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    首页 分子通 按物质功能分类 分析化学 标准品 药典标准品和杂质标准品

    药典标准品和杂质标准品

    药典标准品是指由国家药品监督管理局认定并公布的、用于药物质量控制的标准物质，其纯度、含量及稳定性等特性已经过严格验证。药典标准品在确保药品质量和安全性方面起着至关重要的作用。

    杂质标准品则是指用于检测药物中可能存在的各种类型杂质的化学试剂或混合物。与药典标准品不同的是，杂质标准品不一定是单一化合物的标准品，它们可以是特定类型的杂质或是代表性的杂质混合物，旨在帮助制药企业进行质量控制和开发更为严格的生产工艺。

    两者在药品生产和监管中都发挥着重要作用：药典标准品用于检测药物的主要成分是否符合规定的含量范围；而杂质标准品则有助于识别、定量分析并降低潜在的有害杂质，从而确保最终产品的安全性和有效性。在研发新药或改进现有药物的过程中，正确使用这些标准品可以有效提高产品质量和安全性评估水平。

    中文名称 英文名称 CAS号 化学式 结构式图片
    —— didemnin B 77327-05-0 C57H89N7O15
    didemnin B
    —— (5E,9E,13Z)-6,10,14,18-tetramethyl-5,9,13,17-nonadecatetraen-2-one 3879-23-0 C23H38O
    (5E,9E,13Z)-6,10,14,18-tetramethyl-5,9,13,17-nonadecatetraen-2-one
    —— calcium D-glucarate 5793-88-4 C6H8O8*Ca
    calcium D-glucarate
    —— 1-[(3R,5S,10S,13S,17S)-3-hydroxy-3,10,13-trimethyl-1,2,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydrocyclopenta[a]phenanthren-17-yl]ethanone 38398-32-2 C22H36O2
    1-[(3R,5S,10S,13S,17S)-3-hydroxy-3,10,13-trimethyl-1,2,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydrocyclopenta[a]phenanthren-17-yl]ethanone
    —— 2-Dodecyl-3-hydroxy-1,4-naphthoquinone 57960-31-3 C22H30O3
    2-Dodecyl-3-hydroxy-1,4-naphthoquinone
    —— Erythromycin B 527-75-3 C37H67NO12
    Erythromycin B
    —— 5-chlorofuran-2-carbonyl chloride 24078-79-3 C5H2Cl2O2
    5-chlorofuran-2-carbonyl chloride
    —— (+)-(L)-2-(N'-cyclohexylidenehydrazino)-3-(3,4-dihydroxyphenyl)-2-methyl propionic acid methyl ester 934371-48-9 C17H24N2O4
    (+)-(L)-2-(N'-cyclohexylidenehydrazino)-3-(3,4-dihydroxyphenyl)-2-methyl propionic acid methyl ester
    —— N<sup>1</sup>-methyl-N<sup>1</sup>-(4-amino-6,7-dimethoxy-2-quinazolinyl)-1,3-propanediamine hydrochloride 81403-69-2 C14H21N5O2*ClH
    N<sup>1</sup>-methyl-N<sup>1</sup>-(4-amino-6,7-dimethoxy-2-quinazolinyl)-1,3-propanediamine hydrochloride
    —— (2S,3S,5S)-2-hexyl-3,5-dihydroxyhexadecanoic acid 130793-30-5 C22H44O4
    (2S,3S,5S)-2-hexyl-3,5-dihydroxyhexadecanoic acid
    —— 4-(4-acetoxy-3-methoxybenzylidene)-2-phenyl-5-oxazolone 18692-68-7 C19H15NO5
    4-(4-acetoxy-3-methoxybenzylidene)-2-phenyl-5-oxazolone
    —— 4-amino-1-(2-deoxy-α-D-erythropentofuranosyl)-1,3,5-triazin-2(1H)-one 22432-95-7 C8H12N4O4
    4-amino-1-(2-deoxy-α-D-erythropentofuranosyl)-1,3,5-triazin-2(1H)-one
    —— 4-Ethoxy-3-(pyrid-4-yl)but-3-en-2-on 88349-61-5 C11H13NO2
    4-Ethoxy-3-(pyrid-4-yl)but-3-en-2-on
    —— 6-amino-1,5-dimethylpyrimidine-2,4-(1H,3H)-dione 63959-47-7 C6H9N3O2
    6-amino-1,5-dimethylpyrimidine-2,4-(1H,3H)-dione
    —— 2-methyl-4-(2-methylbenzoylamino)benzoyl chloride 331947-69-4 C16H14ClNO2
    2-methyl-4-(2-methylbenzoylamino)benzoyl chloride
