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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
    —— 2-cyano-4'-[2"-n-propyl-4"-methyl-6"-carboxylate-benzimidazole-1"-ylmethyl]biphenyl 1098100-87-8 C26H23N3O2
    2-cyano-4'-[2"-n-propyl-4"-methyl-6"-carboxylate-benzimidazole-1"-ylmethyl]biphenyl
    —— (R,R)-2,3-di-O-isopropylidentartaric acid mono methyl ester 3333-46-8 C5H8O6
    (R,R)-2,3-di-O-isopropylidentartaric acid mono methyl ester
    —— Zolmitriptan N-oxide 251451-30-6 C16H21N3O3
    Zolmitriptan N-oxide
    —— (S)-2-<5-<(2-oxo-1,3-oxazolidin-4-yl)methyl>-1H-indol-3-yl>ethylamine 139264-15-6 C14H17N3O2
    (S)-2-<5-<(2-oxo-1,3-oxazolidin-4-yl)methyl>-1H-indol-3-yl>ethylamine
    —— 2-(S)-amino-3-[3-(2-dimethylaminoethyl)-1H-indol-5-yl]propan-1-ol 139264-69-0 C15H23N3O
    2-(S)-amino-3-[3-(2-dimethylaminoethyl)-1H-indol-5-yl]propan-1-ol
    —— (5Z)-5-[(2E)-2-[1-[(E)-5,6-dimethylhept-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexane-1,3-diol 54573-75-0 C28H44O2
    (5Z)-5-[(2E)-2-[1-[(E)-5,6-dimethylhept-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexane-1,3-diol
    —— 3β,6α-Dihydroxy-5α-androstan-17-on 14895-71-7 C19H30O3
    3β,6α-Dihydroxy-5α-androstan-17-on
    —— Flumethason-pivalat 2002-29-1 C27H36F2O6
    Flumethason-pivalat
    —— (E)-1-[2-(acetylamino)ethylidene]-7-methoxy-1,2,3,4tetrahydronaphthalene 178677-39-9 C15H19NO2
    (E)-1-[2-(acetylamino)ethylidene]-7-methoxy-1,2,3,4tetrahydronaphthalene
    —— 2-(7-methoxy-3,4-dihydro-naphthalene-1-yl)-ethylamine hydrochloride 1353100-18-1 C13H17NO*ClH
    2-(7-methoxy-3,4-dihydro-naphthalene-1-yl)-ethylamine hydrochloride
    —— 3-ethylidenephthalide 61658-90-0 C10H8O2
    3-ethylidenephthalide
    —— 4-acetoxy-2-methyl-1-naphthol 110327-29-2 C13H12O3
    4-acetoxy-2-methyl-1-naphthol
    —— pneumocandin C0 144074-96-4 C50H80N8O17
    pneumocandin C0
    —— N<sup>10</sup>-formylfolic acid 134-05-4 C20H19N7O7
    N<sup>10</sup>-formylfolic acid
    —— S-(5'-Acetamido-2'-hydroxyphenyl)glutathion 64889-81-2 C18H24N4O8S
    S-(5'-Acetamido-2'-hydroxyphenyl)glutathion
    —— 6-(benzyloxy)-9-((1S,3R,4S)-4-(benzyloxy)-3-((benzyloxy)methyl)-2-methylidenecyclopentyl)-N-((4-methoxyphenyl)diphenylmethyl)-9H-purin-2-amine 142217-80-9 C53H49N5O4
    6-(benzyloxy)-9-((1S,3R,4S)-4-(benzyloxy)-3-((benzyloxy)methyl)-2-methylidenecyclopentyl)-N-((4-methoxyphenyl)diphenylmethyl)-9H-purin-2-amine
    —— Cyanidin 3-O-xyloside 29761-24-8 C20H19O10+
    Cyanidin 3-O-xyloside
    —— sarcosine-(2,6-dimethyl-anilide) 42459-27-8 C11H16N2O
    sarcosine-(2,6-dimethyl-anilide)
    —— 4-(ethoxycarbonyl)benzenediazonium chloride 2028-79-7 C9H9N2O2*Cl
