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 |
|---|---|---|---|---|
| 单-POC替诺福韦6-异丙基氨基甲酸酯 | [(2R)-1-[6-(Propan-2-yloxycarbonylamino)purin-9-yl]propan-2-yl]oxymethyl-(propan-2-yloxycarbonyloxymethoxy)phosphinic acid | 1244022-56-7 | C18H28N5O9P |
|
| 华法林杂质1 | 1-Phenyl-5-methyl-1,4-hexadien-3-on | 55901-61-6 | C13H14O |
|
| 匹多莫德杂质E | (S)-3-<(S)-(5-oxo-2-pyrrolidinyl)carbonyl>-thiazolidine-4-carboxylic acid | 162148-16-5 | C9H12N2O4S |
|
| 匹多莫德杂质D | (S)-3-<(R)-(5-oxo-2-pyrrolidinyl)carbonyl>-thiazolidine-4-carboxylic acid | 162148-15-4 | C9H12N2O4S |
|
| 匹多莫德 杂质 | (S,S)-1,7-diazatricyclo[7.3.0.0<sup>7,11</sup>]dodecane-2,6,8,12-tetrone | 14842-41-2 | C10H10N2O4 |
|
| 匹伐他汀甲酯 | methyl (3R,5S,6E)-7-{2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl}-3,5-dihydroxyhept-6-enoate | 849811-78-5 | C26H26FNO4 |
|
| 匹伐他汀杂质78 | 2-cyclopropyl-4-(4-fluorophenyl)-3-methylquinoline | 1356998-79-2 | C19H16FN |
|
| 匹伐他汀杂质76 | cis-(4R,6S)-2,2-dimethyl-6-formyl-1,3-dioxane-4-acetic acid | 123185-91-1 | C9H14O5 |
|
| 匹伐他汀杂质34 | (6S)-6-{(E)-2-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]vinyl}-5,6-dihydro-2H-pyran-2-one | 148516-15-8 | C25H20FNO2 |
|
| 加替环合酯C | ethyl 1-cyclopropyl-6,7-difluoro-1,4-dihydro-8-ethoxy-4-oxo-3-quinolinecarboxylate | 172602-83-4 | C17H17F2NO4 |
|
| 加替沙星盐酸盐 | gatifloxacin hydrochloride | 121577-32-0 | C19H22FN3O4*ClH |
|
| 加巴喷丁相关化合物D | (1-(3-Oxo-2-aza-spiro(4.5)dec-2-ylmethyl)-cyclohexyl)-acetic acid | 1076198-17-8 | C18H29NO3 |
|
| 加巴喷丁杂质E | 1-carboxycyclohexylacetic acid | 67950-95-2 | C9H14O4 |
|
| 加奈索酮 | ganaxolone | 38398-32-2 | C22H36O2 |
|
| 前列腺素Bx | PGB1 | 13345-51-2 | C20H32O4 |
|
| 前列腺素A(1) | (+/-)-Prostaglandin-A(1) | 13641-87-7 | C20H32O4 |
|
| 前列腺素 A1 | prostaglandin A1 | 14152-28-4 | C20H32O4 |
|
| 刺五加提取物 | (+)-syringaresinol O-β-D-glucopyranoside | 137038-13-2 | C28H36O13 |
|
| 别嘌醇相关物质E | 3-formylamino-1<i>H</i>-pyrazole-4-carboxylic acid ethyl ester | 31055-19-3 | C7H9N3O3 |
|
| 利鲁唑杂质7 | 2-amino-4-bromo-6-trifluoromethoxy-benzothiazole | 144631-82-3 | C8H4BrF3N2OS |
|
| 利福霉素B | Rifamycin B | 13929-35-6 | C39H49NO14 |
|
| 利福昔明杂质B | (2S,20S,21S,22R,23R,24R,25S,26R,27S)-6,21,23-trihydroxy-27-methoxy-2,4,16,20,22,24,26-heptamethyl-11-methylene-1,5,15-trioxo-1,2,5,11-tetrahydro-2,7-(epoxypentadeca[1,11,13]trienoimino)furo[2'',3'':7',8']naphtho[1',2':4,5]imidazo[1,2-a]pyridin-25-yl acetate | 1351775-04-6 | C43H49N3O11 |
|
| 利格列汀杂质26 | 8-Bromo-3-methyl-1,7-bis((4-methylquinazolin-2-yl)methyl)-1H-purine-2,6(3H,7H)-dione | 2138392-83-1 | C26H21BrN8O2 |
|
| 利托那韦杂质C | 1,3-thiazol-5-ylmethyl (1S,2S,4S)-4-(acetylamino)-1-benzyl-2-hydroxy-5-phenylpentylcarbamate | 1010808-43-1 | C25H29N3O4S |
|
| 利托那韦EP杂质T | (2S,3S,5S)-2,5-bis-[N-[N-[[N-methyl-N-[(2-isopropyl-4-thiazolyl)methyl]amino]carbonyl]valinyl]amino]-1,6-diphenyl-3-hydroxyhexane | 869368-48-9 | C46H66N8O5S2 |
