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 |
|---|---|---|---|---|
| （5-溴-2-氯苯基）（4-羟基苯基）甲酮 | (5-bromo-2-chlorophenyl)(4-hydroxyphenyl)methanone | 1360568-68-8 | C13H8BrClO2 |
|
| （3S，3aR，8aR）-3,8a-二羟基-5-异丙基-3,8-二甲基-2,3,3a，4,5,8a-六氢-1H-天青-6-酮 | Aerugidiol | 116425-35-5 | C15H22O3 |
|
| （2S，3S，5S）-5-（叔丁氧基甲酰氨基）-2-（N-5-噻唑基-甲氧羰基）氨基-1，6-二苯基-3-羟基己烷 | (2S,3S,5S)-5-[N-[(tert-butyloxy)carbonyl]amino]-2-[N-[(5-thiazolyl)methoxycarbonyl]amino]-1,6-diphenyl-3-hydroxyhexane | 162849-95-8 | C28H35N3O5S |
|
| 龙血素D | Loureirin D | 119425-91-1 | C16H16O5 |
|
| 黑介子苷 | sinigrin | 534-69-0 | C10H17NO9S2 |
|
| 黄芩黄酮 | rivularin | 70028-59-0 | C18H16O7 |
|
| 黄芩素 6-O-beta-D-吡喃葡萄糖苷 | baicalein 6-O-β-D-glucopyranoside | 28279-72-3 | C21H20O10 |
|
| 麦角甾醇葡萄糖苷 | ergosterol 3-O-β-D-glucopyranoside | 130155-33-8 | C34H54O6 |
|
| 鲸蜡硬脂醇 | 7-Fluoro-18-hydroxy-2-phenyl-9-oxa-1,15,22-triazatetracyclo[13.7.1.03,8.017,22]tricosa-3(8),4,6,11,17,20-hexaene-16,19-dione | 246159-33-1 | C25H22FN3O4 |
|
| 鲁拉西杂质E | 4,7-Methano-1H-isoindole-1,3(2H)-dione, 2-((2-((4-(1,2-benzisothiazol-3-yl)-1-piperazinyl)methyl)cyclohexyl)methyl)hexahydro-, monohydrochloride, (2(trans),3aalpha,4beta,7beta,7aalpha)-(-)- | 139563-29-4 | C28H37ClN4O2S |
|
| 高活性黄芪甲苷(环黄芪醇葡萄糖苷) | brachyoside B | 86764-12-7 | C36H60O10 |
|
| 高圣草素-7-O-Β-D-葡萄糖苷 | homoeriodictyol 7‐O‐β‐D‐glycoside | 14982-11-7 | C22H24O11 |
|
| 马里甙 | marein | 535-96-6 | C21H22O11 |
|
| 马西替坦杂质 | 5-(4-bromophenyl)-6-(2-((5-bromopyrimidin-2-yl)oxy)-ethoxy)pyrimidin-4-amine | 1433875-21-8 | C16H13Br2N5O2 |
|
| 马西替坦原料药杂质D | ethylaminosulfonic acid [5-(4-bromo-phenyl)-6-[2-(5-bromo-pyrimidin-2-yloxy)-ethoxy]-pyrimidin-4-yl]-amide | 441796-13-0 | C18H18Br2N6O4S |
|
| 马西替坦原料药杂质B | N-[5-(4-bromophenyl)-6-{2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy}-4-pyrimidinyl]-N'-methylsulfuric diamide | 441798-25-0 | C17H16Br2N6O4S |
|
| 马来酸氟吡汀杂质A | 5-(4-fluorobenzylamino)-1,3-dihydro-2H-imidazo[4,5-b]pyridine-2-one | 951624-49-0 | C13H11FN4O |
|
| 马来酸氟吡汀二聚体 | diethyl {6,6'-diamino-2,2'-bis[(4-fluorobenzyl)amino]-3,3'-bipyridine-5,5'-diyl}biscarbamate | 1417916-52-9 | C30H32F2N8O4 |
|
| 马兜铃酸钠 | 10190-99-5 | C17H11NNaO7 |
|
|
| 飞燕草素-3-O-葡萄糖苷 | delphinidin-3-O-glucoside | 50986-17-9 | C21H21O12 |
|
| 顺式-2(2,4-二氯-苯基)-2-溴甲基-4-羟基-甲基-1,3-二氧杂戊环 | (2-(Bromomethyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methanol | 68751-57-5 | C11H11BrCl2O3 |
|
| 非那西丁杂质7 | <i>N</i>-(4-ethoxy-phenyl)-<i>p</i>-phenylenediamine | 60457-49-0 | C14H16N2O |
|
| 非那西丁杂质3 | trans-4-Ethoxy-4'-chlor-azoxybenzol | 24176-84-9 | C14H13ClN2O2 |
|
| 非诺贝特杂质F | (4-chlorophenyl)(4-isopropoxyphenyl)methanone | 154356-96-4 | C16H15ClO2 |
|
