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 |
|---|---|---|---|---|
| 苯扎隆 | benzarone | 1477-19-6 | C17H14O3 |
|
| 苯扎贝特杂质1 | N,O-Bis-(4-chlorobenzoyl)tyramine | 41859-56-7 | C22H17Cl2NO3 |
|
| 苯基吡啶-2-羧酸酯 | phenyl picolinate | 26838-86-8 | C12H9NO2 |
|
| 苯基(4-(6-氨甲酰-7-甲氧基-4-基)氧基)-2-氯苯基氨基甲酸酯 | phenyl (4-((6-carbamoyl-7-methoxyquinolin-4-yl)oxy)-2-chlorophenyl)carbamate | 417722-95-3 | C24H18ClN3O5 |
|
| 苯唑西林杂质3 | 6β-[3-(4-chloro-phenyl)-5-methyl-isoxazole-4-carbonylamino]-penicillanic acid | 21106-64-9 | C19H18ClN3O5S |
|
| 苯唑西林杂质1 | 3,3-dimethyl-6-{[(5-methyl-3-phenylisoxazol-4-yl)carbonyl]amino}-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid 4-oxide | 36231-30-8 | C19H19N3O6S |
|
| 苯哌利多 | benperidol | 2062-84-2 | C22H24FN3O2 |
|
| 苜蓿素-7-O-葡萄糖苷 | tricin-7-β-D-glucopyranoside | 32769-01-0 | C23H24O12 |
|
| 苏戈莫德杂质2 | 2-amino-2-(4-heptylphenethyl)propane-1,3-diol | 745767-97-9 | C18H31NO2 |
|
| 苏尼替尼N-1 | N-[2-(ethylamino)ethyl]-5-formyl-2,4-dimethyl-1H-pyrrole-3-carboxamide | 356068-98-9 | C12H19N3O2 |
|
| 苄星青霉素 | Penicillin G Benzathine | 41372-02-5 | C48H64N6O12S2 |
|
| 苄基青霉酸 | benzylpenicilloic acid | 13057-98-2 | C16H20N2O5S |
|
| 芬戈莫德杂质D | 2-amino-2-(4-decylphenethyl)propane-1,3-diol | 780729-32-0 | C21H37NO2 |
|
| 芬戈莫德杂质 | 2-amino-2-(2-{4-octyl-2-[2-(4-octylphenyl)ethyl]phenyl}ethyl)propane-1,3-diol | 851039-25-3 | C35H57NO2 |
|
| 芬戈莫德杂质 | 2-amino-2-[2-(4-nonylphenyl)ethyl]propane-1,3-diol | 746594-44-5 | C20H35NO2 |
|
| 芬戈莫德己基杂质 | 2-amino-2-(4-hexylphenethyl)propane-1,3-diol | 1201794-93-5 | C17H29NO2 |
|
| 芜地溴铵杂质8 | 1-Benzyl-4-(hydroxydiphenylmethyl)quinuclidin-1-ium bromide | 869113-10-0 | C27H30BrNO |
|
| 芜地溴铵杂质4 | 4-[Hydroxy(diphenyl)methyl]-1-(2-hydroxyethyl)-1-azoniabicyclo[2.2.2]octane Bromide | 869112-31-2 | C22H28BrNO2 |
|
| 艾洛骨化醇 | Elocalcitol | 199798-84-0 | C29H43FO2 |
|
| 艾沙康唑杂质24 | Isavuconazole Impurity 24 | 1176988-44-5 | C22H17F2N5OS |
|
| 艾曲波帕杂质14 | 4'-hydroxy-3'-nitro-3-biphenylcarboxylic acid | 1097777-60-0 | C13H9NO5 |
|
| 艾曲波帕杂质1 | Eltrombopag Amide | 1246929-02-1 | C25H23N5O3 |
|
| 艾地骨化醇中间体N-1 | (5Z,7E)-(1R,2R,3R)-1,3-bis(tert-butyldimethylsilyloxy)-2-(3-tert-butyldimethylsilyloxypropoxy)-25-triethylsilyloxy-9,10-secocholesta-5,7,10(19)-triene | 933779-95-4 | C54H106O5Si4 |
|
| 艾地苯醌杂质HMD-2 | 2-hydroxy-6-(10-hydroxydecyl)-3-methoxy-5-methyl-1,4-benzoquinone | 88543-33-3 | C18H28O5 |
|
| 艾司西酞普兰杂质 | citalopram propanoic acid | 91283-87-3 | C18H14FNO3 |
|
| 艾司西酞普兰杂质 | 1-oxo-1,3-dihydroisobenzofuran-5-carboxamide | 85118-25-8 | C9H7NO3 |
