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 |
|---|---|---|---|---|
| 泊沙康唑杂质5 | N1-{4-[4-(4-Hydroxyphenyl)piperazin-1-YL]phenyl}-1-[(1S,2S)-1-ethyl-2-methyl-3-phenoxypropyl]-1-hydrazinecarboxamide | 345217-02-9 | C29H37N5O3 |
|
| 泊沙康唑杂质39 | 4-[4-[4-[4-[[(3R,5R)-5-(2,4-difluorophenyl)-5-(1,2,4-triazol-1-ylmethyl)oxolan-3-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-pentan-3-yl-1,2,4-triazol-3-one | 161532-65-6 | C37H42F2N8O3 |
|
| 泊沙康唑杂质35 | (R)-1-((2-(2,4-difluorophenyl)-4-methylenetetrahydrofuran-2-yl)methyl)-1H-1,2,4-triazole | 1370190-85-4 | C14H13F2N3O |
|
| 泊沙康唑杂质18 | Posaconazole Impurity 18 | 1819334-66-1 | C44H49F2N8O4+ |
|
| 泊沙康唑中间体-7 | 2-[2-(2,4-difluorophenyl)-2-propen-1-yl]-1,3-propanediol | 165115-73-1 | C12H14F2O2 |
|
| 泊沙康唑 | 2-methylpropanoic acid [(2S)-4-(2,4-difluorophenyl)-2-hydroxymethyl-4-penten-1-yl] ester | 192448-07-0 | C16H20F2O3 |
|
| 沙美特罗杂质H | 1-Hydroxy-4-{[2-hydroxy-5-(1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl)phenyl]methyl}naphthalene-2-carboxylic acid | 1330076-52-2 | C36H43NO6 |
|
| 沙美特罗杂质F | 4-(1-hydroxy-2-((6-(4-phenylbutoxy)-hexyl)amino)ethyl)-2-methylphenol | 1391054-40-2 | C25H37NO3 |
|
| 沙美特罗杂质D | 4-(1-hydroxy-2-(4-(1-hydroxy-2-((6-(4-phenylbutoxy)hexyl)amino)ethyl)-2-(hydroxymethyl)-phenoxy)ethyl)-2-(hydroxymethyl)phenol | 1391052-04-2 | C34H47NO7 |
|
| 沙丁胺醇缩丙酮 | 2-(N-tert-butylamino)-1-(2,2-dimethyl-1,3-benzodioxin-6-yl)ethanol | 54208-72-9 | C16H25NO3 |
|
| 沙丁胺醇甲醚杂质 | 2-(Tert-butylamino)-1-[3-(hydroxymethyl)-4-methoxyphenyl]ethanol | 18910-69-5 | C14H23NO3 |
|
| 沃诺拉赞杂质43 | 5-phenyl-1-(pyridin-3-ylsulfonyl)-1H-pyrrole-3-carbaldehyde | 881676-90-0 | C16H12N2O3S |
|
| 沃替西汀杂质18 | N1-(2-Chloroethyl)-N2-(2-((2,4-dimethylphenyl)thio)phenyl)ethane-1,2-diamine | 1928741-88-1 | C18H23ClN2S |
|
| 沃替西汀杂质16 | (2,4-dimethylphenyl)(phenyl)sulfane | 16704-47-5 | C14H14S |
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| 水杨酰氯 | salicyloyl chloride | 1441-87-8 | C7H5ClO2 |
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| 水吡考他胺 | Picotamide monohydrate | 80530-63-8 | C21H22N4O4 |
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| 水合氧化前胡素 | 4-((<i>R</i>)-2,3-dihydroxy-3-methyl-butoxy)-furo[3,2-<i>g</i>]chromen-7-one | 2643-85-8 | C16H16O6 |
|
| 氯雷他定脱氯杂质 | ethyl 4-(5,6-dihydro-11H-benzo[5,6]cyclohepta-[1,2-b]pyridin-11-ylidene)piperidine-1-carboxylate | 79779-58-1 | C22H24N2O2 |
|
| 氯雷他定杂质I | ethyl 4-(8-chloro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)piperidine-1-carboxylate | 133330-56-0 | C22H21ClN2O2 |
|
| 氯雷他定杂质F | Fluoroloratadine | 125743-80-8 | C22H24ClFN2O2 |
|
| 氯雷他定杂质C | ethyl 4-(4,8-dichloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)piperidine-1-carboxylate | 165739-83-3 | C22H22Cl2N2O2 |
|
| 氯雷他定杂质26 | 4-[8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-yl]-1-methyl-1,2,5,6-tetrahydropyridine | 183198-48-3 | C20H21ClN2 |
|
| 氯雷他定杂质17 | 8-chloro-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ol | 133330-72-0 | C14H12ClNO |
|
| 氯雷他定杂质14 | 8-CHLORO-11-(1-ETHOXYCARBONYL-4-PIPERIDINYL)-11H-BENZO[5,6]CYCLOHEPTA(1,2-b)PYRIDINE | 169253-13-8 | C22H23ClN2O2 |
|
| 氯雷他定杂质 | 4,8-Dichloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-one | 133330-60-6 | C14H9Cl2NO |
|
| 氯诺昔康杂质9 | 5-chloro-3-(methylsulfamoyl)thiophene-2-carboxylic acid | 70374-36-6 | C6H6ClNO4S2 |
