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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(1S,2R,5S)-6-(苄氧基)-7-氧代-1,6-二氮杂双环[3.2.1]辛烷-2-羧酸 | (2R,5S)-6-(benzyloxy)-7-oxo-1,6-diazabicyclo[3.2.1]octane-2-carboxylic acid | 1383814-70-7 | C14H16N2O4 |
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(1S,2R,3S)-阿瑞匹坦杂质 | 3-((3,5-bis(trifluoromethyl)phenethoxy)(4-fluorophenyl)(morpholino)methyl)-1H-1,2,4-triazol-5(4H)-one | 170902-81-5 | C23H21F7N4O3 |
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(1S,2R)-N,N-二乙基-2-(羟甲基)-1-苯基环丙烷甲酰胺 | (1 S,2 R)-N,N-diethyl-2-(hydroxymethyl)-1-phenylcyclopropane-carboxamide | 172015-99-5 | C15H21NO2 |
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(1S)-1-[(2S)-6-氟色满-2-基]-2-[[(2S)-2-[(2S)-6-氟色满-2-基]-2-羟基乙基]氨基]乙醇 | nebivolol | 118457-16-2 | C22H25F2NO4 |
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(1S)-1,5-脱水-1-C-[4-氯-3-[[4-[[(3S)-四氢-3-呋喃基]氧基]苯基]甲基]苯基]-D-葡萄糖醇 | methyl-1-C-(4-chloro-3-{4-[(3S)-tetrahydrofuran-3-yloxy]benzyl}phenyl)-D-glucopyranoside | 915095-96-4 | C24H29ClO8 |
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(1S)-1,5-脱水-1-C-[3-[[5-(4-氟苯基)-2-噻吩基]甲基]-4-甲基苯基]-D-山梨糖醇 2,3,4,6-四(2,2-二甲基丙酸酯) | (2S,3S,4R,5R,6R)-2-(3-((5-(4-fluorophenyl)thiophen-2-yl)methyl)-4-methylphenyl)-6-(pivaloyloxymethyl)tetrahydro-2H-pyran-3,4,5-triyl tris(2,2-dimethylpropanoate) | 1283129-18-9 | C44H57FO9S |
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(1R-4S)-4-[[(1,1-二甲基乙氧基)羰基]氨基]- 2-环戊烯-1-羧酸甲酯 | (1R,4S)-methyl 4-(tert-butoxycarbonylamino)cyclopent-2-enecarboxylate | 251326-99-5 | C12H19NO4 |
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(1R,5R,6R)-5-(1-乙丙基)-7-氮杂双环[4.1.0]庚-3-烯-3-羧酸乙酯 | ethyl-(1R,5R,6R)-5-(pentan-3-yloxy)-7-azabicyclo[4.1.0]hept-3-ene-3-carboxylate | 204255-02-7 | C14H23NO3 |
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(1R,4S)盐酸舍曲林 | trans-(1R,4S)-N-methyl-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-1-naphthalenamine hydrochloride | 79896-32-5 | C17H17Cl2N*ClH |
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(1R,4S)-4-(3,4-二氯苯基)-1,2,3,4-四氢-1-萘胺盐酸盐(1:1) | dasotraline hydrochloride | 675126-08-6 | C16H15Cl2N*ClH |
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(1R,3aR,7aR)-八氢-1-[(1R,2E,4S)-5-(甲氧基甲氧基)-1,4,5-三甲基-2-己烯-1-基]-7a-甲基-4H-茚-4-酮 | (22E,24S)-de-A,B-25-<(methoxymethyl)oxy>ergost-22-en-8-one | 100858-26-2 | C21H36O3 |
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(1R,3aR,7aR)-1-[(1R)-1,5-二甲基-5-[(三乙基硅烷基)氧基]己基]八氢-7a-甲基-4H-茚-4-酮 | 25-[(triethylsilyl)oxy]de-A,B-cholestan-8-one | 144848-24-8 | C24H46O2Si |
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(1R,3S)-索利那新杂质2 | (3S)-1-azabicyclo[2.2.2]oct-3-yl (1R)-3,4-dihydro-1-phenyl-2(1H)-isoquinolinecarboxylate | 774517-20-3 | C23H26N2O2 |
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(1R,3S)-1-(1,3-苯并二氧戊环-5-基)-2-(2-氯乙酰基)-2,3,4,9-四氢-1H-吡啶并[3,4-b]吲哚-3-羧酸甲酯 | (1R,3S)-1-benzo[1,3]dioxol-5-yl-2-(2-chloroacetyl)-2,3,4,9-tetrahydro-1H-β-carboline-3-carboxylic acid methyl ester | 629652-44-4 | C22H19ClN2O5 |
