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 |