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 |
|---|---|---|---|---|
| 厄洛替尼杂质 | 4-((6,7-Bis(2-methoxyethoxy)quinazolin-4-yl)amino)-2-ethynyl-phenol | 882420-22-6 | C22H23N3O5 |
|
| 厄他培南杂质1(开环) | Ertapenem Ring Open Impurity | 357154-27-9 | C22H27N3O8S |
|
| 厄他培南杂质 | L-Pro-Aba | 724700-26-9 | C12H14N2O3 |
|
| 厄他培南杂质 | 3-{[(2S,4S)-1-(Diisopropoxy-phosphoryl)-4-mercapto-pyrrolidine-2-carbonyl]-amino}-benzoic acid | 220031-86-7 | C18H27N2O6PS |
|
| 厄他培南二聚体D型杂质 | Ertapenem Dimer Form D Impurity | 1199797-41-5 | C44H50N6O14S2 |
|
| 厄他培南二聚体 | Ertapenem Dimer Impurity | 402955-37-7 | C44H48N6O13S2 |
|
| 厄他培南USP杂质D/(R)-羟脯氨酸氨基苯甲酸 | 3-((2S,4R)-4-Hydroxypyrrolidine-2-carboxamido)benzoic acid | 770703-11-2 | C12H14N2O4 |
|
| 厄他培南USP杂质B/(S)-羟脯氨酸氨基苯甲酸 | Benzoic acid, 3-[[[(2S,4S)-4-hydroxy-2-pyrrolidinyl]carbonyl]amino]- | 266337-30-8 | C12H14N2O4 |
|
| 卢帕他定杂质C | Rupatadine Impurity C | 1224515-72-3 | C45H43Cl2N5 |
|
| 卢帕他定杂质B | Rupatadine Impurity B | 156523-04-5 | C26H24ClN3O |
|
| 卢帕他定杂质A | Rupatadine fumarate impurity A [EP] | 1354055-68-7 | C30H31ClN3O4+ |
|
| 卢帕他定杂质 | 8-CHLORO-11-(4-PIPERIDINYL)-11H-BENZO[5,6]CYCLOHEPTA(1,2-b)PYRIDINE | 169253-15-0 | C19H19ClN2 |
|
| 卡麦角林 | cabergoline | 81409-90-7 | C26H37N5O2 |
|
| 卡维地洛杂质DH | 4-(oxiran-2-ylmethoxy)-9-(oxiran-2-ylmethyl)-9H-carbazole | 1198090-71-9 | C18H17NO3 |
|
| 卡维地洛杂质COH | 3-(oxiran-2-ylmethoxy)-9H-carbazole | 51997-50-3 | C15H13NO2 |
|
| 卡维地洛杂质9 | 3,3'-(((1,2-Phenylenebis(oxy))bis(ethane-2,1-diyl))bis(azanediyl))bis(1-((9H-carbazol-4-yl)oxy)propan-2-ol) | 1346602-98-9 | C40H42N4O6 |
|
| 卡维地洛杂质3 | 1-(9H-carbazol-5-yloxy)-3-chloropropan-2-ol | 1187921-93-2 | C15H14ClNO2 |
|
| 卡络磺钠杂质6 | 1-methyl-1H-indol-6-ol | 130570-60-4 | C9H9NO |
|
| 卡波西坦杂质8 | (2R,4R)-S-carboxymethylcysteine sulfoxide | 61475-35-2 | C5H9NO5S |
|
| 卡比多巴杂质J | 2-Bromo (S)-Carbidopa | 43197-33-7 | C10H13BrN2O4 |
|
| 卡比多巴杂质E | methyl (S)-3-(3,4-dihydroxyphenyl)-2-hydrazino-2-methylpropanoate | 52514-63-3 | C11H16N2O4 |
|
| 卡格列净杂质14 | D-Glucitol, 1,5-anhydro-1-C-[3-[[5-(3-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-, (1S)- | 842133-17-9 | C24H25FO5S |
|
| 卡格列净杂质01 | defluoro-canagliflozin | 842133-16-8 | C24H26O5S |
|
| 卡托普利杂质H | (2S)-1-((2S)-3-(((2R)-3-(Acetylsulfanyl)-2-methylpropanoyl)sulfanyl)-2-methylpropanoyl)pyrrolidine-2-carboxylic acid | 205521-07-9 | C15H23NO5S2 |
|
| 卡托普利杂质8 | captopril | 112243-88-6 | C9H15NO3S |
|
| 卡托普利杂质 | (2R)-1-((2S)-3-mercapto-2-methylpropanoyl)pyrrolidine-2-carboxylic acid | 119238-52-7 | C9H15NO3S |
|
