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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
(+)-新烟碱盐酸盐 anabasine hydrochloride 53912-89-3 C10H14N2*ClH
(+)-新烟碱盐酸盐
(+)-异薄荷醇 (+)-(1S,2R,5R)-isomenthol 23283-97-8 C10H20O
(+)-异薄荷醇
(+)-对-薄荷-1-烯 (+)-p-menth-1-ene 1195-31-9 C10H18
(+)-对-薄荷-1-烯
(+)-5-氨基-3-(S)-异丁基戊二酸 (S)-3-(carbamoylmethyl)-5-methylhexanoic acid 181289-34-9 C9H17NO3
(+)-5-氨基-3-(S)-异丁基戊二酸
(+)-2-乙氧基-4-(N-3-甲基-1(S)-(2-(1-哌啶基)苯基)-丁基)羰基甲基) (S)-(+)-ethyl 2-ethoxy-4-<2-<<3-methyl-1-<2-(1-piperidinyl)phenyl>butyl>amino>-2-oxoethyl>-benzoate 147770-06-7 C29H40N2O4
(+)-2-乙氧基-4-(N-3-甲基-1(S)-(2-(1-哌啶基)苯基)-丁基)羰基甲基)
(+)-(2S,3S)-2-(3-氯苯基)-3,5,5-三甲基吗啉-2-醇 (S,S)-hydroxybupropion hydrochloride 106083-71-0 C13H18ClNO2*ClH
(+)-(2S,3S)-2-(3-氯苯基)-3,5,5-三甲基吗啉-2-醇
(+)-(14beta)-二氢长春西丁 3α-deoxyepivincaminic acid ethyl ester 57517-54-1 C22H28N2O2
(+)-(14beta)-二氢长春西丁
((2S,3S,4S)-3-(苯甲酰氧基)-4-氟-4-甲基-5-氧代四氢呋喃-2-基)甲基苯甲酸甲酯 ((2S,3S,4S)-3-(benzoyloxy)-4-fluoro-4-methyl-5-oxotetrahydrofuran-2-yl)methyl benzoate 1946820-91-2 C20H17FO6
((2S,3S,4S)-3-(苯甲酰氧基)-4-氟-4-甲基-5-氧代四氢呋喃-2-基)甲基苯甲酸甲酯
—— Cytosin-arabinosid-3-N-oxid 30902-36-4 C9H13N3O6
Cytosin-arabinosid-3-N-oxid
—— 3-(2-cyano-4-pyridyl)-5-(1-oxy-4-pyridyl)-1,2,4-triazole 577778-82-6 C13H8N6O
3-(2-cyano-4-pyridyl)-5-(1-oxy-4-pyridyl)-1,2,4-triazole
—— Apovincinsaeureethylester 70155-05-4 C23H28N2O3
Apovincinsaeureethylester
—— 4-(1-Propenyl) Gemfibrozil 500904-61-0 C18H26O3
4-(1-Propenyl) Gemfibrozil
—— N-Nitrosonortriptyline 55855-42-0 C19H20N2O
N-Nitrosonortriptyline
—— ethyl (5Z,8Z,11Z,14Z,17E)-icosa-5,8,11,14,17-pentaenoate 73310-10-8 C22H34O2
ethyl (5Z,8Z,11Z,14Z,17E)-icosa-5,8,11,14,17-pentaenoate
—— (6S,9R,10S,13S,16R)-6,9-Difluoro-10,13,16-trimethyl-6,7,8,9,10,12,13,14,15,16-decahydro-cyclopenta[a]phenanthrene-3,11,17-trione 25256-98-8 C20H22F2O3
(6S,9R,10S,13S,16R)-6,9-Difluoro-10,13,16-trimethyl-6,7,8,9,10,12,13,14,15,16-decahydro-cyclopenta[a]phenanthrene-3,11,17-trione
—— N-[(2S)-2-amino-4-phenylbutanoyl]-L-leucine 290298-02-1 C16H24N2O3
N-[(2S)-2-amino-4-phenylbutanoyl]-L-leucine
—— 3-(3,5-dichloro-4-methoxybenzoyl)-1,2-dihydro-3H-1,3-benzothiazole 1285573-42-3 C15H11Cl2NO2S
3-(3,5-dichloro-4-methoxybenzoyl)-1,2-dihydro-3H-1,3-benzothiazole
—— 3-(3,5-dichloro-4-methoxybenzoyl)-1,1-dioxo-1,2-dihydro-3H-1,3-benzothiazole 1285573-44-5 C15H11Cl2NO4S
3-(3,5-dichloro-4-methoxybenzoyl)-1,1-dioxo-1,2-dihydro-3H-1,3-benzothiazole
—— 96-47-9 C5H10O
—— 1,3-di(biphenyl-2-yl)urea 115293-14-6 C25H20N2O
1,3-di(biphenyl-2-yl)urea
—— (Z)-3-(m-Cyanobenzyliden)phthalid 42086-68-0 C16H9NO2
(Z)-3-(m-Cyanobenzyliden)phthalid
—— (4aR,10R,10aS,11R)-6-Methoxy-11-methyl-11-oxo-1,3,4,9,10,10a-hexahydro-2H-10,4a-(epiminoethano)phenanthrene--hydrogen chloride (1/1) 1177494-18-6 C18H26ClNO2
(4aR,10R,10aS,11R)-6-Methoxy-11-methyl-11-oxo-1,3,4,9,10,10a-hexahydro-2H-10,4a-(epiminoethano)phenanthrene--hydrogen chloride (1/1)
—— 3-Oxocitalopram oxalate 1440961-11-4 C22H21FN2O6
3-Oxocitalopram oxalate
—— [2-(11,17-dihydroxy-6,10,13-trimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl] acetate 1625-11-2 C24H34O6
[2-(11,17-dihydroxy-6,10,13-trimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl] acetate
—— DIACETOXYSCIRPENOL 2270-40-8 C19H26O7
DIACETOXYSCIRPENOL
—— Chlordene 3734-48-3 C10H6Cl6
Chlordene