|
| 艾司洛尔酸钠 | 3-<4-<2-hydroxy-3-(isopropylamino)propoxy>phenyl>propionic acid hydrochloride | 83356-60-9 | C15H23NO4*ClH |
|
| 艾司洛尔酸 | 3-<4-<2-hydroxy-3-(isopropylamino)propoxy>phenyl>propionic acid | 81148-15-4 | C15H23NO4 |
|
| 艾司洛尔二聚体 | Esmolol dimer | 98903-89-0 | C31H46N2O7 |
|
| 艾乐替尼代谢杂质 | 5H-Benzo(b)carbazole-3-carbonitrile, 9-ethyl-6,11-dihydro-8-(4-((2-hydroxyethyl)amino)-1-piperidinyl)-6,6-dimethyl-11-oxo- | 1256585-04-2 | C28H32N4O2 |
|
| 色甘酸钠杂质 | 1-(2-acetyl-3-hydroxyphenoxy)-2,3-epoxypropane | 16130-28-2 | C11H12O4 |
|
| 色甘酸二乙酯 | 5,5’-[(2-hydroxy-1,3-propanediyl)bis(oxy)]bis-4-oxo-4H-1-benzopyran-2-carboxylic acid diethyl ester | 16150-45-1 | C27H24O11 |
|
| 舒马曲普坦中间体 | 3-(2-aminoethyl)-1H-indole-5-yl-N-methyl methane sulphonamide | 88919-22-6 | C12H17N3O2S |
|
| 舒必利氮氧化物 | Benzamide, 5-(aminosulfonyl)-N-((1-ethyl-1-oxido-2-pyrrolidinyl)methyl)-2-methoxy- | 2214214-03-4 | C15H23N3O5S |
|
| 舒巴坦杂质8 | (2S,6S)-6-bromo-3,3-dimethyl-4,4,7-trioxo-4λ6-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid | 75527-87-6 | C8H10BrNO5S |
|
| 舒巴坦杂质8 | (2S,5R,6S)-6β-bromo-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid,S,S-dioxide | 75527-88-7 | C8H10BrNO5S |
|
| 舒巴坦杂质18 | benzhydryl 6α-bromopenicillanate | 74189-25-6 | C21H20BrNO3S |
|
| 舒尼替尼甲酰胺杂质 | (Z)-5-((5-fluoro-2-oxoindolin-3-ylidene)Methyl)-2,4-diMethyl-1H-pyrrole-3-carboxaMide | 1186651-51-3 | C16H14FN3O2 |
|
| 舒尼替尼N-氧化物 | Sunitinib N-oxide | 356068-99-0 | C22H27FN4O3 |
|
| 脱羧氯雷他定杂质B | 13-Bromo-2-piperidin-4-ylidene-4-azatricyclo[9.4.0.03,8]pentadeca-1(11),3(8),4,6,12,14-hexaene | 117796-50-6 | C19H19BrN2 |
|
| 脱羧氧氟沙星 | ofloxacin | 123155-82-8 | C17H20FN3O2 |
|
| 脱羧恩氟沙星 | 7-(4-ethylpiperazin-1-yl)-1-cyclopropyl-6-fluoroquinolin-4-one | 131775-99-0 | C18H22FN3O |
|
| 脱羟基溴塞来考昔 | celecoxib | 170570-75-9 | C17H13BrF3N3O2S |
|
| 脱氯利伐沙班 | N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene-2-carboxamide | 1415566-28-7 | C19H19N3O5S |
|
| 脱氧索他洛尔 | Deoxysotalol | 16974-42-8 | C12H20N2O2S |
|
| 脱氧弗斯特罗定 | 2-{(1S)-3-[Di(propan-2-yl)amino]-1-phenylpropyl}-4-methylphenyl 2-methylpropanoate | 895137-81-2 | C26H37NO2 |
|
| 脱氧异丁基-正丁基硼替佐米 | Desisobutyl-n-butyl Bortezomib | 1104011-35-9 | C19H25BN4O4 |
|
| 脱氢非洛地平 | Dehydrofelodipine | 96382-71-7 | C18H17Cl2NO4 |
|
| 脱氢阿立哌唑盐酸盐 | 7-(4-(4-(2,3-dichlorophenyl)piperazin-1-yl)butoxy)quinolin-2-one dihydrochloride | 1008531-60-9 | C23H25Cl2N3O2*2ClH |
|
| 脱氢贝尼地平 | Dehydro Benidipine | 118935-44-7 | C28H28N3O6- |
|
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