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 |
|---|---|---|---|
| 托法替尼杂质N | N-((3S,4S)-1-benzyl-4-methylpiperidin-3-yl)-N-methyl-7H-pyrro-lo[2,3-d]pyrimidin-4-amine | 1252883-90-1 | C20H25N5 |
| 托法替尼杂质7 | N-[(3R,4R)-1-benzyl-4-methylpiperidin-3-yl]-2-chloro-N-methyl-7H-pyrrolo[2,3-d]pyrimidine-4-amine | 923036-25-3 | C20H24ClN5 |
| 托法替尼杂质29 | 3-((3R,4R)-4-methyl-3-(methyl((7H-pyrrolo[2,3-d]pyrimidine-4-yl))amino)piperidin-1-yl)-3-oxopropionic acid methyl ester | 1616761-01-3 | C17H23N5O3 |
| 托法替尼杂质 | butyl 3-[(3R,4R)-4-methyl-3-[methyl({7H-pyrrolo[2,3-d]pyrimidin-4-yl})amino]piperidin-1-yl]-3-oxopropanoate | 2227199-31-5 | C20H29N5O3 |
| 托法替尼 intB3 | N-((3R,4R)-1-benzyl-4-methylpiperidin-3-yl)-N-methyl-7-tosyl-7H-pyrrolo[2,3-d]pyrimidin-4-amine | 923036-30-0 | C27H31N5O2S |
| 托泊替康醋酸盐; 醋酸拓扑替康; 4-乙基-4,9-二羟基-10-[(二甲基氨基)甲基]-1H-吡喃并[3',4':6,7]中氮茚并[1,2-b]喹啉-3,14(4H,12H)-二酮醋酸盐 | topotecan acetate | 123948-88-9 | C2H4O2*C23H23N3O5 |
| 托拉菌素B | Tulathromycin B | 280755-12-6 | C41H79N3O12 |
| 托匹司他杂质21 | 4-(5-(Pyridin-4-yl)-1,3,4-oxadiazol-2-yl)picolinonitrile | 2044704-74-5 | C13H7N5O |
| 托匹司他杂质2 | N'-[imino(pyridin-4-yl)methyl]pyridine-4-carbohydrazide | 445218-61-1 | C12H11N5O |
| 托匹司他I杂质 | 3,5-di(pyridin-4-yl)-1,2,4-triazole | 4329-78-6 | C12H9N5 |
| 托伐替尼杂质T | tofacitinib | 1092578-43-2 | C16H20N6O |
| 托伐替尼杂质 | 3-[(3R,4R)-3-({2-chloro-7H-pyrrolo[2,3-d]pyrimidin-4-yl}(methyl)amino)-4-methylpiperidin-1-yl]-3-oxopropanenitrile | 1616761-00-2 | C16H19ClN6O |
| 托伐普坦杂质8 | 7-chloro-2,3-dihydro-1H-benzo[b]azepine | 1316312-24-9 | C10H10ClN |
| 扑尔敏杂质 | 2-[(4-chlorophenyl)(hydrazono)methyl]pyridine | 78539-96-5 | C12H10ClN3 |
| 截短侧耳素 | pleuromutilin | 125-65-5 | C22H34O5 |
| 戊间甲酚杂质1 | Amylmetacresol | 876473-73-3 | C12H18O |
| 恶拉戈利杂质25 | (R)-tert-butyl (2-(5-(2-fluoro-3-hydroxyphenyl)-3-(2-fluoro-6-(trifluoromethyl)benzyl)-4-methyl-2,6-dioxo-2,3-dihydropyrimidine-1(6H)-yl)-1-phenylethyl)carbamate | 1062642-68-5 | C32H30F5N3O5 |
| 恩诺沙星杂质E(EP) | 6-Chloro-1-cyclopropyl-7-(4-ethylpiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid | 1369495-59-9 | C19H22ClN3O3 |
| 恩诺沙星杂质C(EP)标准品 | Desfluoroenrofloxacin | 138892-82-7 | C19H23N3O3 |
| 恩格列净杂质37 | (S)-4-chloro-3-hydroxybutyric acid | 106941-19-9 | C4H7ClO3 |
| 恩格列净杂质35 | (2-chloro-5-iodophenyl)(4-hydroxyphenyl)methanone | 1459754-40-5 | C13H8ClIO2 |
| 恩杂鲁胺杂质J | enzalutamide | 1242137-18-3 | C21H16F4N4O3 |
| 恩替卡韦相关物质A | 6-O-Benzyl-4-dehydroxy-4-diMethylphenylsilyl Entecavir | 649761-24-0 | C27H31N5O2Si |
| 恩替卡韦杂质14 | Furoentecavir | 1984788-96-6 | C12H15N5O4 |