—— (6R,7S)-7-({(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-[(carboxymethoxy)imino]acetyl}amino)-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid 108691-83-4 C16H15N5O7S2
(6R,7S)-7-({(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-[(carboxymethoxy)imino]acetyl}amino)-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
—— 2-{6-[3(R)-amino-piperidin-1-yl]-3-(2-cyano-benzyl)-2,4-dioxo-3,4-dihydro-2H-pyrimidin-1-ylmethyl}-benzonitrile 865759-10-0 C25H24N6O2
2-{6-[3(R)-amino-piperidin-1-yl]-3-(2-cyano-benzyl)-2,4-dioxo-3,4-dihydro-2H-pyrimidin-1-ylmethyl}-benzonitrile
—— 11β,16α,17,21-tetrahydroxy-pregn-4-ene-3,20-dione 1171-81-9 C21H30O6
11β,16α,17,21-tetrahydroxy-pregn-4-ene-3,20-dione
—— 2-(4-Bromo-3-formylphenoxy)benzonitrile 1160182-46-6 C14H8BrNO2
2-(4-Bromo-3-formylphenoxy)benzonitrile
—— Ethyl linoleate; ethyl linolenate; ethyl oleate; ethyl palmitate; ethyl stearate 8001-25-0 C98H184O10
Ethyl linoleate; ethyl linolenate; ethyl oleate; ethyl palmitate; ethyl stearate
—— 7,8-epoxy-vitamin d3 89231-90-3 C27H44O2
7,8-epoxy-vitamin d3
—— 5-Chloro-1-{1-oxo-1-[3-(2-oxo-2,3,3a,7a-tetrahydro-1H-benzimidazol-1-yl)propyl]-1lambda~5~-piperidin-4-yl}-1,3,3a,7a-tetrahydro-2H-benzimidazol-2-one 118435-03-3 C22H28ClN5O3
5-Chloro-1-{1-oxo-1-[3-(2-oxo-2,3,3a,7a-tetrahydro-1H-benzimidazol-1-yl)propyl]-1lambda~5~-piperidin-4-yl}-1,3,3a,7a-tetrahydro-2H-benzimidazol-2-one
—— pregna-4,7-diene-3,20-dione 16484-70-1 C21H28O2
pregna-4,7-diene-3,20-dione
—— Unii-B3lwk12L14 832720-51-1 C31H28F5N3O5
Unii-B3lwk12L14
—— Cinchonan-9-ol, 6'-methoxy-, (8alpha,9R)-, sulfate (1:1) 549-56-4 C20H42N2O17S2
Cinchonan-9-ol, 6'-methoxy-, (8alpha,9R)-, sulfate (1:1)
—— 2-Chloro-4-(4-fluoro-phenyl)-5,6,7,8,9,10-hexahydro-cycloocta[b]pyridine 1-oxide 143213-96-1 C17H17ClFNO
2-Chloro-4-(4-fluoro-phenyl)-5,6,7,8,9,10-hexahydro-cycloocta[b]pyridine 1-oxide
—— tiamulone 113323-39-0 C28H45NO4S
tiamulone
—— Desmethyl-8-bromo Dragonfly Hydrochloride 178557-21-6 C12H15BrClNO2
Desmethyl-8-bromo Dragonfly Hydrochloride
—— 92134-98-0 C16H15N2NaO6P
—— (4R,4aS,5aS,6S,12aR)-4-(dimethylamino)-1,6,10,11,12a-pentahydroxy-3,12-dioxo-4a,5,5a,6-tetrahydro-4H-tetracene-2-carboxamide 129044-45-7 C21H22N2O8
(4R,4aS,5aS,6S,12aR)-4-(dimethylamino)-1,6,10,11,12a-pentahydroxy-3,12-dioxo-4a,5,5a,6-tetrahydro-4H-tetracene-2-carboxamide
—— 3-nitro-5,6,7,8-tetrahydroimidazo[1,2-a]pyridin-6-ol 1100750-18-2 C7H9N3O3
3-nitro-5,6,7,8-tetrahydroimidazo[1,2-a]pyridin-6-ol
—— Ethanone, 2,2'-(methylimino)bis[1-(3,4-dihydroxyphenyl)- 1188265-23-7 C17H17NO6
Ethanone, 2,2'-(methylimino)bis[1-(3,4-dihydroxyphenyl)-
—— Dimethachlor Metabolite CGA 373464 1196157-87-5 C12H15NNaO6S-
Dimethachlor Metabolite CGA 373464
—— 2-(3,4-dihydro-7-methoxy-1(2H)-naphthalenylidene)ethanamine 468104-18-9 C13H17NO
2-(3,4-dihydro-7-methoxy-1(2H)-naphthalenylidene)ethanamine
—— Cefadroxil dimer 2378158-45-1 C32H32N6O9S2
Cefadroxil dimer
—— 11β,17α-dihydroxy-3,20-dioxo-1,4-pregnadien-21-oic acid 61549-70-0 C21H26O6
11β,17α-dihydroxy-3,20-dioxo-1,4-pregnadien-21-oic acid
—— Linagliptin metabolite m489(1) 1807608-59-8 C25H28N8O3
Linagliptin metabolite m489(1)
—— Cloxacillin penilloic acid 1642559-64-5 C18H20ClN3O4S
Cloxacillin penilloic acid
—— 2-NP-Sca 13C,15N2 957509-32-9 C8H8N4O3
2-NP-Sca 13C,15N2