|
| 利托那韦EP杂质O | Ritonavir (3R)-hydroxy epimer | 1414933-81-5 | C37H48N6O5S2 |
|
| 利托那韦EP杂质I | 2-Desisopropyl-2-ethyl Ritonavir | 165315-26-4 | C36H46N6O5S2 |
|
| 利托那韦EP杂质B | Des((2-isopropylthiazol-4-yl)methyl-methyl-carbamoyl)ritonavir | 765875-58-9 | C28H36N4O4S |
|
| 利托那韦EP杂质23 | Thiazol-5-ylmethyl (1S,2S,4S)-1-benzyl-2-hydroxy-4-(((2-methylpropoxy)carbonyl)amino)-5-phenylpentyl)carbamate | 1010809-39-8 | C28H35N3O5S |
|
| 利扎曲普坦EP杂质A | 3-[[3-[2-(N,N-dimethylamino)ethyl]-2-[[3-[2-(N,N-dimethylamino)ethyl]-1H-indol-5-yl]methyl]-1H-indol-5-yl]methyl]-1H-1,2,4-triazole | 887001-08-3 | C28H35N7 |
|
| 利巴韦林杂质G | 1-β-D-ribofuranosyl-1H-1,2,4-triazole-5-carboxamide | 39030-43-8 | C8H12N4O5 |
|
| 利巴韦林杂质E | ribavirin benzoate | 58151-90-9 | C15H16N4O6 |
|
| 利巴韦林杂质55 | 1,2,3-tri-O-acetyl-a-D-ribofuranose | 119240-35-6 | C11H16O8 |
|
| 利巴韦林EP杂质F | 5'-O-acetylribavirin | 58151-87-4 | C10H14N4O6 |
|
| 利奥西呱杂质27 | methyl {4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl]pyrimidin-5-yl}ethylcarbamate | 1361570-27-5 | C21H21FN8O2 |
|
| 利奥西呱杂质20 | 1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-carboxylic acid | 956011-26-0 | C14H10FN3O2 |
|
| 利奥西呱杂质13 | 6-amino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl]-7,9-dihydro-8H-purin-8-one | 1361569-10-9 | C18H13FN8O |
|
| 利奈孕醇 | lynestrenol | 52-76-6 | C20H28O |
|
| 利奈唑胺碱 | (S)-N-[[3-[3-fluoro-4-[4-morpholinyl]phenyl]-2-oxo-5-oxazolidinyl]methyl]amine | 168828-90-8 | C14H18FN3O3 |
|
| 利奈唑胺杂质3 | Linezolid N-Oxide | 189038-36-6 | C16H20FN3O5 |
|
| 利多卡因杂质33 | 2,2-dichloro-N-(2,3-dimethylphenyl)acetamide | 18823-63-7 | C10H11Cl2NO |
|
| 利多卡因杂质2 | 1,4-bis-(2,6-dimethyl-phenyl)-piperazine-2,5-dione | 70336-49-1 | C20H22N2O2 |
|
| 利多卡因杂质 | N-(2,6-dimethylphenyl)-2-(methylamino)acetamide hydrochloride | 35891-84-0 | C11H17ClN2O |
|
| 利多卡因FP杂质K | α-(N-Methyl-ethylamino)-2,6-dimethyl-acetanilid | 74634-66-5 | C13H20N2O |
|
| 利多卡因EP杂质I | 2-(Diethylamino)-N-(2,4-dimethylphenyl)acetamide Hydrochloride | 17289-54-2 | C14H23ClN2O |
|
| 利多卡因 N-氧化物 | lidocaine N-oxide | 2903-45-9 | C14H22N2O2 |
|
| 利伐沙班杂质J | 2-{2-[1-(5-chlorothiophen-2-yl)-N-{4-[(5S)-5-{[(5-chlorothiophen-2-yl)formamido]methyl}-2-oxo-1,3-oxazolidin-3-yl]phenyl}formamido]ethoxy}acetic acid | 1151893-81-0 | C24H21Cl2N3O7S2 |
|
| 利伐沙班杂质IV(潜在杂质) | N1,N2-bis[[(S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl]methyl]phthalamide | 1365267-36-2 | C36H36N6O10 |
|
| 利伐沙班杂质5 | (S)-2-(((2-oxo-3-(4-(3-oxomorpholin-4-yl)phenyl)oxazolidin-5-yl)methyl)carbamoyl)benzoic acid | 1365267-37-3 | C22H21N3O7 |
|
| 利伐沙班杂质49 | 2-((S)-3-chloro-2-hydroxypropyl)isoindoline-1,3-dione | 148857-42-5 | C11H10ClNO3 |
|
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