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(1R,3S)-1,2,3,4-四氢-1-(3,4-亚甲二氧基苯基)-9H-吡啶并[3,4-B]吲哚-3-羧酸甲酯盐酸盐他达那非杂质 | methyl (1R,3S)-1-(benzo[d][1,3]dioxol-5-yl)-2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indole-3-carboxylate | 171596-44-4 | C20H18N2O4 |
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(1R,3R,5R)-2-[(2S)-2-氨基-2-(3-羟基-1-金刚烷基)-1-羰基乙基]-2-氮杂双环[3.1.0]己烷-3-腈(沙格列汀中间体对应杂质) | (S)-3-hydroxyadamantylglycine-D-cis-4,5-methanoprolinenitrile | 1564265-94-6 | C18H25N3O2 |
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(1R,3R,5R)-2-[(2R)-2-氨基-2-(3-羟基-1-金刚烷基)-1-羰基乙基]-2-氮杂双环[3.1.0]己烷-3-腈(沙格列汀中间体对应杂质) | (R)-3-hydroxyadamantylglycine-D-cis-4,5-methanoprolinenitrile | 1564265-95-7 | C18H25N3O2 |
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(1R,3R)-索利那新杂质2 | (R)-quinuclidin-3-yl (R)-1-phenyl-3,4-dihydroisoquinoline-2(1H)-carboxylate | 740780-79-4 | C23H26N2O2 |
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(1R,2S,5R)-2-(氨基羰基)-7-氧代-1,6-二氮杂双环[3.2.1]辛-6-基硫酸酯(四丁基铵)盐 | tetrabutylammonium [(2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl] sulfate | 1192651-80-1 | C7H10N3O6S*C16H36N |
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(1R,2S,3S)-阿瑞匹坦 | 5-(((2S,3S)-2-((R)-1-(3,5-Bis(trifluoromethyl)phenyl)ethoxy)-3-(4-fluorophenyl)morpholino)methyl)-1H-1,2,4-triazol-3(2H)-one | 172822-28-5 | C23H21F7N4O3 |
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(1R,2S,3R)-阿瑞匹坦 | aprepitant | 1185502-97-9 | C23H21F7N4O3 |
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(1R,2S)-rel-2-(3,4-二氟苯基)环丙基甲酸 | (1R,2R)-2-(3,4-difluorophenyl)cyclopropane carboxylic acid | 220352-36-3 | C10H8F2O2 |
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(1R,2S)-2-(3-氟苯基)环丙胺 | (1R,2S)-2-(3-fluorophenyl)cyclopropanamine | 220353-83-3 | C9H10FN |
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(1R,2S)-2-(3,4-二氟苯基)环丙胺盐酸盐 | (1R,2S)-2-(3,4-difluorophenyl)cyclopropanamine hydrochloride | 1402222-66-5 | C9H9F2N*ClH |
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(1R,2R,5R)-(+)-2-羟基-3-蒎烷酮 | (-)-(2R,3R,5R)-2-hydroxy-3-pinanone | 1845-25-6 | C10H16O2 |
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(1R,2R,4S)-2-N-BOC-氨基-4-二甲胺羰基环己基甲磺酸酯 | (1R,2R,4S)-2-[(tert-butoxycarbonyl)amino]-4-[(dimethylamino)carbonyl]cyclohexyl methanesulfonate | 929693-31-2 | C15H28N2O6S |
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(1E,5E)-N,N'-二[(五氟苄基)氧基]-1,5-戊烷二亚胺 | Glutaraldehyde bis-(O-pentafluorophenylmethyloxime) | 932710-48-0 | C19H12F10N2O2 |
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(17beta)-雌甾-1,3,5(10),9(11)-四烯-3,17-二醇 | estra-1,3,5(10),9(11)-tetraene-3,17β-diol | 791-69-5 | C18H22O2 |
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(17alpha)-3,3-[1,2-乙烷二基二(氧基)]-17-羟基-19-去甲孕甾-5(10),9(11)-二烯-21-腈 | 17α-cyanomethyl-17β-hydroxy-5,9-androstadiene-3,17-dione-3,3-ethylene ketal | 190662-30-7 | C22H29NO3 |
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(17alpha)-17-羟基-3-氧代-19-去甲孕甾-5(10),9(11)-二烯-21-腈 | 17α-Cyanomethyl-17β-hydroxy-estra-5(10),9(11)-dien-3-on | 106111-42-6 | C20H25NO2 |
