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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
—— 17α,21-Dihydroxy-9β,11β-epoxy-16β-methyl-pregnadien-(1.4)-dion-(3.20) 981-34-0 C22H28O5
17α,21-Dihydroxy-9β,11β-epoxy-16β-methyl-pregnadien-(1.4)-dion-(3.20)
—— N-<4-(methylamino)benzoyl>-L-glutamic acid γ-methyl ester 79974-19-9 C14H18N2O5
N-<4-(methylamino)benzoyl>-L-glutamic acid γ-methyl ester
—— 4-(4-(3-(4-Chloro-3-(trifluoromethyl)phenyl)ureido)-3-(4-(3-(4-chloro-3-(trifluoromethyl)phenyl)ureido)-3-fluorophenoxy)phenoxy)-N-methylpicolinamide 2098799-13-2 C35H23Cl2F7N6O5
4-(4-(3-(4-Chloro-3-(trifluoromethyl)phenyl)ureido)-3-(4-(3-(4-chloro-3-(trifluoromethyl)phenyl)ureido)-3-fluorophenoxy)phenoxy)-N-methylpicolinamide
—— (1R,3S,10S)-1,2,2,3,10,11-hexachloropentacyclo[5.4.1.03,10.04,12.05,9]dodecan-8-one 53494-70-5 C12H8Cl6O
(1R,3S,10S)-1,2,2,3,10,11-hexachloropentacyclo[5.4.1.03,10.04,12.05,9]dodecan-8-one
—— 17α-Acetoxyoestradiol 1743-60-8 C20H26O3
17α-Acetoxyoestradiol
—— Ponceau RN 3564-09-8 C19H18N2NaO7S2+
Ponceau RN
—— (9E)-2'-O-[(2-Methoxyethoxy)methyl] Erythromycin 9-[O-[(2-Methoxyethoxy)methyl] oxime] 425365-66-8 C45H84N2O17
(9E)-2'-O-[(2-Methoxyethoxy)methyl] Erythromycin 9-[O-[(2-Methoxyethoxy)methyl] oxime]
—— Tadalafil-methyl-d3 960226-55-5 C22H19N3O4
Tadalafil-methyl-d3
—— levulinic acid ; calcium compound 5743-49-7 2C5H7O3*Ca*2H2O
levulinic acid ; calcium compound
—— N-(3-chloro-4-fluorophenyl)-7-ethoxy-6-nitroquinazolin-4-amine 1360430-70-1 C16H12ClFN4O3
N-(3-chloro-4-fluorophenyl)-7-ethoxy-6-nitroquinazolin-4-amine
—— calcium D-saccharate tetrahydrate 5793-89-5 C6H8O8*Ca*4H2O
calcium D-saccharate tetrahydrate
—— 3-<Biphenylyl-(4)>-2-cyan-acrylsaeure 63472-31-1 C16H11NO2
3-<Biphenylyl-(4)>-2-cyan-acrylsaeure
—— galloflavin 568-80-9 C12H6O8
galloflavin
—— (1,6-dimethyl-ergolin-8β-yl)-methanol 40170-12-5 C17H22N2O
(1,6-dimethyl-ergolin-8β-yl)-methanol
—— N-(1-phenylethyl)-1-azabicyclo[2.2.2]octan-3-amine;dihydrochloride 120570-09-4 C15H24Cl2N2
N-(1-phenylethyl)-1-azabicyclo[2.2.2]octan-3-amine;dihydrochloride
—— 2-NP-Aoz D4 1007478-57-0 C10H9N3O4
2-NP-Aoz D4
—— Sodium;9-[(E)-4-[(2S,3aS,6S,7S,7aR)-2-[(2S,3S)-1,3-dihydroxy-2-methylbutyl]-7-hydroxy-3,3a,4,6,7,7a-hexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyl]oxynonanoate 116182-43-5 C26H43NaO9
Sodium;9-[(E)-4-[(2S,3aS,6S,7S,7aR)-2-[(2S,3S)-1,3-dihydroxy-2-methylbutyl]-7-hydroxy-3,3a,4,6,7,7a-hexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyl]oxynonanoate
—— 2-[(1S)-1-chloro-3-methylbutyl]-(3aS,4S,6S,7aR)-hexahydro-3a,5,5-trimethyl-4,6-methano-1,3,2-benzodioxaborole 87304-47-0 C15H26BClO2
2-[(1S)-1-chloro-3-methylbutyl]-(3aS,4S,6S,7aR)-hexahydro-3a,5,5-trimethyl-4,6-methano-1,3,2-benzodioxaborole
—— 1-[2-(2-methoxyphenoxy)ethylamino]-3-(6,7,8,9-tetrahydro-5H-carbazol-4-yloxy)propan-2-ol 1246820-73-4 C48H60N4O8
1-[2-(2-methoxyphenoxy)ethylamino]-3-(6,7,8,9-tetrahydro-5H-carbazol-4-yloxy)propan-2-ol