| 卡托普利二硫化物 | Captopril disulfide | 64806-05-9 | C18H28N2O6S2 |
|
| 卡巴拉汀杂质12 | 2-[1-(dimethylamino)ethyl]phenol | 26050-44-2 | C10H15NO |
|
| 卡巴地那非 | Carbodenafil | 944241-52-5 | C24H32N6O3 |
|
| 卡巴他赛杂质15 | (2*,4R,5S)-N-tert-butoxycarbonyl-2-(4'-methoxy)phenyl-4-phenyl-1,3-oxazolidine-5-formic acid | 859498-34-3 | C22H25NO6 |
|
| 卡培他滨杂质 | 4-amino-1-(β-<i>D</i>-5-deoxy-arabinofuranosyl)-5-fluoro-1<i>H</i>-pyrimidin-2-one | 71609-08-0 | C9H12FN3O4 |
|
| 卡培他滨USP杂质 | 5'-Deoxy-3'-O-(5-deoxy-alpha-D-ribofuranosyl)-5-fluoro-N-((pentyloxy)carbonyl)cytidine | 1262133-68-5 | C20H30FN3O9 |
|
| 卡培他滨USP杂质 | [1-[5-deoxy-3-O-(5-deoxy-β-d-ribofuranosyl)-β-d-ribofuranosyl]-5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl]-carbamic acid pentyl ester | 1262133-64-1 | C20H30FN3O9 |
|
| 卡培他滨USP杂质 | 5'-Deoxy-2'-O-(5-deoxy-beta-D-ribofuranosyl)-5-fluoro-N-((pentyloxy)carbonyl)cytidine | 1262133-66-3 | C20H30FN3O9 |
|
| 卡培他滨-d11 | Capecitabine-d11 | 1132662-08-8 | C15H22FN3O6 |
|
| 卡博替尼杂质HF | 5-(((3,4-dimethoxyphenyl)amino)methylene)-2,2-dimethyl-1,3-dioxane-4,6-dione | 213699-53-7 | C15H17NO6 |
|
| 卡博替尼杂质HF | diethyl 2-(2-bromoethyl)malonate | 18721-64-7 | C9H15BrO4 |
|
| 卡博替尼杂质DYH | cabozantinib-N-oxide | 1621681-63-7 | C28H24FN3O6 |
|
| 卡博替尼杂质65 | ortho-hydroxycabozantinib | 1628530-38-0 | C28H24FN3O6 |
|
| 卡博替尼杂质51 | Cyclopropan-4-fluor-carboxanilid | 2354-89-4 | C10H10FNO |
|
| 卡博替尼杂质50 | 6,7-Dimethoxy-4-(3-nitro-phenoxy)-quinoline | 202917-05-3 | C17H14N2O5 |
|
| 卡博替尼杂质49 | 6,7-dimethoxy-4-(2-nitrophenoxy)quinoline | 190728-26-8 | C17H14N2O5 |
|
| 卡博替尼杂质47 | 1-((4-chlorophenyl)carbamoyl)cyclopropanecarboxylic acid | 113136-79-1 | C11H10ClNO3 |
|
| 卡博替尼杂质46 | 1-(3-fluorophenylcarbamoyl)cyclopropanecarboxylic acid | 1247859-37-5 | C11H10FNO3 |
|
| 卡博替尼杂质4 | carbonic acid 4-aminophenyl ester tert-butyl ester | 95932-39-1 | C11H15NO3 |
|
| 卡博替尼杂质02 | N-{4-[6,7-dimethoxyquinolin-4-yl-oxy]phenyl}-N'-phenylcyclopropanedicarboxamide | 849221-94-9 | C28H25N3O5 |
|
| 博舒替尼杂质2(N-去甲基博舒替尼) | 4-((2,4-dichloro-5-methoxyphenyl)amino)-6-methoxy-7-(3-(piperazin-1-yl)propoxy)quinoline-3-carbonitrile | 380843-81-2 | C25H27Cl2N5O3 |
|
| 博舒替尼杂质17 | 3-allyloxy-4-methoxynitrobenzene | 142072-71-7 | C10H11NO4 |
|
| 博沙坦杂质D | 4-(t-butyl)-N-(6-hydroxy-5-(2-methoxyphenoxy)-[2,2'-bipyrimidin]-4-yl)benzenesulfonamide | 174227-14-6 | C25H25N5O5S |
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| 博尔扎诺杂质 | (Z)-(R)-4-amino-5-biphenyl-4-yl-2-methyl-pent-2-enoic acid hydrochloride | 1361408-17-4 | C18H19NO2*ClH |
|
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