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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-amino-2-chloroacrolein 221615-73-2 C3H4ClNO
3-amino-2-chloroacrolein
—— (1R,3R)-bis(tert-butyldimethylsilyloxy)-1,10-seco-ergosta-5(E),7(E),10(19),22(E)-tetraene 115540-28-8 C40H72O2Si2
(1R,3R)-bis(tert-butyldimethylsilyloxy)-1,10-seco-ergosta-5(E),7(E),10(19),22(E)-tetraene
—— 6-O-methyl-2',4"-O-bis(trimethylsilyl)erythromycin A 9-[O-(1-methoxy-1-methylethyl)oxime] 119699-81-9 C48H94N2O14Si2
6-O-methyl-2',4"-O-bis(trimethylsilyl)erythromycin A 9-[O-(1-methoxy-1-methylethyl)oxime]
—— 4,6-Methano-1,3,2-benzodioxaborole-2-methanamine, hexahydro-3a,8,8-trimethyl-|A-(2-methylpropyl)-, hydrochloride (1:1), (|AS,3aS,4S,6S,7aR)- 945606-99-5 C15H28BNO2*ClH
4,6-Methano-1,3,2-benzodioxaborole-2-methanamine, hexahydro-3a,8,8-trimethyl-|A-(2-methylpropyl)-, hydrochloride (1:1), (|AS,3aS,4S,6S,7aR)-
—— trans-3-Aethyliden-2-oxo-pyrrolidin 930-94-9 C6H9NO
trans-3-Aethyliden-2-oxo-pyrrolidin
—— 5-chloro-3-(4-methylthiophenyl)-6'-methyl-[2,3']bipyridine hydrochloride 1447814-82-5 C18H15ClN2S*ClH
5-chloro-3-(4-methylthiophenyl)-6'-methyl-[2,3']bipyridine hydrochloride
—— 73836-78-9 C25H40N2O6S
—— 6-O-methylerythromycin A 9-oxime 103450-87-9 C38H70N2O13
6-O-methylerythromycin A 9-oxime
—— NEOSPIRAMYCIN I STANDARD 70253-62-2 C36H62N2O11
NEOSPIRAMYCIN I STANDARD
—— (3R,4S,5S,6R,7R,9R,10E,11S,12R,13S,14R)-6-[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-14-ethyl-12,13-dihydroxy-10-hydroxyimino-4-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-7-methoxy-3,5,7,9,11,13-hexamethyl-oxacyclot 103450-87-9 C38H70N2O13
(3R,4S,5S,6R,7R,9R,10E,11S,12R,13S,14R)-6-[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-14-ethyl-12,13-dihydroxy-10-hydroxyimino-4-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-7-methoxy-3,5,7,9,11,13-hexamethyl-oxacyclot
—— Acx53N3fxt 165115-78-6 C19H20F2O2
Acx53N3fxt
—— 4-dimethylamino-3-(6-imidazo<1,2-a>pyridinyl)-3-buten-2-one 106730-70-5 C13H15N3O
4-dimethylamino-3-(6-imidazo<1,2-a>pyridinyl)-3-buten-2-one
—— cis-nonachlor 5103-73-1 C10H5Cl9
cis-nonachlor
—— 24H,a26H-aBenzo[b]aporphine-a9,a13-adipropanoic acid, 18-aethenyl-a4,a4a-adihydro-a3,a4-abis(methoxycarbonyl)a-a4a,a8,a14,a19-atetramethyl-a, (4S,a4aR)a- 1024683-17-7 C40H40N4O8
24H,a26H-aBenzo[b]aporphine-a9,a13-adipropanoic acid, 18-aethenyl-a4,a4a-adihydro-a3,a4-abis(methoxycarbonyl)a-a4a,a8,a14,a19-atetramethyl-a, (4S,a4aR)a-
—— Digoxigenin Bisdigitoxoside 5297-05-2 C35H54O11
Digoxigenin Bisdigitoxoside
—— 4'-Deoxyleurocristine 68135-16-0 C46H56N4O9
4'-Deoxyleurocristine
—— 7-Hydroxy-lathyrol 34208-98-5 C20H30O5
7-Hydroxy-lathyrol
—— (S)-1-benzalimino-3-chloro-2-propanol 224323-52-8 C10H12ClNO
(S)-1-benzalimino-3-chloro-2-propanol
—— 54925-33-6 C9H12N3NaO7P
