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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
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
依泽替米贝(RRR)-异构体
依替菲宁 etifenin 63245-28-3 C16H22N2O5
依替菲宁
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
依折麦布杂质J
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
依折麦布杂质1
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
依托考昔杂质8
依托考昔杂质39 2-(4-methylsulfanylphenyl)-1-(morpholin-4-yl)ethanethione 107825-28-5 C13H17NOS2
依托考昔杂质39
依托考昔N1’-氧化物 Etoricoxib-1'-N-Oxide 325855-74-1 C18H15ClN2O3S
依托考昔N1’-氧化物
依托泊苷杂质B Etoposide Impurity B 100007-56-5 C29H32O13
依托泊苷杂质B
依托昔布杂质H N,N,6'-Trimethyl-3-(4-(methylsulfonyl)phenyl)-[2,3'-bipyridin]-5-amine 646459-39-4 C20H21N3O2S
依托昔布杂质H
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
依托昔布杂质13
依托度昔布杂质I 5-Chloro-3-(4-(methylsulfonyl)phenyl)-2-(3-pyridinyl)pyridine 202409-31-2 C17H13ClN2O2S
依托度昔布杂质I
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
依度沙班杂质SSS
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
依度沙班杂质H
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
依度沙班杂质F(单体)
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
依度沙班杂质65
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
依度沙班杂质26
依度沙班杂质16 tert-butyl [(1R,2S,5S)-2-azido-5-[(dimethylamino)carbonyl]cyclohexyl]carbamate 480450-69-9 C14H25N5O3
依度沙班杂质16
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
依度沙班杂质11
依度沙班杂质1 ethyl 2-oxo-2-(2-pyridylamino)acetate 41374-72-5 C9H10N2O3
依度沙班杂质1
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
依度沙班异构体B
依度沙班中间体 ethyl 2-((5-chloropyridin -2-yl)amino)-2-oxoacetate 349125-08-2 C9H9ClN2O3
依度沙班中间体
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
依匹哌唑硫氧化杂质
依匹哌唑杂质6 4-(4-(benzo[b]thien-4-yl)piperazin-1-yl)butan-1-ol 913614-15-0 C16H22N2OS
依匹哌唑杂质6
依匹哌唑杂质49 4-(piperazin-1-yl)benzo[b]thiophene-2-carboxylic acid 1700655-67-9 C13H14N2O2S
依匹哌唑杂质49
依匹哌唑杂质37 1-(benzo[b]thiophen-5-yl)piperazine 433303-94-7 C12H14N2S
依匹哌唑杂质37
依匹哌唑中间体体杂质 1,4-Di(benzo[b]thiophen-4-yl)piperazine 1420987-86-5 C20H18N2S2
依匹哌唑中间体体杂质
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
佩拉米韦杂质18
佐匹克隆氧化物 Zopiclone N-oxide 43200-96-0 C17H17ClN6O4
佐匹克隆氧化物
低聚物癸基辛基苷类 decyl glucoside 54549-25-6 C16H32O6
低聚物癸基辛基苷类
伯舒替尼杂质10 2-(3-bromopropoxy)-1-methoxy-4-nitrobenzene 219786-51-3 C10H12BrNO4
伯舒替尼杂质10
伪阿卡波糖 Pseudoacarbose 196944-81-7 C25H43NO17
伪阿卡波糖
伪单胞菌酸F DE(8-carboxyoctyl)6-carboxyhexylmupirocin 167842-64-0 C24H40O9
伪单胞菌酸F
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
伪单胞菌酸C
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
伐昔洛韦杂质
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
伐地那非氧代哌嗪
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
伐地那非杂质D
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
伐地那非杂质4
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
伐地那非杂质3
伐地那非杂质13HCL 2-ethoxybenzimidohydrazide 889943-46-8 C9H13N3O
伐地那非杂质13HCL
伐地那非乙酰基类似物 Acetylvardenafil 1261351-28-3 C25H34N6O3
伐地那非乙酰基类似物
伐地考昔 3-(5-methyl-4-phenylisoxazol-3-yl)benzenesulfonamide 1373038-56-2 C16H14N2O3S
伐地考昔
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
伏立康唑杂质19
伊马替尼杂质7 (2-methyl-5-aminophenyl)guanidine 581076-64-4 C8H12N4
伊马替尼杂质7
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
伊马替尼杂质4
伊贝碱甙A 6-Oxocevan-2-yl hexopyranoside 98985-24-1 C33H53NO7
伊贝碱甙A
伊贝沙坦杂质 A 1-pentanamido-N-[2'-(1H-tetrazol-5-yl)biphenyl-4-ylmethyl]cyclopentanecarboxamide 748812-53-5 C25H30N6O2
伊贝沙坦杂质 A
伊索拉定杂质9 2-(2',5'-Dichlorphenyl)-4,6-dihydroxy-1,3,5-triazin 30222-00-5 C9H5Cl2N3O2
伊索拉定杂质9
伊索克酸甲醛杂质 11-oxo-6,11-dihydrodibenzo[b,e]oxepine-2-carbaldehyde 66801-46-5 C15H10O3
伊索克酸甲醛杂质
伊索克酸乙醇杂质 2-(6,11-dihydro-11-oxodibanz<b,c>oxepin-2-yl)ethanol 87486-88-2 C16H14O3
伊索克酸乙醇杂质
伊索克酸 isoxepac 55453-87-7 C16H12O4
伊索克酸