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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枸橼酸沃克拉丁 | Dorex | 52432-72-1 | C6H8O7*C20H33NO3 |
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林丹-13C6(Γ-BHC) | gamma-Hch 13C6 | 104215-85-2 | C6H6Cl6 |
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松果体素-D4 | deuterated melatonin | 66521-38-8 | C13H16N2O2 |
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来那度胺杂质3 | 2-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)glutaric acid | 295357-66-3 | C13H14N2O5 |
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来那度胺杂质2 | Methyl 5-amino-4-(4-amino-1-oxoisoindolin-2-yl)-5-oxopentanoate | 1198299-53-4 | C14H17N3O4 |
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来那度胺杂质12 | 2-(4-nitro-1-oxo-1,3-dihydroisoindol-2-yl)glutaric acid | 295357-72-1 | C13H12N2O7 |
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来氟米特杂质G(EP)标准品 | 5-methyl-isoxazole-4-carboxylic acid <i>p</i>-toluidide | 724429-16-7 | C12H12N2O2 |
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来氟米特杂质F | 5-Methyl-N-(2-(trifluoromethyl)phenyl)isoxazole-4-carboxamide | 1403564-06-6 | C12H9F3N2O2 |
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杜鲁特韦杂质5 | 4-Desfluoro-6-fluoro dolutegravir | 2244161-72-4 | C20H19F2N3O5 |
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杜克甙A | Dulcoside A | 64432-06-0 | C38H60O17 |
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杆菌肽A | Baciguent | 22601-59-8 | C66H103N17O16S |
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杂质帕瑞昔布H | Benzenesulfonamide, N-hydroxy-4-(5-methyl-3-phenyl-4-isoxazolyl)- | 501093-49-8 | C16H14N2O4S |
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杀螨醚 | chlorbenside | 103-17-3 | C13H10Cl2S |
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杀螨好 | p-chlorophenyl-2,4,5-trichlorophenylsulphide [Tetrasul] | 2227-13-6 | C12H6Cl4S |
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杀螟硫磷 | fenitrooxon | 2255-17-6 | C9H12NO6P |
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杀虫脒 盐酸盐 | chlordimeform hydrochloride | 19750-95-9 | C10H13ClN2*ClH |
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杀虫丹亚砜 | ethiofencarb-sulfoxide | 53380-22-6 | C11H15NO3S |
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木四糖 | β-D-Xylp-(1-4)-β-D-Xylp-(1-4)-β-D-Xylp-(1-4)-β-D-Xyl | 22416-58-6 | C20H34O17 |
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月见草素B | [11,37-Diformyl-4,5,6,14,20,21,22,25,26,30,31,32,44,45,46,49,50,56-octadecahydroxy-9,17,35,41,53,59-hexaoxo-38-(3,4,5-trihydroxybenzoyl)oxy-2,10,16,28,36,40,54,60-octaoxanonacyclo[37.11.6.413,27.03,8.018,23.029,34.042,47.048,52.024,58]hexaconta-1(50),3,5,7,18,20,22,24,26,29,31,33,42,44,46,48,51,57-octadecaen-12-yl] 3,4,5-trihydroxybenzoate | 104987-36-2 | C68H48O44 |
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月桂酸诺龙 | Nandrolone laurate | 26490-31-3 | C30H48O3 |
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月桂酸-d23 | lauric acid-d<sub>23</sub> | 59154-43-7 | C12H24O2 |
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替马西泮相关物质F | 7-Chlor-1-methyl-5-phenyl-4,5-dihydro-2H-1,4-benzodiazepin-2,3-(1H)-dion | 3294-96-0 | C16H13ClN2O2 |
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替诺福韦酯杂质37 | ethyl p-toluenesulfonyloxymethylphosphonate | 161760-03-8 | C10H15O6PS |
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替诺福韦酯杂质10 | N-(purine-6-yl)-1-amino-2-propanol | 16958-60-4 | C8H11N5O |
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替诺福韦杂质B | (R)-9-(1-methyl-2-hydroxyethyl)adeninde | 36817-69-3 | C8H11N5O |
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替诺福韦杂质113 | 4-pivaloylamino-7-iodo-3H,5H-pyrrolo[3,2-d]pyrimidine | 1335287-28-9 | C11H13IN4O |
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替诺福韦二聚 | 2,4,6,8-Tetraoxa-5-phosphanonanedioic acid, 5-[[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy]methyl]-, 1-methyl 9-(1-methylethyl) ester, 5-oxide | 1246812-43-0 | C17H26N5O10P |