—— 21-acetoxy-11β-hydroxy-6α-methyl-pregna-1,4,17(20)<i>c</i>-trien-3-one 1968-76-9 C24H32O4
21-acetoxy-11β-hydroxy-6α-methyl-pregna-1,4,17(20)<i>c</i>-trien-3-one
—— [(2R,4S,5S,7R,10S,12S,13S,15S,16S)-2,10-diacetyloxy-15-[(2R,3S)-3-benzamido-2-hydroxy-3-phenylpropanoyl]oxy-5,13-dihydroxy-4,16,17,17-tetramethyl-3-oxo-8-oxapentacyclo[11.3.1.01,11.04,11.07,10]heptadecan-12-yl] benzoate 146139-03-9 C47H51NO14
[(2R,4S,5S,7R,10S,12S,13S,15S,16S)-2,10-diacetyloxy-15-[(2R,3S)-3-benzamido-2-hydroxy-3-phenylpropanoyl]oxy-5,13-dihydroxy-4,16,17,17-tetramethyl-3-oxo-8-oxapentacyclo[11.3.1.01,11.04,11.07,10]heptadecan-12-yl] benzoate
—— 2-(1,2-dihydro-6-methoxynaphthalen-4-yl)acetic acid 27533-69-3 C13H14O3
2-(1,2-dihydro-6-methoxynaphthalen-4-yl)acetic acid
—— Erythromycin A 6,9-Imino Ether 99290-97-8 C37H66N2O12
Erythromycin A 6,9-Imino Ether
—— (4S,4aS,5aR,12S)-4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-9-nitro-1,11-dioxanaphthacene-2-carboxamide 149934-16-7 C23H26N4O9
(4S,4aS,5aR,12S)-4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-9-nitro-1,11-dioxanaphthacene-2-carboxamide
—— N-(2-Bromaethyl)-p-fluoranilinhydrobromid 770-42-3 BrH*C8H9BrFN
N-(2-Bromaethyl)-p-fluoranilinhydrobromid
—— [(5S,8R,9S,10S,13S,14S,16S,17R)-10,13-dimethyl-2-morpholin-4-yl-3-oxo-16-(1-prop-2-enylpyrrolidin-1-ium-1-yl)-4,5,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-17-yl] acetate;bromide 1190105-67-9 C32H49BrN2O4
[(5S,8R,9S,10S,13S,14S,16S,17R)-10,13-dimethyl-2-morpholin-4-yl-3-oxo-16-(1-prop-2-enylpyrrolidin-1-ium-1-yl)-4,5,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-17-yl] acetate;bromide
—— Humalog 133107-64-9 C257H383N65O77S6
Humalog
—— N-Methylol Minocycline 1075240-33-3 C24H29N3O8
N-Methylol Minocycline
—— (-)-(6R,7R)-7-<(Z)-2-(2-amino-4-thiazolyl)-2-methoxyiminoacetamido>-3-<<<5-(carboxymethyl)-4-methyl-2-thiazolyl>thio>methyl>-8-oxo-5-thia-1-azabicyclo<4.2.0>oct-3-ene-2-carboxylic acid 120533-30-4 C20H20N6O7S4
(-)-(6R,7R)-7-<(Z)-2-(2-amino-4-thiazolyl)-2-methoxyiminoacetamido>-3-<<<5-(carboxymethyl)-4-methyl-2-thiazolyl>thio>methyl>-8-oxo-5-thia-1-azabicyclo<4.2.0>oct-3-ene-2-carboxylic acid
—— 21-acetoxy-11β,17-dihydroxy-6α-methyl-5α-pregnane-3,20-dione 114696-04-7 C24H36O6
21-acetoxy-11β,17-dihydroxy-6α-methyl-5α-pregnane-3,20-dione
—— 6β-((<i>R</i>)-2-{6β-[(<i>R</i>)-2-(4-ethyl-2,3-dioxo-piperazine-1-carbonylamino)-2-phenyl-acetylamino]-penicillanoylamino}-2-phenyl-acetylamino)-penicillanic acid 65772-67-0 C39H44N8O10S2
6β-((<i>R</i>)-2-{6β-[(<i>R</i>)-2-(4-ethyl-2,3-dioxo-piperazine-1-carbonylamino)-2-phenyl-acetylamino]-penicillanoylamino}-2-phenyl-acetylamino)-penicillanic acid
—— exo-3-Amino-9-methyl-9-azabicyclo[3,3,1]nonane 76272-41-8 C9H18N2
exo-3-Amino-9-methyl-9-azabicyclo[3,3,1]nonane
—— desacetylvincristine 3704-01-6 C44H54N4O9
desacetylvincristine
