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 |
|---|---|---|---|---|
| 咪达那新杂质 | 4-(2-methyl-4,5-dioxoimidazolidin-1-yl)-2,2-diphenylbutanamide | 503598-05-8 | C20H21N3O3 |
|
| 咪达唑仑杂质B | 8-chloro-6-(2-fluorophenyl)-1-methyl-6H-imidazo<1,5-a><1,4>benzodiazepine | 59469-74-8 | C18H13ClFN3 |
|
| 咪达唑仑杂质 | 7-Chloro-1-(3-fluorophenyl)-3-methylidene-2-nitro-4-oxo-2,3-dihydro-1H-1,4lambda~5~-benzodiazepine | 60656-76-0 | C16H11ClFN3O3 |
|
| 咪康唑杂质I | 1-<β-(o-Chlorbenzyloxy)-2',4'-dichlorphenethyl>-imidazol | 47363-37-1 | C18H15Cl3N2O |
|
| 咪唑-2-甲酸 | 1H-imidazole-2-carboxylic acid | 16042-25-4 | C4H4N2O2 |
|
| 咖啡酸甲酯 | methyl 3,4-dihydroxycinnamate | 3843-74-1 | C10H10O4 |
|
| 咖啡因杂质 | methylliberine | 51168-26-4 | C9H12N4O3 |
|
| 咖啡啶 | caffeidine | 20041-90-1 | C7H12N4O |
|
| 呋曲安奈德 | Triamcinolone furetonide | 4989-94-0 | C33H35FO8 |
|
| 呋塞米杂质08 | 2-furfurylamino-5-sulfamoyl-benzoic acid | 4818-85-3 | C12H12N2O5S |
|
| 呋塞米杂质07 | 4-hydroxy-N-furfuryl-5-sulfamoylanthranilic acid | 133989-65-8 | C12H12N2O6S |
|
| 呋塞米杂质 | 2,4-Dichloro-5-sulfobenzoic acid | 41332-59-6 | C7H4Cl2O5S |
|
| 呋喃苯胺酸酰基葡糖苷酸 | Furosemide glucuronide | 72967-59-0 | C18H19ClN2O11S |
|
| 吲哚-3-甲酸乙酯 | indole-3-carboxylic acid ethyl ester | 776-41-0 | C11H11NO2 |
|
| 吡啶并[2,3-d]嘧啶-7(8h)-酮,2,6-二溴-8-环戊基-5-甲基- | 2,6-dibromo-8-cyclopentyl-5-methylpyrido[2,3-d]pyrimidin-7(8H)-one | 1415560-29-0 | C13H13Br2N3O |
|
| 吡咯烷正离子,3-[(环戊基羟基苯乙酰)氧代]-1,1-二甲基-,溴化,[R-(R*,S*)]- | (3RS)-3-[(2SR)-(2-cyclopentyl-2-hydroxy-2-phenylacetyl)oxy]-1, 1-dimethylpyrrolidinium bromide | 129784-11-8 | Br*C19H28NO3 |
|
| 吡咯他尼 | piretanide | 55837-27-9 | C17H18N2O5S |
|
| 吡仑帕奈杂质1 | 3-(1,3,2-Dioxaborinan-2-yl)benzonitrile | 684648-40-6 | C10H10BNO2 |
|
| 吡仑帕奈杂质 | 3-(4-Cyanophenyl)-5-(2-pyridyl)-1-phenyl-1,2-dihydropyridin-2-one | 380918-54-7 | C23H15N3O |
|
| 吡仑帕奈杂质 | 3-(3-cyanophenyl)-5-(2-pyridyl)-1-phenyl-1,2-dihydropyridin-2-one | 380918-53-6 | C23H15N3O |
|
| 吡仑帕奈 | 3-bromo-5-(2-pyridyl)-1,2-dihydropyridin-2-one | 381233-79-0 | C10H7BrN2O |
|
| 向内-N-(9-甲基-9-氮杂双环[3.3.1]壬烷-3基)-1H-吲唑-3-甲酰胺 | endo-N-(9-methyl-9-azabicyclo[3.3.1]non-3-yl)-indazole-3-carboxamide | 107007-95-4 | C17H22N4O |
|
| 向内-N-(9-甲基-9-氮杂双环[3.3.1]壬烷-3基)-1-甲基-1H-吲唑-3-甲酰胺 | 1-Methyl-1H-indazole-3-carboxylic acid (9-aza-bicyclo[3.3.1]non-3-yl)-amide | 160177-67-3 | C17H22N4O |
|
