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 |
|---|---|---|---|---|
| 普罗布考相关物质CUSP标准品 | Unii-766TS5X5KV | 1391054-68-4 | C31H48O2S2 |
|
| 普瑞巴林杂质D | epiCDT | 890044-38-9 | C28H26F6N4S |
|
| 普瑞巴林杂质76 | 5-methyl-3-(nitromethyl)hexanoic acid | 181289-21-4 | C8H15NO4 |
|
| 普瑞巴林杂质50 | (-)-(S)-3-(benzyloxycarbonylamino-methyl)-5-methyl-hexanoic acid | 949890-75-9 | C16H23NO4 |
|
| 普瑞巴林杂质48 | isopropyl (S)-3-aminomethyl-5-methylhexanoate | 1239856-83-7 | C11H23NO2 |
|
| 普瑞巴林杂质44 | dimethyl 3-isobutyl glutarate | 145328-03-6 | C11H20O4 |
|
| 普瑞巴林杂质19 | (R)-isopropyl 2-hydroxy-2-phenylacetate | 89015-27-0 | C11H14O3 |
|
| 普瑞巴林杂质 | 2-i-butyl-1,3-diaminopropane | 159029-27-3 | C7H18N2 |
|
| 普拉洛芬杂质K | 7-(1-carboxyethyl)-5H-benzopyran[2,3-b]-1-pyridine nitrogen oxide | 52549-44-7 | C15H13NO4 |
|
| 普拉洛芬杂质32 | 5<i>H</i>-chromeno[2,3-<i>b</i>]pyridin-7-yl-acetic acid | 52549-07-2 | C14H11NO3 |
|
| 普拉洛芬杂质03 | 2-(5H-[1]benzopyrano[2,3-b]pyridin-7-yl)acrylic acid | 52549-22-1 | C15H11NO3 |
|
| 普拉格雷杂质III | 5-(2-cyclopropyl-1-(4-fluorophenyl)-2-oxoethyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate | 1391194-50-5 | C20H20FNO3S |
|
| 普拉格雷杂质7(3-F-PM-A) | 2-bromo-1-cyclopropyl-2-(3-fluorophenyl)ethanone | 1359829-72-3 | C11H10BrFO |
|
| 普拉格雷杂质1 | 5-(2-cyclopropyl-2-oxo-1-phenylethyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate | 1391194-45-8 | C20H21NO3S |
|
| 普拉格雷杂质 | 2-acetoxy-4,5,6,7-tetrahydrothieno[3,2-c]pyridine | 1151904-85-6 | C9H11NO2S |
|
| 普拉曲沙杂质8 | 5-ethyl 1-methyl (2S)-2-aminopentanedioate | 112408-16-9 | C8H15NO4 |
|
| 普拉各雷Alpha-羟基杂质 | 2-hydroxy-1-cyclopropyl-2-(2-fluorophenyl)ethanone | 1100905-45-0 | C11H11FO2 |
|
| 普拉克索杂质16 | NE-2-152-2 | 1373869-91-0 | C11H17N3O2 |
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| 普拉克索杂质08 | (e)-2-(5-(cyanoimino)-1-propylpyrrolidin-2-yl)acetic acid | 1373869-89-6 | C10H15N3O2 |
|
| 普拉克索7-氧代杂质 | 2-amino-6-(propylamino)-5,6-dihydrobenzothiazol-7(4H)-one | 1286047-33-3 | C10H15N3OS |
|
| 普乐沙福杂质19 | 1-(4,8-bis-(2,2,2-trifluoroacetyl)-11-{4-[4,8,11-tris-(2,2,2-trifluoroacetyl)-1,4,8,11-tetraazacyclotetradec-1-ylmethyl]-benzyl}-1,4,8,11-tetraazacyclotetradec-1-yl)-2,2,2-trifluoroethanone | 406939-93-3 | C40H48F18N8O6 |
|
| 普乐沙福杂质10 | 1,11-N,N'-bis(p-toluenesulphonyl)-1,4,8,11-tetraazacyclotetradecane | 117152-73-5 | C24H36N4O4S2 |
|
| 普乐沙福杂质06 | 4-(1,4,8,11-Tetrazacyclotetradec-1-ylmethyl)benzaldehyde | 1254176-45-8 | C18H30N4O |
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| 普乐沙福杂质 | N,N',N'',N'''-tetratosyl-1,10-diamino-4,7-diazadecane | 74676-47-4 | C36H46N4O8S4 |
|
| 普乐沙福中间体-1 | 1,4,8-tritosyl-1,4,8,11-tetraazacyclotetradecane | 104395-69-9 | C31H42N4O6S3 |