| 恩他卡朋酸 | (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)acrylic acid | 160391-70-8 | C10H6N2O6 |
| 恩他卡朋杂质71 | (2E)-2-Cyano-3-(3,4-dihydroxyphenyl)-N,N-diethyl-2-propenamide | 1217439-96-7 | C14H16N2O3 |
| 恩他卡朋杂质7 | ethyl (2E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)prop-2-enoate | 1215039-66-9 | C12H10N2O6 |
| 得米地曲外消旋体 | demiditraz racemate | 944263-08-5 | C13H16N2 |
| 异鼠李素-7-O-Β-D-葡萄糖苷 | isorhamnetin 7-O-β-D-glucopyranoside | 6743-96-0 | C22H22O12 |
| 异鼠李素-3,7-O-二葡萄糖苷 | isorhamnetin 3,7-O-di-β-D-glucopyranoside | 6758-51-6 | C28H32O17 |
| 异速甾醇3 | all-trans-9,10-seco-5(10),6,8(14)-cholestatrien-3β-ol | 22350-43-2 | C27H44O |
| 异维生素D3 | all-trans-9,10-seco-1(10),5,7-cholestatrien-3β-ol | 42607-12-5 | C27H44O |
| 异甲硝唑 | 1-(2-hydroxyethyl)-2-methyl-4-nitro-1H-imidazole | 705-19-1 | C6H9N3O3 |
| 异甲基硫 | isomalathion | 3344-12-5 | C10H19O6PS2 |
| 异甘草素-4'-O-芹糖(1→2)葡萄糖苷 | isoliquiritigenin-4'-O-β-D-apiosylglucoside | 29913-71-1 | C26H30O13 |
| 异牡荆素-2''-O-葡萄糖苷 | isovitexin-2''-O-β-D-glucopyranoside | 60767-80-8 | C27H30O15 |
| 异烟酸-(2,6-二甲基苯胺) | N-(2,6-dimethylphenyl)pyridine-4-carboxamide | 68280-05-7 | C14H14N2O |
| 异浙贝甲素 | isoverticine | 23496-43-7 | C27H45NO3 |
| 异氧化前胡内酯 | isooxypeucedanin | 5058-15-1 | C16H14O5 |
| 异构环孢菌素A | 30-ethyl-34-hex-4-en-2-yl-4,7,10,12,15,19,25,28-octamethyl-33-(methylamino)-6,9,18,24-tetrakis(2-methylpropyl)-3,21-di(propan-2-yl)-1-oxa-4,7,10,13,16,19,22,25,28,31-decazacyclotetratriacontane-2,5,8,11,14,17,20,23,26,29,32-undecone | 59865-16-6 | C62H111N11O12 |
| 异更昔洛韦 | 9-(2,3-dihydroxy-1-propoxymethyl)guanine | 86357-09-7 | C9H13N5O4 |
| 异异丙嗪盐酸盐 | N,N,β-trimethyl-10H-phenothiazine-10-ethanamine hydrochloride | 5568-90-1 | C17H20N2S*ClH |
| 异嘌呤醇杂质F | ethyl (4-ethoxycarbonyl-5-pyrazolyl)aminomethylenecyanoacetate | 321571-07-7 | C12H14N4O4 |
| 异丙碘胺 | isopropamide iodide | 71-81-8 | C23H33N2O*I |
| 异丙基肾上腺酮盐酸盐; 3',4'-二羟基-alpha-(异丙基氨基)苯乙酮盐酸盐 | Isoproterenone hydrochloride | 16899-81-3 | C11H15NO3*ClH |
| 异丙基甲基4-(2,1,3-苯并恶二唑-4-基)-2,6-二甲基-3,5-吡啶二羧酸酯 | 4-Benzo[1,2,5]oxadiazol-4-yl-2,6-dimethyl-pyridine-3,5-dicarboxylic acid 3-isopropyl ester 5-methyl ester | 116169-18-7 | C19H19N3O5 |
| 异丙基氨盐酸盐 | isopropylamine hydrochloride | 15572-56-2 | C3H10N*Cl |
| 异丙基2-异丙基苯基醚 | 1-isopropoxy-2-isopropylbenzene | 14366-59-7 | C12H18O |
| 异丙基(1S)-(+)-10-樟脑硫酸盐 | (1S)-(7,7-dimethyl-2-oxobicyclo[2.2.1]hept-1-yl)methane sulfonic acid iso-propyl ester | 247078-58-6 | C13H22O4S |
| 异丙嗪杂质C | rac N-Demethyl Promethazine Hydrochloride | 60113-77-1 | C16H19ClN2S |
联系我们
关注我们
公众号
