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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阿托伐他汀钙杂质43 | (3R,5S)-Atorvastatin Acetonide tert-Butyl Ester | 947249-30-1 | C40H47FN2O5 |
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阿托伐他汀缩丙酮 | 2-((4R,6R)-6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetic acid | 581772-29-4 | C36H39FN2O5 |
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阿托伐他汀相关化合物E | 1105067-88-6 | C33H35CaFN2O5 |
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阿托伐他汀甲酯 | atorvastatin methyl ester | 345891-62-5 | C34H37FN2O5 |
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阿托伐他汀环氧乙烷杂质 | 3-(4-Fluorobenzoyl)-2-(2-methylpropyl)-N,3-diphenyloxirane-2-carboxamide | 1246818-88-1 | C26H24FNO3 |
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阿托伐他汀环(氟苯基)钠盐杂质 | ATV-FX1 sodium salt | 1315629-79-8 | C33H34FN2NaO7 |
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阿托伐他汀杂质D | 3-<(4-fluorophenyl)carbonyl>-2-(2-methyl-1-oxopropyl)-N,3-diphenyl-2-oxiranecarboxamide | 148146-51-4 | C26H22FNO4 |
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阿托伐他汀杂质7 | (3R,5R)-7-[5-(4-Fluoro-phenyl)-3-isopropyl-2-oxo-4-phenyl-3-phenylcarbamoyl-2,3-dihydro-pyrrol-1-yl]-3,5-dihydroxy-heptanoic acid | 906552-18-9 | C33H35FN2O6 |
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阿托伐他汀杂质5 | (4R-cis)-1,1-Dimethylethyl 6-[2[2-(fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]ethyl]-2,2-dimethyl-1,3-dioxane-4-acetate | 1099474-28-8 | C40H47FN2O5 |
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阿托伐他汀杂质1 | Atorvastatin, (3S,5R)- | 887324-52-9 | C31H37N2O5Pol |
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阿托伐他汀叔丁酯 | (3R,5R)-7-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-phenylcarbamoylpyrrol-1-yl]-3,5-dihydroxyheptanoic acid t-butyl ester | 134395-00-9 | C37H43FN2O5 |
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阿托伐他汀内酯 | atorvastatin lactone | 125995-03-1 | C33H33FN2O4 |
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阿托伐他汀乙酯 | ethyl (3R,5R)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate | 1146977-93-6 | C35H39FN2O5 |
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阿托伐他汀USP相关物质E | (-)-Atorvastatin | 501121-34-2 | C33H35FN2O5 |
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阿托伐他汀3-羟基消除杂质 | (2E,5S)-7-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrol-1-yl]-5-hydroxyhept-2-enoic acid | 1105067-93-3 | C33H33FN2O4 |
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阿托伐他汀3-氧杂质 | 3-oxo atorvastatin | 887196-30-7 | C33H33FN2O5 |
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阿扑长春胺 | apovincamine | 4880-92-6 | C21H24N2O2 |
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阿扎胞苷杂质37 | 1-(β-L-ribofuranosyl)-5-azacytosine | 206269-46-7 | C8H12N4O5 |
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阿扎胞苷杂质31 | 2,3,5-tri-O-acetyl-β-D-ribofuranose | 65024-85-3 | C11H16O8 |
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阿扎胞苷杂质-2 | 1-β-D-Ribofuranosyl-3-guanylharnstoff | 2508-80-7 | C7H14N4O5 |
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阿扎胞苷杂质-1 | N-[(N'-Formylcarbamimidoyl)carbamoyl]-D-ribofuranosylamine | 686299-20-7 | C8H14N4O6 |
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阿扎哌醇 | (R)-(+)-α-(4-fluorophenyl)-4-(2-pyridinyl)-1-piperazinebutanol | 2804-05-9 | C19H24FN3O |
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阿戈美拉汀杂质醇(A) | 7-methoxy-1,2,3,4-tetrahydro-1-naphthol | 32820-10-3 | C11H14O2 |
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阿戈美拉汀杂质05 | N-[2-(7-methoxy-3,4-dihydro-naphthalen-1-yl)ethyl]acetamide | 1352139-51-5 | C15H19NO2 |
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阿戈美拉汀杂质02 | 2-(7-methoxy-3,4-dihydro-1-naphthyl)ethylamine | 1353428-89-3 | C13H17NO |
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阿戈美拉汀杂质 | 7-Methoxy-tetralin-essigsaeure-(1)-amid | 92041-01-5 | C13H17NO2 |
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阿戈美拉汀杂质 | N-[2-(7-methoxy-3-hydroxynaphth-1-yl)ethyl]-acetamide | 166526-99-4 | C15H17NO3 |