—— 5-(Hydroxymethyl)-3-{[(5-nitrofuran-2-yl)methylidene]amino}-1,3-oxazolidin-2-one 41359-15-3 C9H9N3O6
5-(Hydroxymethyl)-3-{[(5-nitrofuran-2-yl)methylidene]amino}-1,3-oxazolidin-2-one
—— 2-[(8R,9S,10R,13S,14S)-17-hydroxy-13-methyl-3-oxo-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-yl]acetonitrile 67473-36-3 C20H27NO2
2-[(8R,9S,10R,13S,14S)-17-hydroxy-13-methyl-3-oxo-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-yl]acetonitrile
—— cis-Zearalenol 5916-52-9 C18H24O5
cis-Zearalenol
—— Yohimban-16-carboxylic acid, 11,17-dimethoxy-18-[[3,4,5-tri(methoxy-d3)benzoyl]oxy]-, methyl ester, (3ss,16ss,17a,18ss,20a)-(9CI); Benz[g]indolo[2,3-a]quinolizine, yohimban-16-carboxylic acid deriv. 84759-11-5 C33H40N2O9
Yohimban-16-carboxylic acid, 11,17-dimethoxy-18-[[3,4,5-tri(methoxy-d3)benzoyl]oxy]-, methyl ester, (3ss,16ss,17a,18ss,20a)-(9CI); Benz[g]indolo[2,3-a]quinolizine, yohimban-16-carboxylic acid deriv.
—— [(1S,3E,5R)-3-[2-[(1R,3aS,7aR)-1-[(E,2R,5R)-5,6-dimethylhept-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-5-[tert-butyl(dimethyl)silyl]oxy-2-methylidenecyclohexyl]oxy-tert-butyl-dimethylsilane 111594-58-2 C40H72O2Si2
[(1S,3E,5R)-3-[2-[(1R,3aS,7aR)-1-[(E,2R,5R)-5,6-dimethylhept-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-5-[tert-butyl(dimethyl)silyl]oxy-2-methylidenecyclohexyl]oxy-tert-butyl-dimethylsilane
—— 1-[(2R,4R)-4-Benzyloxymethyl-2-(2,4-difluoro-phenyl)-tetrahydro-furan-2-ylmethyl]-1H-[1,2,4]triazole 165115-83-3 C21H21F2N3O2
1-[(2R,4R)-4-Benzyloxymethyl-2-(2,4-difluoro-phenyl)-tetrahydro-furan-2-ylmethyl]-1H-[1,2,4]triazole
—— Fumonisin B2-13C34 1217481-36-1 C34H59NO14
Fumonisin B2-13C34
—— (3R,8S,9S,12R)-Atazanavir 1292296-11-7 C38H52N6O7
(3R,8S,9S,12R)-Atazanavir
—— 6-O-Methylerythromycin A (E)-9-(O-methyloxime); (9E)-6-O-Methylerythromycin 9-(O-methyloxime); Oxacyclotetradecane, erythromycin deriv.; Clarithromycin Imp. G (EP) 127182-44-9 C39H72N2O13
6-O-Methylerythromycin A (E)-9-(O-methyloxime); (9E)-6-O-Methylerythromycin 9-(O-methyloxime); Oxacyclotetradecane, erythromycin deriv.; Clarithromycin Imp. G (EP)
—— monosultap 29547-00-0 C5H12NO6S4*Na
monosultap
—— Pubchem_71315344 80621-76-7 C43H49N3O11
Pubchem_71315344
—— (~237~Np)Neptunium--water (1/2) 58670-16-9 H4NpO2
(~237~Np)Neptunium--water (1/2)
—— delta 7-methylnaltrexone bromide 1027638-96-5 Br*C21H24NO4
delta 7-methylnaltrexone bromide
—— (8S,9S,10R,11S,13S,14S,16R,17S)-11,16,17-trihydroxy-10,13-dimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthrene-17-carboxylic acid 1185143-75-2 C20H26O6
(8S,9S,10R,11S,13S,14S,16R,17S)-11,16,17-trihydroxy-10,13-dimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthrene-17-carboxylic acid
—— (1S,2S)-2-(Aminomethyl)-N,N-diethyl-1-phenyl-cyclopropanecarboxamide hydrochloride 101152-94-7 C15H23ClN2O
(1S,2S)-2-(Aminomethyl)-N,N-diethyl-1-phenyl-cyclopropanecarboxamide hydrochloride
—— 2-ethoxy-6-nitro-9-phenoxy-acridine 20304-71-6 C21H16N2O4
2-ethoxy-6-nitro-9-phenoxy-acridine
