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 |
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依泽替米贝(RRR)-异构体 | (3R,4R)-1-(4-Fluorophenyl)-3-((R)-3-(4-fluorophenyl)-3-hydroxypropyl)-4-(4-hydroxyphenyl)azetidin-2-one | 1593542-96-1 | C24H21F2NO3 |
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依替菲宁 | etifenin | 63245-28-3 | C16H22N2O5 |
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依折麦布杂质J | (3R,4S)-1-(4-Chlorophenyl)-3-[(S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidine-2-one | 1700622-08-7 | C24H21ClFNO3 |
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依折麦布杂质1 | (3R,4S)-1-(4-fluorophenyl)-3-((S)-3-hydroxy-3-phenylpropyl)-4-(4-hydroxyphenyl)azetidin-2-one | 190595-66-5 | C24H22FNO3 |
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依托考昔杂质8 | 1-(6-methylpyridin-3-yl)-2-({4-[2-(6-methylpyridin-3-yl)-2-oxoethyl]phenyl}sulfonyl)ethanone | 1421227-97-5 | C22H20N2O4S |
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依托考昔杂质39 | 2-(4-methylsulfanylphenyl)-1-(morpholin-4-yl)ethanethione | 107825-28-5 | C13H17NOS2 |
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依托考昔N1’-氧化物 | Etoricoxib-1'-N-Oxide | 325855-74-1 | C18H15ClN2O3S |
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依托泊苷杂质B | Etoposide Impurity B | 100007-56-5 | C29H32O13 |
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依托昔布杂质H | N,N,6'-Trimethyl-3-(4-(methylsulfonyl)phenyl)-[2,3'-bipyridin]-5-amine | 646459-39-4 | C20H21N3O2S |
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依托昔布杂质13 | 2-((4-(5-chloro-6'-methyl-[2,3'-bipyridine]-3-yl)phenyl)sulfonyl)-1-(6-methylpyridin-3-yl)ethanone | 1817735-82-2 | C25H20ClN3O3S |
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依托度昔布杂质I | 5-Chloro-3-(4-(methylsulfonyl)phenyl)-2-(3-pyridinyl)pyridine | 202409-31-2 | C17H13ClN2O2S |
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依度沙班杂质SSS | N1-(5-chloropyridin-2-yl)-N2-((1S,2S,4S)-4-[(dimethylamino)carbonyl]-2-{[(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl)ethanediamide | 1255529-27-1 | C24H30ClN7O4S |
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依度沙班杂质H | N1-(5-chloropyridin-2-yl)-N2-((1S,2S,4R)-4-[(dimethylamino)carbonyl]-2-{[(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl)ethanediamide | 1255529-28-2 | C24H30ClN7O4S |
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依度沙班杂质F(单体) | N<sup>1</sup>-[(1S,2R,4S)-2-amino-4-[(dimethylamino)carbonyl]cyclohexyl]-N<sup>2</sup>-(5-chloro-2-pyridyl)ethanediamide | 480452-37-7 | C16H22ClN5O3 |
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依度沙班杂质65 | 2-[((1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-{[(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl)amino]-2-oxoacetic acid ethyl ester | 480450-85-9 | C21H31N5O5S |
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依度沙班杂质26 | (1S,2R,5R)-2-({2-[(5-chloropyridin-2-yl)amino]-2-oxoacetyl}amino)-5-[(dimethylamino)carbonyl]cyclohexylcarbamic acid tert-butyl ester | 1255529-33-9 | C21H30ClN5O5 |
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依度沙班杂质16 | tert-butyl [(1R,2S,5S)-2-azido-5-[(dimethylamino)carbonyl]cyclohexyl]carbamate | 480450-69-9 | C14H25N5O3 |
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依度沙班杂质11 | tert-butyl (1R,2R,5S)-2-({2-[(5-chloropyridin-2-yl)amino]-2-oxoacetyl}amino)-5-[(dimethylamino)carbonyl]cyclohexylcarbamate | 480451-98-7 | C21H30ClN5O5 |
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依度沙班杂质1 | ethyl 2-oxo-2-(2-pyridylamino)acetate | 41374-72-5 | C9H10N2O3 |
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依度沙班异构体B | Ethanediamide, n1-(5-chloro-2-pyridinyl)-n2-[(1r,2s,4s)-4-[(dimethylamino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]cyclohexyl]- | 1255529-25-9 | C24H30ClN7O4S |
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依度沙班中间体 | ethyl 2-((5-chloropyridin -2-yl)amino)-2-oxoacetate | 349125-08-2 | C9H9ClN2O3 |
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依匹哌唑硫氧化杂质 | 2(1H)-Quinolinone, 7-(4-(4-(1-oxidobenzo(b)thien-4-yl)-1-piperazinyl)butoxy)- | 1191900-51-2 | C25H27N3O3S |
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依匹哌唑杂质6 | 4-(4-(benzo[b]thien-4-yl)piperazin-1-yl)butan-1-ol | 913614-15-0 | C16H22N2OS |