    4-(ethoxycarbonyl)benzenediazonium chloride
    —— hydroxyitraconazole 112559-91-8 C35H38Cl2N8O5
    hydroxyitraconazole
    —— (3aR,7aR)-4-(benzo[d]isothiazol-3-yl)octahydrospiro[isoindole-2,1’-piperazin]-1'-ium mesylate 186204-37-5 CH3O3S*C19H26N3S
    (3aR,7aR)-4-(benzo[d]isothiazol-3-yl)octahydrospiro[isoindole-2,1’-piperazin]-1'-ium mesylate
    —— 2-(pentan-3-yloxy)acetaldehyde 1141364-90-0 C7H14O2
    2-(pentan-3-yloxy)acetaldehyde
    —— N-(9-methyl-9-azabicyclo[3.3.1]nonan-3-yl)-1H-indazole-3-carboxamide 107007-95-4 C17H22N4O
    N-(9-methyl-9-azabicyclo[3.3.1]nonan-3-yl)-1H-indazole-3-carboxamide
    —— N-(Formylamidino)-N'-β-D-ribofuranosylharnstoff 65126-88-7 C8H14N4O6
    N-(Formylamidino)-N'-β-D-ribofuranosylharnstoff
    —— 2β-chloromethyl-2α-methylpenicillin-3α-carboxylic acid diphenylmethyl ester 85573-73-5 C21H20ClNO3S
    2β-chloromethyl-2α-methylpenicillin-3α-carboxylic acid diphenylmethyl ester
    —— 2'-O-tosyladenosine 42776-78-3 C17H19N5O6S
    2'-O-tosyladenosine
    —— (2R,4S)-(+)-2-(2,4-dichlorophenyl)-2-<(1H-imidazol-1-yl)methyl>-1,3-dioxolane-4-methanol 61397-58-8 C14H14Cl2N2O3
    (2R,4S)-(+)-2-(2,4-dichlorophenyl)-2-<(1H-imidazol-1-yl)methyl>-1,3-dioxolane-4-methanol
    —— 1,4,8,11-tetraazabicyclo[9.3.1]pentadecane 199275-80-4 C11H24N4
    1,4,8,11-tetraazabicyclo[9.3.1]pentadecane
    —— (-)-(2S,3S)-cis-2-(diphenylmethyl)-1-azabicyclo[2.2.2]octane-3-amine 142035-23-2 C20H24N2
    (-)-(2S,3S)-cis-2-(diphenylmethyl)-1-azabicyclo[2.2.2]octane-3-amine
    —— (2-diphenylmethyl-1-azabicyclo[2.2.2]oct-3-yl)-benzylamine 155681-48-4 C27H30N2
    (2-diphenylmethyl-1-azabicyclo[2.2.2]oct-3-yl)-benzylamine
    —— ethyl 7-chloro-1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylate 70458-94-5 C14H13ClFNO3
    ethyl 7-chloro-1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylate
    —— 3β-hydroxy-9,10-secoergosta-5(E),7(E),10(19),22(E)-tetraene 51744-66-2 C28H44O
    3β-hydroxy-9,10-secoergosta-5(E),7(E),10(19),22(E)-tetraene
    —— [3-[(1R)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-(2-methylpropanoyloxy)phenyl]methyl 2-methylpropanoate 1208313-13-6 C30H43NO4
    [3-[(1R)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-(2-methylpropanoyloxy)phenyl]methyl 2-methylpropanoate
    —— (1S),3(R)-9,10-secocholesta-5(E),7(E),10(19)-triene-1,3,25-triol 73837-24-8 C27H44O3
    (1S),3(R)-9,10-secocholesta-5(E),7(E),10(19)-triene-1,3,25-triol
    —— (3bR,5aR,6R,8aR,10S)-10-((3S,5R)-3,5-Dihydroxy-2-methyl-cyclohex-1-enyl)-6-((R)-5-hydroxy-1,5-dimethyl-hexyl)-5a-methyl-2-phenyl-4,5,5a,6,7,8,8a,10-octahydro-3bH-2,3a,10a-triaza-dicyclopenta[a,f]naphthalene-1,3-dione 86307-44-0 C35H49N3O5