—— O-1,3-Benzothiazol-2-yl (2Z)-(2-amino-1,3-thiazol-4-yl)(methoxyimino)ethanethioate 959246-33-4 C13H10N4O2S3
O-1,3-Benzothiazol-2-yl (2Z)-(2-amino-1,3-thiazol-4-yl)(methoxyimino)ethanethioate
—— (6R,7R)-3-[(Carbamoyloxy)methyl]-7-{[(2Z)-2-(furan-2-yl)-2-(methoxyimino)acetyl]amino}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-3-ene-2-carboxylic acid 229499-08-5 C16H16N4O8S
(6R,7R)-3-[(Carbamoyloxy)methyl]-7-{[(2Z)-2-(furan-2-yl)-2-(methoxyimino)acetyl]amino}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-3-ene-2-carboxylic acid
—— N-[6-[6-[(10'Z,14'Z)-21',24'-dihydroxy-3,11',13',22'-tetramethyl-2'-oxo-2-propan-2-ylspiro[2,3-dihydropyran-6,6'-3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene]-12'-yl]oxy-4-methoxy-2-methyloxan-3-yl]oxy-4-methoxy-2-methyloxan-3-yl]acetamide 123997-26-2 C49H73NO14
N-[6-[6-[(10'Z,14'Z)-21',24'-dihydroxy-3,11',13',22'-tetramethyl-2'-oxo-2-propan-2-ylspiro[2,3-dihydropyran-6,6'-3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene]-12'-yl]oxy-4-methoxy-2-methyloxan-3-yl]oxy-4-methoxy-2-methyloxan-3-yl]acetamide
—— (trans-4-Hydroxycyclohexyl)-(2-aminobenzyl)-amin 46727-91-7 C13H20N2O
(trans-4-Hydroxycyclohexyl)-(2-aminobenzyl)-amin
—— 21-lauroyl dexamethasone 149793-68-0 C34H51FO6
21-lauroyl dexamethasone
—— ethyl 3-ethoxy-2-(2,3,4,5-tetrafluorobenzoyl)acrylate 94714-58-6 C14H12F4O4
ethyl 3-ethoxy-2-(2,3,4,5-tetrafluorobenzoyl)acrylate
—— (3R)-N-[(1S)-1-Phenylethyl]quinuclidin-3-amine dihydrochloride 120570-09-4 C15H22N2*2ClH
(3R)-N-[(1S)-1-Phenylethyl]quinuclidin-3-amine dihydrochloride
—— (+/-)-pleuromutilin 125-65-5 C22H34O5
(+/-)-pleuromutilin
—— Trifolin 31049-08-8 C21H22O11
Trifolin
—— (6S,8S,9S,10R,11S,13S,14S,17S)-11-Hydroxy-17-(2-hydroxy-acetyl)-6,10,13-trimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-cyclopenta[a]phenanthren-3-one 103744-18-9 C22H30O4
(6S,8S,9S,10R,11S,13S,14S,17S)-11-Hydroxy-17-(2-hydroxy-acetyl)-6,10,13-trimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-cyclopenta[a]phenanthren-3-one
—— (3E)-2-(2,2-diphenylacetyl)-3-[(Z)-propylidenehydrazinylidene]inden-1-one 1119449-20-5 C26H22N2O2
(3E)-2-(2,2-diphenylacetyl)-3-[(Z)-propylidenehydrazinylidene]inden-1-one
—— benzyl 3-aminosulfonyl-5-butylamino-4-phenoxybenzoate 885051-29-6 C24H26N2O5S
benzyl 3-aminosulfonyl-5-butylamino-4-phenoxybenzoate
—— (Z)-3'-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1H-pyrazol-4(5H)-ylidene)-hydrazinyl)-2'-hydroxybiphenyl-3-carboxamide 1246929-02-1 C25H23N5O3
(Z)-3'-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1H-pyrazol-4(5H)-ylidene)-hydrazinyl)-2'-hydroxybiphenyl-3-carboxamide
—— (E)-N-[4,5α-epoxy-3,14β-dihydroxymorphinan-6β-yl]-3-(furan-3-yl)-N-methylprop-2-enamide 163713-06-2 C24H26N2O5
(E)-N-[4,5α-epoxy-3,14β-dihydroxymorphinan-6β-yl]-3-(furan-3-yl)-N-methylprop-2-enamide
—— 5a,8b-dimethyloctahydro-2a,5,6,8a-tetraazaacenaphthylene 214195-92-3 C10H20N4
5a,8b-dimethyloctahydro-2a,5,6,8a-tetraazaacenaphthylene