    —— 4-amino-(2-methylphenyl)(7-chloro-5-hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]-azepin-1-yl)methanone 1432725-24-0 C18H19ClN2O2
    4-amino-(2-methylphenyl)(7-chloro-5-hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]-azepin-1-yl)methanone
    —— 2-[(1R)-3-(diisopropylamino)-1-phenylpropyl]-4-methylphenyl 2-methylpropanoate 895137-81-2 C26H37NO2
    2-[(1R)-3-(diisopropylamino)-1-phenylpropyl]-4-methylphenyl 2-methylpropanoate
    —— loperamide oxide 106900-12-3 C29H33ClN2O3
    loperamide oxide
    —— (Z)-11-(3-dimethylaminopropylidene)-6,11-dihydrodibenz[b,e] oxepin-2-acetic acid ethyl ester 113806-03-4 C23H27NO3
    (Z)-11-(3-dimethylaminopropylidene)-6,11-dihydrodibenz[b,e] oxepin-2-acetic acid ethyl ester
    —— (R)-α-(cyclopentyl-1-ene)-α-hydroxyl-α-phenylacetic acid 185030-09-5 C13H14O3
    (R)-α-(cyclopentyl-1-ene)-α-hydroxyl-α-phenylacetic acid
    —— desmethylazatadine 38092-95-4 C19H20N2
    desmethylazatadine
    —— 4-(E)-4-(dimethylamino)-1-(4-fluorophenyl)but-1-enyl-3-(hydroxymethyl)benzonitrile 1370643-23-4 C20H21FN2O
    4-(E)-4-(dimethylamino)-1-(4-fluorophenyl)but-1-enyl-3-(hydroxymethyl)benzonitrile
    —— tangshenoside I 117278-74-7 C29H42O18
    tangshenoside I
    —— N-chloroacetyl-L-proline methyl ester 38074-72-5 C8H12ClNO3
    N-chloroacetyl-L-proline methyl ester
    —— (6<i>R</i>)-7<i>t</i>-((<i>R</i>)-2-amino-2-cyclohex-1-enyl-acetylamino)-3-methyl-8-oxo-(6<i>r</i><i>H</i>)-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid 37051-00-6 C16H21N3O4S
    (6<i>R</i>)-7<i>t</i>-((<i>R</i>)-2-amino-2-cyclohex-1-enyl-acetylamino)-3-methyl-8-oxo-(6<i>r</i><i>H</i>)-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid
    —— (6<i>R</i>)-7<i>t</i>-(2-chloro-acetylamino)-3-methyl-8-oxo-(6<i>r</i><i>H</i>)-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid 40818-86-8 C10H11ClN2O4S
    (6<i>R</i>)-7<i>t</i>-(2-chloro-acetylamino)-3-methyl-8-oxo-(6<i>r</i><i>H</i>)-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid
    —— 3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)benzamide 917391-28-7 C12H10F3N3O
    3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)benzamide
    —— (2R,4S)-S-carboxymethylcysteine sulfoxide 112246-66-9 C5H9NO5S
    (2R,4S)-S-carboxymethylcysteine sulfoxide
    —— (R)-6-{(1R,3aS,7aR)-4-[2-[(S)-5-(tert-Butyl-dimethyl-silanyloxy)-2-methylene-cyclohex-(Z)-ylidene]-eth-(E)-ylidene]-7a-methyl-octahydro-inden-1-yl}-2-methyl-heptan-2-ol 140710-90-3 C33H58O2Si
    (R)-6-{(1R,3aS,7aR)-4-[2-[(S)-5-(tert-Butyl-dimethyl-silanyloxy)-2-methylene-cyclohex-(Z)-ylidene]-eth-(E)-ylidene]-7a-methyl-octahydro-inden-1-yl}-2-methyl-heptan-2-ol
