摩熵化学
数据库官网
小程序
打开微信扫一扫
首页 分子通 化学资讯 化学百科 反应查询 关于我们
请输入关键词

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
阿加曲班杂质3 N-alpha-t-butoxycarbonyl-Ng-nitro-L-arginine lactam 68319-72-2 C11H19N5O5
阿加曲班杂质13 3-Methylquinoline-5-sulfonyl chloride 94975-84-5 C10H8ClNO2S
阿伐那非杂质1 (S)-4-((3-chloro-4-methoxybenzyl)amino)-2-(2-(hydroxymethyl)pyrrolidin-1-yl)pyrimidine-5-carboxamide 372117-54-9 C18H22ClN5O3
间氟普拉格雷 5-(2-cyclopropyl-1-(3-fluorophenyl)-2-oxoethyl)-4,5,6,7-tetrahydrothieno [3,2-c]pyridin-2-yl acetate 1391194-39-0 C20H20FNO3S
间二甲苯-4,alpha,alpha'-三醇 2,4-bis(hydroxymethyl)phenol 2937-60-2 C8H10O3
间-非索非那定 meta-Fexofenadine 479035-75-1 C32H39NO4
门冬氨酸缩合物 2-[(3-amino-3-carboxypropane)amide]butanedioic acid 60079-22-3 C8H12N2O7
长春酸胺 Vincaminsaeure 28152-73-0 C20H24N2O3
长春西汀杂质K (3S,16R,14R)-vincamine 83508-83-2 C21H26N2O3
长春西汀杂质J vincamine 83508-82-1 C21H26N2O3
长春西汀杂质27 Ethyl vincaminate N-oxide 52341-36-3 C22H28N2O4
长春素 Leurosin 23360-92-1 C46H56N4O9
锦葵素-3-O-葡萄糖苷 malvidin 3-O-glucoside 18470-06-9 C23H25O12
锂2-(4-(甲基磺酰基)苯基)乙酸酯 lithium (4-methylsulfonylphenyl)acetate 1421227-96-4 C9H9O4S*Li
铝镁加 Almagate 66827-12-1 CH11AlMg3O12
钙泊三醇一水合物 calcipotriol monohydrate 147657-22-5 C27H40O3*H2O
钆布醇EP杂质A 1,7-bis(carboxymethyl)-4,10-bis(1-hydroxymethyl-2,3-dihydroxypropyl)-1,4,7,10-tetraazacyclododecane 2514736-58-2 C20H40N4O10
醋酸阿比特龙杂质 17-(3-pyridyl)androsta-3,5,16-triene 154229-20-6 C24H29N
醋酸缩宫素 oxytocin acetate 6233-83-6 C2H4O2*C43H66N12O12S2
醋酸甲基泼尼松龙EP杂质H Unii-5TH7YF93MX 1968-76-9 C24H32O4
醋酸夫替瑞林 Fertirelin acetate 66002-66-2 C57H80N16O14
醋丁洛尔杂质F N-(3-Acetyl-4-(2,3-dihydroxypropoxy)phenyl)butanamide 96480-91-0 C15H21NO5
醋丁洛尔杂质A N-(3-Acetyl-4-(oxiran-2-ylmethoxy)phenyl)butanamide 28197-66-2 C15H19NO4
酮洛芬相关物质C 2-(3-Carboxyphenyl)-propionsaeure 68432-95-1 C10H10O4
酮比索洛尔-d5 2-(Methylethoxy)ethyl 4-{2-hydroxy-3-[(methylethyl)amino]propoxy}benzoate 864544-37-6 C18H29NO5
酮替芬 ketotifen 34580-13-7 C19H19NOS
酮康唑杂质7 (2-(2,4-dichlorophenyl)-2-methyl-1,3-dioxolan-4-yl)methanol 172032-21-2 C11H12Cl2O3
酮康唑杂质 Ethanone, 1-[4-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-oxido-1-piperazinyl]-, rel- 254912-65-7 C26H28Cl2N4O5
酞氨青霉素盐酸盐 talampicillin hydrochloride 39878-70-1 C24H23N3O6S*ClH
酒石酸异丙酯 (2R,3R)-2,3-Dihydroxy-4-oxo-4-[(propan-2-yl)oxy]butanoic acid 116601-09-3 C7H12O6
邻苯二甲酰基氨氯地平 phthaloyl amlodipine 88150-62-3 C28H27ClN2O7
邻碘马尿酸钠 133-17-5 C9H8INNaO3
那格列奈相关物质B [(trans-4-isopropyl cyclohexyl)-carbonyl]-D-phenylalanine 105816-05-5 C19H27NO3
那格列奈杂质 D-Phenylalanyl Nateglinide 944746-48-9 C28H36N2O4
那可汀 noscapine 6035-40-1 C22H23NO7
迷人醇 1,8-dihydroxy-3-hydroxymethyl-6-methoxy-anthraquinone 569-05-1 C16H12O6
迪高替尼 delgocitinib 1263774-59-9 C16H18N6O
达西司坦 N,S-diacetyl-L-cysteine 18725-37-6 C7H11NO4S
达泊西汀杂质42 1-naphthyl mesylate 38262-42-9 C11H10O3S
达泊西汀杂质25 1,3-Diphenyl-propan-1-ol 14097-24-6 C15H16O
达泊西汀杂质12 α-ethyl-N,N-dimethylbenzenemethanamine 3330-05-0 C11H17N
达泊西汀杂质 (-)-dapoxetine 119357-36-7 C21H23NO
达沙替尼杂质K 2-(4-(6-((5-((2-chloro-6-methylphenyl)carbamoyl)thiazol-2-yl)amino)-2-methylpyrimidin-4-yl)piperazin-1-yl)ethyl acetate 1245157-85-0 C24H28ClN7O3S
达沙替尼二聚杂质 Dasatinib Dimeric Impurity 910297-61-9 C36H34Cl2N12O2S2
达沙替尼N-氧化物 dasatinib N-oxide 910297-52-8 C22H26ClN7O3S
达比加群酯杂质J BIBR 1155 SE 3-(2-(((4-(((hexyloxy)carbonyl)carbamoyl)phenyl)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propionic acid 1408238-37-8 C32H36N6O6
达格列净杂质54 2,2'-diethoxy-benzil 342043-51-0 C18H18O4
达格列净杂质5 1-{4-chloro-3-[1-(4-ethyloxyphenyl)(methoxy)methyl]phenyl}-1-deoxy-β-D-glucopyranose 1318794-28-3 C22H27ClO7
达格列净杂质23 (2R,3R,4R,5S,6S)-2-(acetoxymethyl)-6-(4-chloro-3-(4-hydroxybenzyl)phenyl)tetrahydro-2H-pyran-3,4,5-triyl triacetate 1079083-63-8 C27H29ClO10
达格列净杂质10 (2S,3R,4S,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-2,3,4,5-tetraol 960404-86-8 C21H25ClO7