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(17a)-17-羟基-3-甲氧基-19-去甲孕甾-1,3,5(10)-三烯-21-腈 | 17α-cyanomethyl-1,3,5(10)-estratriene-3,17-diol 3-methyl ether | 24284-84-2 | C21H27NO2 |
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(16beta)-17,21-二羟基-16-甲基孕甾-1,4,9(11)-三烯-3,20-二酮 | 17α,21-dihydroxy-16β-methylpregna-1,4,9(11)-triene-3,20-dione | 13504-15-9 | C22H28O4 |
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(15R)-比马前列素 | (5Z)-N-ethyl-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-[(1E,3R)-3-hydroxy-5-phenyl-1-pentenyl]-cyclopentyl]hept-5-enamide | 1163135-92-9 | C25H37NO4 |
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(12Z)-12-十八碳烯酸甲酯 | cis-12-octadecenoic acid methyl ester | 2733-86-0 | C19H36O2 |
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(11beta,17alpha)-11-氢过氧基-17-羟基-3-氧代-19-去甲孕甾-4,9-二烯-21-腈 | Dienogest Impurity K (11beta-Hydroperoxy Dienogest) | 106111-43-7 | C20H25NO4 |
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(11beta,16alpha)-9-氯-11,21-二羟基-16,17-[(1-甲基亚乙基)二(氧基)]-孕甾-1,4-二烯-3,20-二酮 | 9-Chloro Triamcinolone Acetonide | 10392-74-2 | C24H31ClO6 |
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(11Z,14Z)-11,14-二十碳二烯酸甲酯 | (11Z,14Z)-11,14-icosadienoic acid methyl ester | 61012-46-2 | C21H38O2 |
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(1-重氮基-2-氧代丙基)膦酸二甲酯 | Dimethyl 1-diazo-2-oxopropylphosphonate | 90965-06-3 | C5H9N2O4P |
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(1-苄基哌啶-4-基)N-(2-苯基苯基)氨基甲酸酯 | 1-benzyl-4-piperidylbiphenyl-2-ylcarbamate | 171723-80-1 | C25H26N2O2 |
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(1-羟环己基)(4-甲氧基苯基)乙腈 | 1-[cyano(4-methoxyphenyl)methyl]cyclohexanol | 93413-76-4 | C15H19NO2 |
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(1-溴乙基)苯-D3 | 1-phenylethyl-2,2,2-d3 bromide | 23088-42-8 | C8H9Br |
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(1,1-二氧化-3-氧代-1,2-苯异噻唑-2(3h)-基)乙酸 | 2-(1,1-dioxido-3-oxobenzo[d]isothiazol-2(3H)-yl)acetic acid | 52188-11-1 | C9H7NO5S |
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(-)-氨甲蝶呤 | methotrexate | 51865-79-3 | C20H22N8O5 |
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(-)-N-(1(r)-苯基乙基)-1-氮杂双环[2.2.2]辛烷-3(s)-胺双盐酸盐 | (-)-N-(1(R)-Phenylethyl)-1-azabicyclo[2.2.2]octan-3(S)-amine dihydrochloride | 128311-06-8 | C15H24Cl2N2 |
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(-)-8-苯基薄荷醇 | (-)-8-phenylmenthol | 65253-04-5 | C16H24O |
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(-)-4-萜品醇 | (-)-terpinen-4-ol | 20126-76-5 | C10H18O |
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(-)-3-去甲基秋水仙碱 | 3-demethylcolchicine | 7336-33-6 | C21H23NO6 |
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(+/-)-二氢硫辛酸 | dihydrolipoic acid | 462-20-4 | C8H16O2S2 |
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(+/-)-alpha-硫辛酰胺 | lipoamide | 940-69-2 | C8H15NOS2 |
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(+)-表儿茶素 | (+)-epicatechin | 35323-91-2 | C15H14O6 |
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