| 非诺贝特杂质E | 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropionic acid ethyl ester | 42019-08-9 | C19H19ClO4 |
|
| 非诺贝特杂质D | 2-[4-(4-chlorobenzoyl)phenoxy]-2-methyl-propionic acid, 1-methyl ester | 42019-07-8 | C18H17ClO4 |
|
| 非诺贝特杂质C | Fenofibrate Impurity G | 217636-48-1 | C24H27ClO6 |
|
| 非索非那定甲酯 | fexofenadine methyl ester | 154825-96-4 | C33H41NO4 |
|
| 非索非那定杂质C | 4-(4'-(hydroxy(diphenyl)methyl)piperidin-1-yl)-1-(4-isopropylphenyl)butan-1-ol | 185066-37-9 | C31H39NO2 |
|
| 非索非那定杂质8 | 2-[4-(4-chloro-butyryl)-phenyl]-2-methyl-propionitrile | 169032-17-1 | C14H16ClNO |
|
| 非洛地平杂质C | 4-(2,3-dichloro-phenyl)-2,6-dimethyl-1,4-dihydro-pyridine-3,5-dicarboxylic acid diethyl ester | 79925-38-5 | C19H21Cl2NO4 |
|
| 非布索坦酰基-beta-D-葡糖苷酸 | Febuxostat Acyl Glucuronide | 1351692-92-6 | C22H24N2O9S |
|
| 非布索坦杂质Z19 | 2-[3-formyl-4-(2-methylpropoxy)phenyl]-4-methyl-5-thiazolecarboxylic acid | 144060-62-8 | C16H17NO4S |
|
| 非布索坦杂质E | 2-(4-Isobutoxyphenyl)-4-methylthiazole-5-carboxylic acid | 1206550-99-3 | C15H17NO3S |
|
| 非布索坦杂质66 | 2-(3-cyano-4-isobutoxyphenyl)-N,N,4-trimethylthiazole-5-carboxamide | 1380049-45-5 | C18H21N3O2S |
|
| 非布索坦杂质65 | 2-[3-formyl-4-(2-methylpropoxy)phenyl]-N,N-4-trimethylthiazole-5-carboxamide | 1380049-42-2 | C18H22N2O3S |
|
| 非布索坦杂质64 | 2-(3-formyl-4-isobutyloxy phenyl)-4-methyl-thiazole-5-carboxylic acid isobutyl ester | 1312815-36-3 | C20H25NO4S |
|
| 非布司他杂质37 | 4-(2-Methylpropoxy)-1,3-benzenedicarbothioamide | 1330632-46-6 | C12H16N2OS2 |
|
| 非布司他杂质26 | 2-(3-carboxy-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylic acid | 1239233-87-4 | C16H17NO5S |
|
| 青霉素杂质F氢化物 | potassium salt of 6-pentylpenicillin | 31447-86-6 | C14H21N2O4S*K |
|
| 青霉素杂质C | 6β-[2-(4-hydroxy-phenyl)-acetylamino]-penicillanic acid ; sodium-salt | 5985-13-7 | C16H17N2O5S*Na |
|
| 青霉素G杂质D(EP) | benzylpenicillic acid | 13093-87-3 | C16H18N2O4S |
|
| 青霉噻唑酸V | Phenoxymethyl-penicilloinsaeure | 1049-84-9 | C16H20N2O6S |
|
| 青蒿烯 | artemisitene | 101020-89-7 | C15H20O5 |
|
| 霉酚酸酯杂质1 | ethyl (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1H-isobenzofuran-5-yl)-4-methylhex-4-enoate | 32483-51-5 | C19H24O6 |
|
| 雷贝拉唑砜 N-氧化物 | 2-{[4-(3-methoxypropoxy)-3-methyl-1-oxidopyridin-2-yl]methyl}sulfonyl-1H-benzimidazole | 924663-37-6 | C18H21N3O5S |
|
| 雷贝拉唑砜 | LY 307640 sulfone | 117976-47-3 | C18H21N3O4S |
|
| 雷贝拉唑杂质2 | 1-(1H-Benzo[d]imidazol-2-yl)-4-(3-methoxypropoxy)-3-methylpyridin-1-ium-2-carboxylate | 1807988-36-8 | C18H19N3O4 |
|
| 雷贝拉唑 N-氧化物 | 2-[[(RS)-(1H-benzimidazol-2-yl)sulfinyl]methyl]-4-(3-methoxypropoxy)-3-methylpyridine 1-oxide | 924663-38-7 | C18H21N3O4S |
|
| 雷诺嗪杂质 | Desmethoxy Ranolazine | 755711-09-2 | C23H31N3O3 |
|
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