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标准品

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
—— 3-Cyclobutene-1,2-dione, 3-hydroxy-, sodium salt 71376-34-6 C4HNaO3
3-Cyclobutene-1,2-dione, 3-hydroxy-, sodium salt
—— Deoxynivalenol-13C15 911392-36-4 C15H20O6
Deoxynivalenol-13C15
—— trans-nonachlor 39765-80-5 C10H5Cl9
trans-nonachlor
—— (1R,7aR)-7a-methyl-1-[(2R)-6-methyl-6-trimethylsilyloxyheptan-2-yl]-2,3,3a,5,6,7-hexahydro-1H-inden-4-one 81506-41-4 C21H40O2Si
(1R,7aR)-7a-methyl-1-[(2R)-6-methyl-6-trimethylsilyloxyheptan-2-yl]-2,3,3a,5,6,7-hexahydro-1H-inden-4-one
—— 2-[2-(2,2-Diphenylacetyl)-2,3-dihydro-3-oxo-1H-inden-1-ylidene]hydrazone Formaldehyde 1119449-21-6 C24H18N2O2
2-[2-(2,2-Diphenylacetyl)-2,3-dihydro-3-oxo-1H-inden-1-ylidene]hydrazone Formaldehyde
—— Sodium o-iodohippurate 51888-80-3 C9H7INNaO3
Sodium o-iodohippurate
—— verruculogen 12771-72-1 C27H33N3O7
verruculogen
—— Desoxycarbadox-D3 1448350-02-4 C11H10N4O2
Desoxycarbadox-D3
—— Ciclesonide 22S-Epimer 141845-81-0 C32H44O7
Ciclesonide 22S-Epimer
—— 4,4'-Bipyridinium, 1,1'-dimethyl-, dichloride, hydrate 1083299-87-9 C12H16Cl2N2O
4,4'-Bipyridinium, 1,1'-dimethyl-, dichloride, hydrate
—— (S)-1-((2R,3R)-3-Hexyl-4-oxooxetan-2-yl)tridecan-2-yl formyl-L-leucinate 111466-62-7 C29H53NO5
(S)-1-((2R,3R)-3-Hexyl-4-oxooxetan-2-yl)tridecan-2-yl formyl-L-leucinate
—— 7D6KJ7YT6X 1338549-02-2 C22H28O4
7D6KJ7YT6X
—— (1R,3R,7E,22E,24R)-24-methyl-19-nor-9,10-secocholesta-5,7,22-triene-1,3,25-triol 132015-95-3 C27H44O3
(1R,3R,7E,22E,24R)-24-methyl-19-nor-9,10-secocholesta-5,7,22-triene-1,3,25-triol
—— Neodigoxin 55576-67-5 C41H64O14
Neodigoxin
—— 161861-18-3 C44H67NO12
—— Aloin-acetat 13928-72-8 C35H36O16
Aloin-acetat
—— 686773-61-5 C44H69NO12
—— 161861-10-5 C45H71NO13
—— 20-Carboxymethylprednisolone 229019-44-7 C21H28O4
20-Carboxymethylprednisolone
—— Sudan II-d6 1014689-15-6 C18H16N2O
Sudan II-d6
—— D-Glucopyranoside, decyl 54549-25-6 C16H32O6
D-Glucopyranoside, decyl
—— Sudan IV-d6 1014689-18-9 C24H20N4O
Sudan IV-d6
—— 9-fluoro-11β-hydroxy-16α,17-isopropylidenedioxy-pregn-4-ene-3,20-dione 3093-36-5 C24H33FO5
9-fluoro-11β-hydroxy-16α,17-isopropylidenedioxy-pregn-4-ene-3,20-dione
—— Bromochlorobuterol hydrochloride 78982-84-0 C12H19BrCl2N2O
Bromochlorobuterol hydrochloride
—— Cobalamin-monocarboxylic acid 26264-28-8 C63H87CoN13O15P
Cobalamin-monocarboxylic acid
—— (Z)-N-methyl-2-[2-(2,5-dimethylphenoxymethyl)phenyl]-2-methoxyiminoacetamide 145451-07-6 C19H22N2O3
(Z)-N-methyl-2-[2-(2,5-dimethylphenoxymethyl)phenyl]-2-methoxyiminoacetamide
—— [2-hydroxy-3-[(2R,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxypropyl] (E)-3-(4-hydroxyphenyl)prop-2-enoate 91853-77-9 C18H24O10
[2-hydroxy-3-[(2R,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxypropyl] (E)-3-(4-hydroxyphenyl)prop-2-enoate
—— trans-10,11-dibromo-10,11-dihydro-5H-dibenz<b,f>azepine-5-carbonyl chloride 40421-03-2 C15H10Br2ClNO