    (3bR,5aR,6R,8aR,10S)-10-((3S,5R)-3,5-Dihydroxy-2-methyl-cyclohex-1-enyl)-6-((R)-5-hydroxy-1,5-dimethyl-hexyl)-5a-methyl-2-phenyl-4,5,5a,6,7,8,8a,10-octahydro-3bH-2,3a,10a-triaza-dicyclopenta[a,f]naphthalene-1,3-dione
    —— (R)-N-(2-chloroallyl)-2,3-dihydro-1H-inden-1-amine 1175018-73-1 C12H14ClN
    (R)-N-(2-chloroallyl)-2,3-dihydro-1H-inden-1-amine
    —— d-biotin d-(S-oxide) 10406-89-0 C10H16N2O4S
    d-biotin d-(S-oxide)
    —— 2-oxo-2,3,9,10-tetrahydro-1H,7H-pyrido-[3',4':4,5]pyrrolo[1,2,3-de]quinoxaline-8-carboxylic acid ethyl ester 313544-31-9 C16H17N3O3
    2-oxo-2,3,9,10-tetrahydro-1H,7H-pyrido-[3',4':4,5]pyrrolo[1,2,3-de]quinoxaline-8-carboxylic acid ethyl ester
    —— 4-{4-[(S)-5-[(((4-chlorophenyl)methylene)amino)methyl]-2-oxo-1,3-oxazolidin-3-yl]phenyl}-morpholin-3-one 1414932-72-1 C21H20ClN3O4
    4-{4-[(S)-5-[(((4-chlorophenyl)methylene)amino)methyl]-2-oxo-1,3-oxazolidin-3-yl]phenyl}-morpholin-3-one
    —— (S)-N-methyl-N-phenoxycarbonyl-3-(1-naphthyloxy)-3-(2-thienyl)-1-propylamine 947686-09-1 C25H23NO3S
    (S)-N-methyl-N-phenoxycarbonyl-3-(1-naphthyloxy)-3-(2-thienyl)-1-propylamine
    —— (+)-ethyl 2-<<<(S)-1-hydroxyprop-2-yl>amino>methylene>-3-oxo-3-(2,3,4,5-tetrafluorophenyl)propionate 110548-02-2 C15H15F4NO4
    (+)-ethyl 2-<<<(S)-1-hydroxyprop-2-yl>amino>methylene>-3-oxo-3-(2,3,4,5-tetrafluorophenyl)propionate
    —— pemetrexed 182009-04-7 C20H21N5O6
    pemetrexed
    —— N-γ-aminopropylethyleneimine 1072-65-7 C5H12N2
    N-γ-aminopropylethyleneimine
    —— (3S,4R)-3-[(1R)-1-hydroxyethyl]-4-[(1R)-1-methyl-3-diazo-3-(p-nitrobenzyloxycarbonyl)-2-oxopropyl]azetidin-2-one 90822-24-5 C17H18N4O7
    (3S,4R)-3-[(1R)-1-hydroxyethyl]-4-[(1R)-1-methyl-3-diazo-3-(p-nitrobenzyloxycarbonyl)-2-oxopropyl]azetidin-2-one
    —— (R)-tert-butyl N-<1-phenyl-2-<(p-toluenesulfonyl)oxy>ethyl>carbamate 126610-77-3 C20H25NO5S
    (R)-tert-butyl N-<1-phenyl-2-<(p-toluenesulfonyl)oxy>ethyl>carbamate
    —— [(2R,3R,5S)-5-(4-amino-2-oxopyrimidin-1-yl)-3-benzoyloxy-4,4-difluorooxolan-2-yl]methyl benzoate 134790-40-2 C23H19F2N3O6
    [(2R,3R,5S)-5-(4-amino-2-oxopyrimidin-1-yl)-3-benzoyloxy-4,4-difluorooxolan-2-yl]methyl benzoate
    —— ethyl 5-benzyloxyiminopiperidine-2S-carboxylate 1416134-60-5 C15H20N2O3
    ethyl 5-benzyloxyiminopiperidine-2S-carboxylate
    —— 2-methyl-5-nitro-1-vinylimidazole 5006-79-1 C6H7N3O2
    2-methyl-5-nitro-1-vinylimidazole
    —— (E)-2',4'-dihydroxychalcone 1776-30-3 C15H12O3
    (E)-2',4'-dihydroxychalcone
    —— 6,6-dibromopenicillanic acid S,S-dioxide 76646-91-8 C8H9Br2NO5S
    6,6-dibromopenicillanic acid S,S-dioxide