 盐酸依替福林 | etilefrine hydrochloride | 943-17-9 | C10H15NO2*ClH |
|
| 盐酸伊立替康杂质20 | 1,2,6,7-tetrahydro-(20S)-camphthotecine | 870527-52-9 | C20H20N2O4 |
|
| 盐酸伊伐布雷定的杂质去甲伊伐布雷定 | N-Demethyl Ivabradine | 215935-23-2 | C26H34N2O5 |
|
| 白头翁素 | anemonin | 508-44-1 | C10H8O4 |
|
| 癸氟奋乃静 | Fluphenazine decanoate | 5002-47-1 | C32H44F3N3O2S |
|
| 番泻苷A | Sennoside | 517-43-1 | C42H38O20 |
|
| 甲苯磺酰氨基甲酸甲酯 | methyl tosylcarbamate | 14437-03-7 | C9H11NO4S |
|
| 甲磺酸齐拉西酮 | Ziprasidone Mesylate | 199191-69-0 | C22H31ClN4O7S2 |
|
| 甲磺酸沙奎拉韦 | invirase | 149845-06-7 | CH4O3S*C38H50N6O5 |
|
| 甲磺酸正丁酯 | n-butyl methanesulfonate | 1912-32-9 | C5H12O3S |
|
| 甲磺酸帕罗西汀 | paroxetine mesylate | 217797-14-3 | CH4O3S*C19H20FNO3 |
|
| 甲磺酸己酯 | n-hexyl methanesulfonate | 16156-50-6 | C7H16O3S |
|
| 甲硝唑杂质13 | N-(2-hydroxyethyl)-5-methyl-1,2,4-oxadiazole-3-carboxamide | 110578-73-9 | C6H9N3O3 |
|
| 甲硝唑杂质 | azanylideneethanaldehyde | 143508-97-8 | C2H3NO |
|
| 甲状腺素乙酯 | Thyroxine Ethyl Ester | 76353-71-4 | C17H15I4NO4 |
|
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