| 吉西他滨T9(ALFA/BETA混合物) | 1-(2-deoxy-2',2'-difluoro-3',5'-di-O-benzoyl-D-ribofuranosyl)-4-aminopyrimidin-2-one | 1155863-81-2 | C23H19F2N3O6 |
|
| 合成左氧氟沙星 | ethyl 3-ethoxy-2-(2,3,4,5-tetrafluorobenzoyl)acrylate | 103995-33-1 | C14H12F4O4 |
|
| 右美沙芬杂质C | (+)-3-Methoxy-17-methylmorphinan-10-one | 57969-05-8 | C18H23NO2 |
|
| 右美沙芬EP杂质D | 14-epi-Dextromethorphan | 1453167-99-1 | C18H25NO |
|
| 叔丁氧羰基-利拉利汀 | 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-[(R)-3-(tert-butoxycarbonylamino)-piperidin-1-yl]-2,6-dioxo-2,3,6,7-tetrahydro-1H-purine | 668273-75-4 | C30H36N8O4 |
|
| 叔丁基-6-溴-2H-吡啶并[3,2-B][1,4]恶嗪-4(3H)-羧酸盐 | tert-butyl 6-bromo-2,3-dihydro-4H-pyrido[3,2-b][1,4]oxazine-4-carboxylate | 959992-64-4 | C12H15BrN2O3 |
|
| 反式-度骨化醇 | 1α-hydroxy-5,6-trans-vitamin D<sub>2</sub> | 74007-20-8 | C28H44O2 |
|
| 反式-4-氧基-2-丁烯酸乙酯 | 4-oxo-but-2-enoic acid ethyl ester | 2960-66-9 | C6H8O3 |
|
| 双（3,5-二叔丁基苯-4-醇）二硫化物 | 4,4'-dithiobis(2,6-di-tert-butylphenol) | 6386-58-9 | C28H42O2S2 |
|
| 双醋瑞因杂质 | monoacetylrhein | 875535-35-6 | C17H10O7 |
|
| 双苄福莫特罗 | N-[5-(2-{benzyl[2-(4-methoxyphenyl)-1-methylethyl]amino}-1-hydroxyethyl)-2-benzyloxyphenyl]formamide | 43229-70-5 | C33H36N2O4 |
|
| 双肼屈嗪杂质 | 1-amino-4-hydrazinophthalazine | 649765-80-0 | C8H9N5 |
|
| 双氯芬酸钠杂质C | 2-(2',6'-dichloroanilino)benzyl alcohol | 27204-57-5 | C13H11Cl2NO |
|
| 双氢麦角汀 甲磺酸盐 | dihydroergocristine methane sulfonate | 24730-10-7 | CH4O3S*C35H41N5O5 |
|
| 双乙酸呋曲安奈德 | triamcinolone diacetate | 67-78-7 | C25H31FO8 |
|
| 双(4-羧基苄基)胺 | bis(4-carboxy-benzyl)amine | 14900-61-9 | C16H15NO4 |
|
| 双(4-甲基哌嗪-1-基)甲酮 | bis(4-methylpiperazin-1-yl)methanone | 4180-30-7 | C11H22N4O |
|
| 去羧基左氧氟沙星 | Decarboxyl ofloxacin, (S)- | 178964-53-9 | C17H20FN3O2 |
|
| 去羧基1-羟基酮咯酸 | (1-hydroxy-2,3-dihydro-1H-pyrrolizin-5-yl)(phenyl)methanone | 154476-25-2 | C14H13NO2 |
|
| 去羟基乙氧基替格雷洛 | AR-C124910XX | 220347-05-7 | C21H24F2N6O3S |
|
| 去硝基奥硝唑 | Ornidazole metabolite M2 | 1565482-62-3 | C7H11ClN2O |
|
| 去甲雄三烯醇酮 | 17alpha-Trenbolone | 80657-17-6 | C18H22O2 |
|
| 去甲肾上腺素杂质 | dopamine β-sulfonate | 24159-36-2 | C8H11NO5S |
|
| 去甲糖胺基万古霉素 | vancomycin pseudoaglycon | 101485-50-1 | C59H62Cl2N8O22 |
|
| 去甲氯丙嗪 | Norchlorpromazine | 1225-64-5 | C16H17ClN2S |
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| 去甲氧基氟伏沙明 | Desmethoxy Fluvoxamine | 1217216-82-4 | C14H19F3N2O |
|
| 去甲新伐地那非 | Norneovardenafil | 358390-39-3 | C18H20N4O4 |
|
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