    —— Tersigat 30286-75-0 Br*C19H26NO4
    Tersigat
    —— 4-[4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-1-oxobutyl]-α,α-dimethylbenzeneacetic acid hydrochloride 153439-43-1 C32H37NO4*ClH
    4-[4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-1-oxobutyl]-α,α-dimethylbenzeneacetic acid hydrochloride
    —— 6-perdeoxy-6-per-chloro gamma-cyclodextrin 173094-60-5 C48H72Cl8O32
    6-perdeoxy-6-per-chloro gamma-cyclodextrin
    —— ganciclovir dipropionate 86357-20-2 C15H21N5O6
    ganciclovir dipropionate
    —— vardenafil monohydrochloride trihydrate 330808-88-3 C23H32N6O4S*ClH*3H2O
    vardenafil monohydrochloride trihydrate
    —— clarithromycin 9(E)-oxime 127253-06-9 C38H70N2O13
    clarithromycin 9(E)-oxime
    —— (2S)-4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine dihydrogenphosphate salt 823817-58-9 C16H15F6N5O*H3O4P
    (2S)-4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine dihydrogenphosphate salt
    —— methyl 2-[(11Z)-11-[3-(dimethylamino)propylidene]-6H-benzo[c][1]benzoxepin-2-yl]acetate 113806-01-2 C22H25NO3
    methyl 2-[(11Z)-11-[3-(dimethylamino)propylidene]-6H-benzo[c][1]benzoxepin-2-yl]acetate
    —— ethyl 3-(2-phenylhydrazono)butanoate 6078-46-2 C12H16N2O2
    ethyl 3-(2-phenylhydrazono)butanoate
    —— NSC 95097 552-72-7 C22H29NO2
    NSC 95097
    —— calcium;(2R,3R,4R,5S,6R)-2,3,4,5,6,7-hexahydroxyheptanoate 17140-60-2 C14H26CaO16
    calcium;(2R,3R,4R,5S,6R)-2,3,4,5,6,7-hexahydroxyheptanoate
    —— trans-(1R,2R)-diaminocyclohexane platinum dinitrate 66900-68-3 C6H14N4O6Pt
    trans-(1R,2R)-diaminocyclohexane platinum dinitrate
    —— Clindamycin sulfoxide 22431-46-5 C18H33ClN2O6S
    Clindamycin sulfoxide
    —— benzilidenerhodanine-N-acetic acid 82159-06-6 C12H9NO3S2
    benzilidenerhodanine-N-acetic acid
    —— ethyl 4-(8-Chloro-6,11-Dihydro-5H-Benzo[5,6]Cyclohepta(1,2-b]Pyridin-11-Yl)-1-Piperidine-Carboxylate 167891-69-2 C22H25ClN2O2
    ethyl 4-(8-Chloro-6,11-Dihydro-5H-Benzo[5,6]Cyclohepta(1,2-b]Pyridin-11-Yl)-1-Piperidine-Carboxylate
    —— 4-deacetylvincristine 3704-01-6 C44H54N4O9
    4-deacetylvincristine
    —— 7β-<(E)-2-(2-amino-4-thiazolyl)-2-carboxymethoxyiminoacetamido>-3-vinyl-3-cephem-4-carboxylic acid 79350-37-1 C16H15N5O7S2
    7β-<(E)-2-(2-amino-4-thiazolyl)-2-carboxymethoxyiminoacetamido>-3-vinyl-3-cephem-4-carboxylic acid
    —— FK027 79350-37-1 C16H15N5O7S2
    FK027
    —— Benzol-anti-diazohydroxyd 36966-84-4 C6H6N2O
    Benzol-anti-diazohydroxyd
    —— (+/-)-N-formylpenicillamine 158411-82-6 C6H11NO3S
    (+/-)-N-formylpenicillamine
    —— ethyl 2,3-dioxobutanoate 2-(4-hydroxyphenyl)hydrazone 132577-23-2 C12H14N2O4
    ethyl 2,3-dioxobutanoate 2-(4-hydroxyphenyl)hydrazone