|
| 氯苯那敏杂质A | 2-(4-Chlorophenyl)-4-(dimethylamino)-2-(2-(dimethylamino)ethyl)butanenitrile | 1246816-57-8 | C16H24ClN3 |
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| 氯苯那敏杂质 | Chlorpheniramine-N-oxide | 120244-82-8 | C16H19ClN2O |
|
| 氯苯那敏杂质 | 2-(4-chloro-phenyl)-4-dimethylamino-butyronitrile | 73775-50-5 | C12H15ClN2 |
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| 氯胍相关物质D | 1,5-Bis(1-methylethyl)biguanide hydrochloride | 35708-82-8 | C8H20ClN5 |
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| 氯胍相关物质C | N1,N5-bis(4-chlorophenyl)biguanide hydrochloride | 13590-98-2 | C14H13Cl2N5*ClH |
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| 氯甲基二乙基氨基甲酸酯 | chloromethyl N,N-diethyl carbamate | 133217-92-2 | C6H12ClNO2 |
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| 氯甲基乙基碳酸酯 | chloromethyl ethyl carbonate | 35179-98-7 | C4H7ClO3 |
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| 氯甲基丙基碳酸酯 | chloromethyl propyl carbonate | 35273-90-6 | C5H9ClO3 |
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| 氯波必利 | Cleprid | 57645-91-7 | C4H6O5*C20H24ClN3O2 |
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| 氯沙坦钾EP杂质F | 5-(4'-((2-Butyl-4-chloro-5-(((1-methylethyl)oxy)methyl)-1H-imidazol-1-yl)methyl)biphenyl-2-yl)-1H-tetrazole | 1332713-64-0 | C25H29ClN6O |
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| 氯沙坦杂质M | N2-Losartanyl-losartan | 230971-72-9 | C44H44Cl2N12O |
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| 氯沙坦杂质J | O-Acetyl Losartan | 1006062-27-6 | C24H25ClN6O2 |
|
| 氯沙坦杂质C | 1H-Imidazole-4-methanol, 2-butyl-5-chloro-1-((2'-(2H-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)- | 114799-13-2 | C22H23ClN6O |
|
| 氯沙坦异构体杂质,钾盐 | Losartan Isomer Impurity, Potassium Salt | 860644-28-6 | C22H22ClKN6O |
|
| 氯氰碘柳胺钠 | closantel sodium | 61438-64-0 | C22H13Cl2I2N2O2*Na |
|
| 氯氨酮相关物质A | 1-((2-chlorophenyl)(methylimino)methyl)cyclopentanol | 6740-87-0 | C13H16ClNO |
|
| 氯尼辛杂质3 | 2-Chloro-N-(3-chloro-2-methyl-phenyl)-nicotinamide | 57841-61-9 | C13H10Cl2N2O |
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| 氯喹相关物质E | <i>N</i><sup>4</sup>,<i>N</i><sup>4</sup>-diethyl-<i>N</i><sup>1</sup>-(5-chloro-[4]quinolyl)-1-methyl-butanediyldiamine | 5428-61-5 | C18H26ClN3 |
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| 氯吡格雷酸 | clopidogrel carboxylic acid | 144457-28-3 | C15H14ClNO2S |
|
| 氯吡格雷杂质D | (2R)-(2-chlorophenyl) [(2S)-(2-chlorophenyl) [4,5,6,7-tetrahydrothieno[3,2-c]pyridin-5-yl]acetoxyl]methyl acetate | 1421283-60-4 | C24H21Cl2NO4S |
|
| 氯吡格雷杂质07 | (+)-α-(4,5,6,7-tetrahydrothieno[3,2-c]-5-pyridyl)-α-2-chlorophenylacetamide | 444728-13-6 | C15H15ClN2OS |
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| 氯吡格雷杂质 | (R)-methyl 2-(2-chlorophenyl)-2-(2-oxo-7,7a-dihydrothieno-[3,2-c]pyridin-5(2H,4H,6H)-yl)acetate | 1360923-54-1 | C16H16ClNO3S |
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| 氯吡格雷有关物质B | methyl 2-(2-chlorophenyl)-2-(4,5-dihydrothieno[2,3-c]pyridine-6(7H)-yl)acetate hydrochloride | 144750-52-7 | C16H16ClNO2S*ClH |
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| 氯吡格雷USP杂质C | methyl (S)-(+)-2-(2-chlorophenyl)-2-(6,7-dihydrothieno-[3,2-c]pyridin-5(4H)-yl)acetate bisulfate | 120202-71-3 | C16H16ClNO2S*H2O4S |
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