trans-10,11-dibromo-10,11-dihydro-5H-dibenz<b,f>azepine-5-carbonyl chloride
—— 88416-50-6 CH6Cl2NaO7P2
—— 2-[2-(4-Benzhydrylpiperazin-1-yl)ethoxy]acetic acid;hydrochloride 83881-54-3 C21H27ClN2O3
2-[2-(4-Benzhydrylpiperazin-1-yl)ethoxy]acetic acid;hydrochloride
—— 4-[hydroxy-(4-hydroxyphenyl)hydrazinylidene]cyclohexa-2,5-dien-1-one 15596-57-3 C12H10N2O3
4-[hydroxy-(4-hydroxyphenyl)hydrazinylidene]cyclohexa-2,5-dien-1-one
—— 1369773-39-6 C24H29CaNO5
—— Ponceau SX 4548-53-2 C18H16N2NaO7S2
Ponceau SX
—— 2-[3-(8-Azabicyclo[3.2.1]octan-3-yl)phenyl]-2-hydroxy-2-phenylacetic acid hydrochloride 63516-30-3 C21H24ClNO3
2-[3-(8-Azabicyclo[3.2.1]octan-3-yl)phenyl]-2-hydroxy-2-phenylacetic acid hydrochloride
—— profoxydim-lithium 281664-76-4 C24H31ClNO4S*Li
profoxydim-lithium
—— ethyl 2-[2-(4-methoxyphenyl)hydrazinylidene]propanoate 4792-57-8 C12H16N2O3
ethyl 2-[2-(4-methoxyphenyl)hydrazinylidene]propanoate
—— bi[(2S,4S)-2-dimethylaminocarbonyl-1-PNZ-pyrrolindin-4-yl]disulfide 936226-36-7 C30H36N6O10S2
bi[(2S,4S)-2-dimethylaminocarbonyl-1-PNZ-pyrrolindin-4-yl]disulfide
—— 1,6,7,8,9,10-Hexahydro-6,10-methano-2H-pyrazino(2,3-H)(3)benzazepin-2-one 357424-21-6 C13H13N3O
1,6,7,8,9,10-Hexahydro-6,10-methano-2H-pyrazino(2,3-H)(3)benzazepin-2-one
—— Unii-2dht4209JN 76812-64-1 C25H26ClNO6
Unii-2dht4209JN
—— Acetic acid, ((4-((3-ethynylphenyl)amino)-6-(2-methoxyethoxy)-7-quinazolinyl)oxy)- 882172-60-3 C21H19N3O5
Acetic acid, ((4-((3-ethynylphenyl)amino)-6-(2-methoxyethoxy)-7-quinazolinyl)oxy)-
—— Immunomycin;FR-900520;FK520 104987-12-4 C43H69NO12
Immunomycin;FR-900520;FK520
—— 4-amino-1-(tri-<i>O</i>-acetyl-β-<i>D</i>-arabinofuranosyl)-1<i>H</i>-[1,3,5]triazin-2-one 10302-78-0 C14H18N4O8
4-amino-1-(tri-<i>O</i>-acetyl-β-<i>D</i>-arabinofuranosyl)-1<i>H</i>-[1,3,5]triazin-2-one
—— (S)-Methoxy Cefoxitin 2395025-37-1 C17H19N3O8S2
(S)-Methoxy Cefoxitin
—— (6R,7S)-3-[[(Aminocarbonyl)oxy]methyl]-7-methoxy-7-[[(2R)-2-methoxy-2-(2-thienyl)acetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid 2395025-32-6 C17H19N3O8S2
(6R,7S)-3-[[(Aminocarbonyl)oxy]methyl]-7-methoxy-7-[[(2R)-2-methoxy-2-(2-thienyl)acetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
—— ethyl (S)-9-fluoro-3,7-dihydro-3-methyl-10-(1-aminocyclopropyl)-7-oxo-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylate 127046-18-8 C18H19FN2O4
ethyl (S)-9-fluoro-3,7-dihydro-3-methyl-10-(1-aminocyclopropyl)-7-oxo-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylate
—— 1-O-Acetyl-2,3,5-tri-O-benzoyl-α-D-lyxofuranose 3080-30-6 C28H24O9
1-O-Acetyl-2,3,5-tri-O-benzoyl-α-D-lyxofuranose
—— 6-methyl-5-azacytidine 105330-94-7 C9H14N4O5
6-methyl-5-azacytidine
—— N-Demethyl Roxithromycin 118267-18-8 C40H74N2O15
N-Demethyl Roxithromycin
—— ticarcillin 74682-62-5 C15H15N2O6S2*Na
ticarcillin
—— Edgeworoside C 126221-40-7 C24H20O10
Edgeworoside C