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替诺福韦二乙酯 | (R)-9-[2-(diethylphosphonomethoxy)propyl]adenine | 180587-75-1 | C13H22N5O4P |
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替罗非班杂质丁二盐酸盐 | 1,5-di(4-pyridyl)pentane | 25382-33-6 | C15H18N2 |
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替罗非班杂质 | 4-(4-Chloro-butyl)-piperidine | 464175-13-1 | C9H18ClN |
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替罗非班-丁基-d9,盐酸盐 | Tirofiban-d9 Hydrochloride | 1331911-68-2 | C22H37ClN2O5S |
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替米沙坦氯代物 | 4'-[[5-chloro-1,7'-dimethyl-2'-propyl-1H,3'H-(2,5'-dibenzimidazolyl)-3'-yl]methyl]-(1,1'-biphenyl)-2-carboxylic acid | 885045-90-9 | C33H29ClN4O2 |
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替米沙坦杂质B | 4'-((7-Methyl-5-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H-benzimidazol-1-yl)methyl)biphenyl-2-carboxylic acid | 1026353-20-7 | C33H30N4O2 |
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替米沙坦杂质34 | 1-[4-N-butyrylamino-3-methyl-5-aminophenyl]-3N-methylbenzimidazole | 1083158-65-9 | C19H22N4O |
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替米沙坦N-去甲基杂质 | Desmethyl Telmisartan | 144701-81-5 | C32H28N4O2 |
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替米沙坦-d3 | 4-{[2-n-propyl-4-methyl-6-(1-methyl-d<sub>3</sub>-benzoimidazol-2-yl)benzoimidazol-1-yl]methyl}biphenyl-2-carboxylic acid | 1189889-44-8 | C33H30N4O2 |
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替比培南杂质 | S-(azetidin-3-yl) ethanethioate | 886615-18-5 | C5H9NOS |
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替格瑞洛羟基杂质 | (1S,2S,3R,5S)-3-(7-hydroxy-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol | 1445580-43-7 | C14H21N5O5S |
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替格瑞洛杂质H | (1S,2S,3R,5S)-3-[7-amino-5-(propylthio)-3H-1,2,3-triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)-1,2-cyclopentanediol | 1251765-07-7 | C14H22N6O4S |
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替格瑞洛杂质B | (1S,2S)-2-(3,4-Difluorophenyl)cyclopropanamine | 1459719-81-3 | C9H9F2N |
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替格瑞洛杂质44 | 4-chloro-6-methoxy-2-(propylthio)pyrimidin-5-amine | 1431867-40-1 | C8H12ClN3OS |
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替格瑞洛杂质27 | ethyl 2-((3aR,4S,6R,6aS)-6-(7-chloro-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-2,2-dimethyltetrahydro-3aH-cyclopenta[d][1,3]-dioxol-4-yloxy)acetate | 1402150-01-9 | C19H26ClN5O5S |
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替格瑞洛杂质27 | (1R,2S)-2-(4-fluorophenyl)cyclopropan-1-amine hydrochloride | 1314324-00-9 | C9H10FN*ClH |
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替格瑞洛杂质14 | N-[4,6-dichloro-2-(propylthio)pyrimidin-5-yl]formamide | 1402150-28-0 | C8H9Cl2N3OS |
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替格瑞洛杂质128 | (4R,5R)-2,2-dimethyl-5-vinyl-[1,3]dioxolane-4-carbaldehyde | 155934-55-7 | C8H12O3 |
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替格瑞洛杂质 | ethyl 2-((3aR,4S,6R,6aS)-6-amino-2,2-dimethyl-tetrahydro-3aH-cyclopenta[d][1,3]dioxol-4-yloxy)acetate | 1265919-24-1 | C12H21NO5 |
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替格瑞洛中间体1脱保护杂质 | (1S,2S,3R,5S)-3-(7-chloro-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol | 1354945-69-9 | C14H20ClN5O4S |
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替卡西林钠杂质A | 6β-(2-thiophen-3-yl-acetylamino)-penicillanic acid | 36041-93-7 | C14H16N2O4S2 |
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替卡西林钠 | Ticarcillin sodium | 29457-07-6 | C15H16N2NaO6S2 |
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替卡西林杂质A | (5-ethyl-2-thienyl)phenylmethanone | 6933-26-2 | C13H12OS |
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