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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克来范 | Kelevan | 4234-79-1 | C17H12Cl10O4 |
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克拉霉素杂质A | 16-Hydroxyclarithromycin | 124412-58-4 | C38H69NO14 |
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克拉霉素杂质 | N-Desmethyl-6-O-methylerythromycin (9E)-Oxime | 127182-43-8 | C37H68N2O13 |
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克拉霉素杂质 | N-Desmethyl Clarithromycin (9E)-Oxime | 101666-67-5 | C37H68N2O13 |
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克拉维酸盐EP杂质 | (2R,4R,5Z)-2-(Carboxymethyl)-5-(2-hydroxyethylidene)-3-[(2R,3Z,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carbonyl]-1,3-oxazolidine-4-carboxylic acid | 1260617-10-4 | C16H18N2O10 |
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克拉红霉素EP杂质I | 3-O-descladinosylclarithromycin | 118058-74-5 | C30H55NO10 |
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克拉珠利 | 2-chloro-α-(4-chlorophenyl)-4-(4,5-dihydro-3,5-dioxo-1,2,4-triazin-2(3H)-yl)benzeneacetonitrile | 101831-36-1 | C17H10Cl2N4O2 |
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克尼托喹 | desethylhydroxychloroquine | 4298-15-1 | C16H22ClN3O |
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克伦潘特盐酸盐 | Clenpenterol hydrochloride | 37158-47-7 | C13H21Cl3N2O |
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克伦丙罗-d7 | D7-clenproperol | 1173021-09-4 | C11H16Cl2N2O |
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克伦丙罗 | clenproperol | 38339-11-6 | C11H16Cl2N2O |
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光黃素 | lumiflavin | 1088-56-8 | C13H12N4O2 |
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光甾醇 | lumisterol | 474-69-1 | C28H44O |
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偶氮氯膦Ⅲ | chlorophosphonazo III | 1914-99-4 | C22H16Cl2N4O14P2S2 |
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假马齿苋苷X | Bacopaside X | 94443-88-6 | C46H74O17 |
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假马齿苋皂苷I | Bacopaside I | 382148-47-2 | C46H74O20S |
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倒千里光碱 | retrorsine | 480-54-6 | C18H25NO6 |
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倍他米松杂质5 | Betamethasone 21-(ethyl carbonate) | 52619-05-3 | C25H33FO7 |
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倍他米松EP杂质I | 8-Fluoro-11beta,17,21-trihydroxy-16beta-methyl-8alpha,9beta-pregna-1,4-diene-3,20-dione | 185613-69-8 | C22H29FO5 |
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倍他米松EP杂质H | 14-Fluoro-11beta,17,21-trihydroxy-16beta-methyl-8alpha,9beta,14beta-pregna-1,4-diene-3,20-dione | 185613-71-2 | C22H29FO5 |
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倍他米松EP杂质F | 17,21-Dihydroxy-16beta-methylpregna-1,4,11-triene-3,20-dione | 330157-04-5 | C22H28O4 |
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倍他米松9,11-环氧化物21-丙酸酯 | (9β,11β,16β)-9,11-epoxy-17-hydroxy-16-methyl-21-(1-oxopropoxy)pregna-1,4-diene-3,20-dione | 205105-83-5 | C25H32O6 |
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倍他米松17-丙酸酯21-甲磺酸酯 | betamethasone 17-propanoate 21-mesylate | 15423-80-0 | C26H35FO8S |
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倍他米松 17-苯甲酸酯 | betamethasone benzoate | 22298-29-9 | C29H33FO6 |
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依鲁替尼杂质6 | 1,3-bis((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)propan-1-one | 1987905-93-0 | C47H46N12O3 |
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依鲁替尼杂质37 | 3-iodo-1-(piperidin-4-yl)-1H-pyrazolo[3,4-d]pyrimidin-4-amine | 330793-49-2 | C10H13IN6 |
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依鲁替尼杂质 | 4-(pyridin-2-ylmethoxy)-phenylamine hydrochloride | 936351-48-3 | C12H12N2O*ClH |
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依鲁替尼代谢物 | Pci-45227 | 1654820-87-7 | C25H26N6O4 |
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依那普利杂质1 | enalapril | 76420-74-1 | C20H28N2O5 |
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依达拉奉杂质DO | 4-Hydroxy-3-methyl-1-phenyl-2-pyrazolin-5-on | 5393-61-3 | C10H10N2O2 |
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依达拉奉杂质12 | (E)-ethyl 3-(2-phenylhydrazono)butanoate | 2061958-41-4 | C12H16N2O2 |
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依达拉奉杂质 | 2-(3-methyl-5-oxo-1-phenyl-4,5-dihydro-1H-pyrazol-4-yl)-2-sulfopropanoic acid | 1357477-99-6 | C13H14N2O6S |
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依达拉奉杂质 | 3-acetoxy-crotonic acid ethyl ester | 29214-62-8 | C8H12O4 |
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依达拉奉三聚体 | 4,4-Bis-(3-methyl-phenyl-pyrazolin-5-on-4-yl)-3-methyl-1-phenyl-pyrazolin-5-on | 68195-63-1 | C30H26N6O3 |
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依诺沙星杂质3 | 7-chloro-1-ethyl-6-fluoro-1,4-dihydro-4-oxo-1,8-naphthyridine-3-carboxylic acid | 79286-73-0 | C11H8ClFN2O3 |
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依西美坦杂质B(EP) | 6-hydroxymethyl-androsta-1,4-diene-3,17-dione | 184972-09-6 | C20H26O3 |
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依莰舒 | terephthalylidene dicamphor sulfonic acid | 92761-26-7 | C28H34O8S2 |
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依维莫司杂质3 | (S)-1-{2-[(2R,3R,6S)-6-((3E,5E,7E)-(2S,9S,11R)-2,13-Dimethoxy-3,9,11-trimethyl-12-oxo-trideca-3,5,7-trienyl)-2-hydroxy-3-methyl-tetrahydro-pyran-2-yl]-2-oxo-acetyl}-piperidine-2-carboxylic acid | 147438-30-0 | C32H49NO9 |
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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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