在分析工作中,常需使用质量优良、含量准确的化合物作为检测对照比较或仪器校正之用,这类物质称为标准品,亦可称为标准物。
标准品概述 标准品主要用于测定生物制品的效价,生产部门在申报生物制品的质量标准时必须提供被检测的标准品效价,并以单位(μ)表示。根据用途不同,检验用标准品可分为两类:一种是用于生物检定的标准品,如供生物制品、内分泌药物及抗菌素等使用的;另一种是化学标准品,包括校正仪器用的、校正药品紫外或红外图谱用的以及作为药品纯度检查和杂质对照的标准品。《中华人民共和国药典1990年版》第一部分附录第67页提供了如乙酸龙脑酯、丁香酚及人参二醇等多种标准品与对照药材,供中药纯度检测或含量测定使用。
国际标准品 国际标准品是以原有国际标准品的效价单位为基准,在广泛国际合作中确定其效价单位。效价以1U表示。某一种物品的第一个国际标准品建立时,其效价单位需由专家委员会协商决定后公布,这些标准品是全球制备国家标准品的标准对照物质,使国际标准达到统一。
试剂与标准品 食品分析实验室所用的所有试剂都应贴有标签,并注明以下信息:名称、配制日期、负责人签字等必要内容。大多数食品分析工作均需使用标准品作为定性或定量检测的参照物。标准品按类型可分为国际标准品、国家标准品、企业内部标准品和其他标准品。
对于基准标准品,盛放容器应贴有标签以标明名称、标准品文件号、开启时间、有效期及负责人签字等信息。此外,实验室需保存所有基准标准品的相关专门文件。
容量分析用标准溶液 容量分析中使用的标准溶液管理也需严格把控。每个标准溶液的容器都须贴有明显标签,注明名称、浓度、配制日期、配制规程号、贮存条件、有效期及负责人签字等信息。
中文名称 | 英文名称 | CAS号 | 化学式 | 结构式图片 |
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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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依他硝唑 | etanidazole | 22668-01-5 | C7H10N4O4 |
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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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伪红霉素 A 烯醇醚 | 8,9-anhydropseudoerythromycin A 6,9-hemiketal | 105882-69-7 | C37H65NO12 |
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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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伐草克 | chlorfenac | 85-34-7 | C8H5Cl3O2 |
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伐灭磷 | famphur | 52-85-7 | C10H16NO5PS2 |
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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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伏马毒素B1 | fumonisin B1 | 116355-83-0 | C34H59NO15 |
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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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伊索昔康 | isoxicam | 34552-84-6 | C14H13N3O5S |
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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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伊立替康杂质29 | 7-ethyl-1,2,6,7-tetrahydro-20-(S)-camptothecin | 797762-11-9 | C22H24N2O4 |
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伊立替康杂质 | 1,4'-Bipiperidine, 1'-(phenylmethyl)- | 116269-53-5 | C17H26N2 |
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伊曲康唑杂质E | trans-Itraconazole | 252964-65-1 | C35H38Cl2N8O4 |
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伊曲康唑杂质B | 4-(4-(4-(4-(((2RS,4SR)-2-((4H-1,2,4-Triazol-4-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-2-sec-butyl-2H-1,2,4-triazol-3(4H)-one | 854372-77-3 | C35H38Cl2N8O4 |
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伊伐布雷定相关化合物9 | 7,8-dimethoxy-1H-3-benzazepine-2,4(3H,5H)-dione | 85175-49-1 | C12H13NO4 |
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伊伐布雷定杂质2单体 | 3-{3-[{[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl}(methyl)amino]propyl}-7,8-dimethoxy-1,3,4,5-tetrahydro-2H-3-benzazepin-2-oneOn | 1616710-52-1 | C27H34N2O6 |
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