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阿戈美拉汀二聚体乙酰胺 | N,N-bis[2-(7-methoxynaphthalen-1-yl)-ethyl]acetamide | 1385018-58-5 | C28H29NO3 |
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阿德福韦酯杂质E | Ethyl Ester of 9-(2-Phosphonylmethoxyethyl)adenine | 116384-54-4 | C10H16N5O4P |
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阿巴卡韦相关物质D | o-Pyrimidine derivative abacavir | 1443421-69-9 | C18H21ClN10O |
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阿巴卡韦相关化合物B(USP) | (1S, 4R)-(4-(2,5-diamino-6-chloro-4-pyrimidinyl)amino)-2-cyclopenten-1-methanol | 141271-12-7 | C10H14ClN5O |
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阿巴卡韦杂质F | 9-((1R,4S)-4-(tert-Butoxymethyl)cyclopent-2-enyl)-N6-cyclopropyl-9H-purine-2,6-diamine | 1443421-68-8 | C18H26N6O |
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阿尔法骨化醇中间体 | (1R,3aS,7aR)-4-[2-[(3S,5R)-3,5-Bis-(tert-butyl-dimethyl-silanyloxy)-2-methylene-cyclohex-(E)-ylidene]-eth-(E)-ylidene]-1-((R)-1,5-dimethyl-hexyl)-7a-methyl-octahydro-indene | 112670-85-6 | C39H72O2Si2 |
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阿尔法骨化醇N-1的BETA杂质 | (5E)-1beta-hydroxyvitamin D3/(5E)-1beta-hydroxycholecalciferol | 65445-15-0 | C27H44O2 |
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阿尔噻嗪 | althiazide | 5588-16-9 | C11H14ClN3O4S3 |
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阿奇霉素氮氧化物 | azithromycin N-oxide | 90503-06-3 | C38H72N2O13 |
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阿奇霉素杂质M | 3'-(N,N-Didemethyl)-3'-N-formylazithromycin | 765927-71-7 | C37H68N2O13 |
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阿奇霉素杂质K | Azithromycin E | 612534-95-9 | C38H70N2O13 |
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阿奇霉素杂质B | thioxanthene | 261-31-4 | C13H10S |
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阿奇霉素杂质18 | N-[(2S,3R,4S,6R)-2-[[(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-ethyl-3,4,10-trihydroxy-13-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydropyran-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-15-oxo-1-oxa-6-azacyclopentadec-11-yl]oxy]-3-hydroxy-6-methyltetrahydropyran-4-yl]-N,4-dimethylbenzenesulfonamide | 612069-31-5 | C44H76N2O14S |
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阿奇霉素杂质10 | 9-deoxo-9a-aza-9a-methyl-9a-homoerythronolide | 117693-42-2 | C22H43NO7 |
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阿奇霉素C(3′′-O-去甲基阿奇霉素) | Azithromycin C | 620169-47-3 | C37H70N2O12 |
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阿奇霉素B | Azithromycin B | 307974-61-4 | C38H72N2O11 |
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阿塞那平杂质C | 5-Chloro-2,3-dihydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrol-1-one | 129385-61-1 | C17H10ClNO3 |
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阿哌沙班杂质S3 | 5,6-dihydro-3-(4-morpholinyl)-1-[4-(2-oxo-6-methyl-1-piperidinyl)phenyl]-2(1H)-pyridone | 2098457-93-1 | C21H27N3O3 |
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阿哌沙班杂质61 | methyl 4-mercaptobutanoate | 39257-91-5 | C5H10O2S |
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阿哌沙班杂质52 | 1-(4-benzyloxy-phenyl)-7-oxo-6-[4-(2-oxo-piperidin-1-yl)-phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylic acid amide | 1620494-31-6 | C31H29N5O4 |
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阿哌沙班杂质51 | 1-(4-benzyloxy-phenyl)-7-oxo-6-[4-(2-oxo-piperidin-1-yl)-phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylic acid ethyl ester | 1620494-29-2 | C33H32N4O5 |
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阿哌沙班杂质26 | 6-(4-(5-chloropentanamido)phenyl)-1-(4-methoxyphenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide | 1449510-64-8 | C25H26ClN5O4 |
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阿哌沙班杂质15 | 6-(4-aminophenyl)-1-(4-methoxyphenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide | 1423803-24-0 | C20H19N5O3 |
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