|
| 易瑞沙氮氧化物 | 4-(3-((4-((3-chloro-4-fluorophenyl)amino)-7-methoxyquinazolin-6-yl)oxy)propyl)morpholine 4-oxide | 847949-51-3 | C22H24ClFN4O4 |
|
| 新霉胺 | neomycin A | 3947-65-7 | C12H26N4O6 |
|
| 文诺普兰 | 5-(2-fluorophenyl)-1H-pyrrole-3-methanol | 881674-58-4 | C11H10FNO |
|
| 文拉法辛杂质4 | 1,3-bis(4-methoxyphenyl)acetone | 29903-09-1 | C17H18O3 |
|
| 文拉法辛杂质13 | 5-(4-methoxyphenyl)-3-aza-1-oxaspiro[5,5]undecane | 727728-51-0 | C16H23NO2 |
|
| 文拉法辛杂质 | (±)-1-{2-[(4-methoxyphenethyl)(methyl)amino]-1-(4-methoxyphenyl)ethyl}cyclohexanol | 1346601-14-6 | C25H35NO3 |
|
| 拉贝洛尔杂质D(EP) | 5-(2-amino-1-hydroxyethyl)-2-hydroxybenzamide hydrochloride | 32780-65-7 | C9H12N2O3*ClH |
|
| 拉贝洛尔杂质A | Labetalol Impurity A | 1391051-99-2 | C19H23NO4 |
|
| 拉贝洛尔-1-羧酸甲酯 | Labetalol-1-carboxylic Acid Methyl Ester | 802620-01-5 | C20H25NO4 |
|
| 拉莫昔克杂质1 | decarboxy-moxalactam | 75007-70-4 | C19H20N6O7S |
|
| 拉米夫定杂质7 | 1,3-Oxathiolane-2-carboxylic acid, 5-hydroxy-, 5-methyl-2-(1-methylethyl)cyclohexyl ester, [1R-[1alpha(2S*,5S*),2beta,5alpha]]- | 147126-63-4 | C14H24O4S |
|
| 拉米夫定杂质26 | (1R,2S,5R)-2-isopropyl-5-methylcyclohexyl methanesulfonate | 61548-81-0 | C11H22O3S |
|
| 拉米夫定S-氧化物（异构体混合物） | Lamivudine sulfoxide | 1235712-40-9 | C8H11N3O4S |
|
| 拉米夫定 | (+/-)-trans-N-<2-(hydroxymethyl)-1,3-oxathiolan-5-yl>cytosine | 136846-20-3 | C8H11N3O3S |
|
| 拉沙吉林杂质9 | N-allyl-2,3-dihydro-1H-inden-1-amine | 91639-43-9 | C12H15N |
|
| 拉氧头孢杂质 | (6R,7R)-benzhydryl 7-(4-methylbenzamide)-3-(chloromethyl)-7-methoxy-8-oxo-5-oxa-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylate | 68314-38-5 | C30H27ClN2O6 |
|
| 拉帕替尼杂质10 | N-(3-chloro-4-((3-fluorobenzyl)oxy)phenyl)-6-(5-carboxy-2-furyl)-4-quinazolinamine | 1152131-73-1 | C26H17ClFN3O4 |
|
| 拉帕替尼杂质1 | Lapatinib metabolite M1 | 1268997-70-1 | C22H21ClN4O4S |
|
| 拉夫米定EP杂质H | Lamivudine sulfoxide, (R)- | 160552-54-5 | C8H11N3O4S |
|
| 拉坦前列腺素 | (3aR,4R,5R,6aS)-5-hydroxy-4-((S,E)-3-hydroxy-5-phenylpent-1-en-1-yl)hexahydro-2H-cyclopenta[b]furan-2-one | 41639-74-1 | C18H22O4 |
|
| 拉坦前列素杂质7 | Tafluprost Impurity 7 | 733036-94-7 | C25H35FO5 |
|
| 拉坦前列素杂质 | latanoprost iMpurity | 733036-95-8 | C25H35FO5 |
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| 拉坦前列素中间体 | (3aR,4R,5R,6aS)-4-((S,E)-3-Hydroxy-5-phenylpent-1-enyl)hexa hydro-2H-cyclopenta[b]furan-2,5-diol | 856240-62-5 | C18H24O4 |
|
| 托莫西汀杂质DEP标准品 | N-methyl-3-phenyl-3-(m-tolyloxy)propan-1-amine | 873310-29-3 | C17H21NO |
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| 托法替尼系列杂质 | 3-((3R,4R)-4-methyl-3-(methylamino)piperidin-1-yl)-3-oxopropanenitrile hydrochloride | 1206824-85-2 | C10H17N3O*ClH |
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