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依匹哌唑杂质49 | 4-(piperazin-1-yl)benzo[b]thiophene-2-carboxylic acid | 1700655-67-9 | C13H14N2O2S |
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依匹哌唑杂质37 | 1-(benzo[b]thiophen-5-yl)piperazine | 433303-94-7 | C12H14N2S |
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依匹哌唑中间体体杂质 | 1,4-Di(benzo[b]thiophen-4-yl)piperazine | 1420987-86-5 | C20H18N2S2 |
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佩拉米韦杂质18 | (1S,4S)-N-tert-butoxycarbonyl-4-aminocyclopent-2-ene-1-carboxylic acid methyl ester | 298716-04-8 | C12H19NO4 |
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佐匹克隆氧化物 | Zopiclone N-oxide | 43200-96-0 | C17H17ClN6O4 |
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低聚物癸基辛基苷类 | decyl glucoside | 54549-25-6 | C16H32O6 |
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伯舒替尼杂质10 | 2-(3-bromopropoxy)-1-methoxy-4-nitrobenzene | 219786-51-3 | C10H12BrNO4 |
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伪阿卡波糖 | Pseudoacarbose | 196944-81-7 | C25H43NO17 |
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伪单胞菌酸F | DE(8-carboxyoctyl)6-carboxyhexylmupirocin | 167842-64-0 | C24H40O9 |
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伪单胞菌酸C | 9-(((E)-4-((2S,3R,4R,5S)-3,4-dihydroxy-5-((4R,5S,E)-5-hydroxy-4-methylhex-2-en-1-yl)tetrahydro-2H-pyran-2-yl)-3-methylbut-2-enoyl)oxy)nonanoic acid | 71980-98-8 | C26H44O8 |
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伐昔洛韦杂质 | 2,2'-[methylenebis[imino(6-oxo-1,6-dihydro-9H-purine-9,2-diyl)methyleneoxy]]diethyl di(L-valinate) | 1356019-51-6 | C27H40N12O8 |
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伐地那非氧代哌嗪 | 2-{2-ethoxy-5-[(3-oxo-1-piperazinyl)sulfonyl]phenyl}-5-methyl-7-propylimidazo[5,1-f]-1,2,4-triazin-4(3H)-one | 448184-58-5 | C21H26N6O5S |
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伐地那非杂质D | 2,2'-[(piperazine-1,4-disulfonyl)bis(2-ethoxy-5,1-phenylene)]-bis[5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(3H)-one] | 1255919-03-9 | C38H46N10O8S2 |
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伐地那非杂质4 | {[2-({[4-ethoxy-3-(5-methyl-4-oxo-7-propyl-3,4-dihydroimidazo[5,1-f]-1,2,4-triazin-2-yl)phenyl]sulfonyl}amino)ethyl]amino}(oxo)acetic acid | 448184-56-3 | C21H26N6O7S |
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伐地那非杂质3 | 2-[2-ethoxy-5-(4-ethylpiperazine-1-sulfonyl)phenyl]-5-methyl-7-phenyl-3H-imidazo[5,1-f] [1,2,4]triazin-4-one | 1255919-01-7 | C26H30N6O4S |
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伐地那非杂质13HCL | 2-ethoxybenzimidohydrazide | 889943-46-8 | C9H13N3O |
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伐地那非乙酰基类似物 | Acetylvardenafil | 1261351-28-3 | C25H34N6O3 |
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伐地考昔 | 3-(5-methyl-4-phenylisoxazol-3-yl)benzenesulfonamide | 1373038-56-2 | C16H14N2O3S |
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伏立康唑杂质19 | 2-(2,4difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)-butan-2-ol-R(-)-10-camphor sulphonate | 321589-01-9 | C26H28F3N5O4S |
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伊马替尼杂质7 | (2-methyl-5-aminophenyl)guanidine | 581076-64-4 | C8H12N4 |
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伊马替尼杂质4 | 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-methyl-6-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide | 942514-62-7 | C30H33N7O |
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伊贝碱甙A | 6-Oxocevan-2-yl hexopyranoside | 98985-24-1 | C33H53NO7 |
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伊贝沙坦杂质 A | 1-pentanamido-N-[2'-(1H-tetrazol-5-yl)biphenyl-4-ylmethyl]cyclopentanecarboxamide | 748812-53-5 | C25H30N6O2 |
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伊索拉定杂质9 | 2-(2',5'-Dichlorphenyl)-4,6-dihydroxy-1,3,5-triazin | 30222-00-5 | C9H5Cl2N3O2 |
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伊索克酸甲醛杂质 | 11-oxo-6,11-dihydrodibenzo[b,e]oxepine-2-carbaldehyde | 66801-46-5 | C15H10O3 |
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伊索克酸乙醇杂质 | 2-(6,11-dihydro-11-oxodibanz<b,c>oxepin-2-yl)ethanol | 87486-88-2 | C16H14O3 |
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伊索克酸 | isoxepac | 55453-87-7 | C16H12O4 |
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