—— [[(1a,3b,5E,7E,22E)-9,10-Secoergosta-5,7,10(19),22-tetraene-1,3-diyl]bis(oxy)]bis[(1,1-dimethylethyl)dimethylsilane] 111594-58-2 C40H72O2Si2
[[(1a,3b,5E,7E,22E)-9,10-Secoergosta-5,7,10(19),22-tetraene-1,3-diyl]bis(oxy)]bis[(1,1-dimethylethyl)dimethylsilane]
—— 3,3-dimethoxy-17α-cyanomethyl-17β-hydroxy-estra-5(10),9(11)-diene 102193-41-9 C22H31NO3
3,3-dimethoxy-17α-cyanomethyl-17β-hydroxy-estra-5(10),9(11)-diene
—— (3aR,5R,6aS)-5-hydroxy-4-(hydroxymethyl)-3,3a,4,5,6,6a-hexahydrocyclopenta[b]furan-2-one 32233-40-2 C8H12O4
(3aR,5R,6aS)-5-hydroxy-4-(hydroxymethyl)-3,3a,4,5,6,6a-hexahydrocyclopenta[b]furan-2-one
—— methyl 2-((1S,2S,3S,4R)-4-(7-((1R,2S)-2-(3,4-difluorophenyl)-cyclopropylamino)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-2,3-dihydroxycyclopentyloxy)acetate 1402150-11-1 C24H28F2N6O5S
methyl 2-((1S,2S,3S,4R)-4-(7-((1R,2S)-2-(3,4-difluorophenyl)-cyclopropylamino)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-2,3-dihydroxycyclopentyloxy)acetate
—— 16β-methyl-11β,17α,21-trihydroxy-1,4-pregnadiene-3,20-dione 17,21-dipropionate 71934-47-9 C28H38O7
16β-methyl-11β,17α,21-trihydroxy-1,4-pregnadiene-3,20-dione 17,21-dipropionate
—— 17-cyclopropylmethyl-3,14β-dihydroxy-4,5α-epoxy-6β-[N-methyl-trans-3-(3-furyl)acrylamido]morphinan-N-oxide 208042-42-6 C28H32N2O6
17-cyclopropylmethyl-3,14β-dihydroxy-4,5α-epoxy-6β-[N-methyl-trans-3-(3-furyl)acrylamido]morphinan-N-oxide
—— ethyl α<(N,N-dimethylamino)methylene>-2,3,4,5-tetrafluoro-β-oxobenzenepropanoate 138998-47-7 C14H13F4NO3
ethyl α<(N,N-dimethylamino)methylene>-2,3,4,5-tetrafluoro-β-oxobenzenepropanoate
—— 5793-89-5 C6H10O8.Ca.4H2O
—— 89368-94-5 C46H55BrN4O8
—— 6-[4-[1-(4-hydroxycyclohexyl)tetrazol-5-yl]butoxy]-3,4-dihydro-1H-quinolin-2-one 87153-04-6 C20H27N5O3
6-[4-[1-(4-hydroxycyclohexyl)tetrazol-5-yl]butoxy]-3,4-dihydro-1H-quinolin-2-one
—— ENDRIN KETONE 7378-10-1 C12H8Cl6O
ENDRIN KETONE
—— 2,5-dichloro-N-[2-({(1R)-3-methyl-1-[(3aS,4S,6S,7aR)-3a,5,5-trimethylhexahydro-4,6-methano-1,3,2-benzod ioxaborol-2-yl]butyl}amino)-2-oxoethyl]benzamide 1201903-02-7 C24H33BCl2N2O4
2,5-dichloro-N-[2-({(1R)-3-methyl-1-[(3aS,4S,6S,7aR)-3a,5,5-trimethylhexahydro-4,6-methano-1,3,2-benzod ioxaborol-2-yl]butyl}amino)-2-oxoethyl]benzamide
—— ENDRIN KETONE 7378-10-1 C12H8Cl6O
ENDRIN KETONE
—— 4-(2-bromoacetyl)phenyl acetate 41104-10-3 C10H9BrO3
4-(2-bromoacetyl)phenyl acetate
—— 3-hydroxyphenyl-trimethyl-ammonium methyl-sulfate 4312-54-3 CH3O4S*C9H14NO
3-hydroxyphenyl-trimethyl-ammonium methyl-sulfate
—— 2,4,6,3',5'-pentamethoxybiphenyl 84212-55-5 C17H20O5
2,4,6,3',5'-pentamethoxybiphenyl
—— (1S,2R,3R,4S,5S,6R)-6-{[(2R,3R,4S,5S,6S)-3,4,5-Trihydroxy-6-methoxytetrahydro-2H-pyran-2-yl]oxy}-1,2,3,4,5-cyclohexanepentol 2347-99-1 C12H22O11
(1S,2R,3R,4S,5S,6R)-6-{[(2R,3R,4S,5S,6S)-3,4,5-Trihydroxy-6-methoxytetrahydro-2H-pyran-2-yl]oxy}-1,2,3,4,5-cyclohexanepentol