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 |
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3-羟基西酞普兰 | 3-hydroxycitalopram | 411221-53-9 | C20H21FN2O2 |
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3-羟基苯基三甲基铵碘化物 | 3-(trimethylammonio)phenol iodide | 2498-27-3 | C9H14NO*I |
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3-羟基硫代苯甲酰胺 | 3-hydroxybenzenecarbothioamide | 104317-54-6 | C7H7NOS |
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3-羟基四氢呋喃 | (S)-3-hydroxytetrahydrothiophene | 79107-75-8 | C4H8OS |
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3-羟基-4-甲基-2(5H)-噻吩酮 | 3-hydroxy-4-methyl-2(5H)-thiophenone | 34876-35-2 | C5H6O2S |
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3-羟基-2,4-二甲氧基苯甲醛 | 3-hydroxy-2,4-dimethoxybenzaldehyde | 32246-34-7 | C9H10O4 |
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3-硝基苯乙炔 | 3-nitrophenylacetylene | 3034-94-4 | C8H5NO2 |
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3-硝基-4-苯氧基苯甲醚 | 3-nitro-4-phenoxyanisole | 84594-95-6 | C13H11NO4 |
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3-硝基-4-苯氧基-5-磺酰基苯甲酸 | 3-nitro-4-phenoxy-5-sulfamoylbenzoic acid | 28328-53-2 | C13H10N2O7S |
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3-硝基-4-甲基-N-(3-(4-甲基-1H-咪唑-1-基)-5-(三氟甲基)苯基)苯甲酰胺 | 3-nitro-4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5(trifluoromethyl)phenyl)benzamide | 1157857-29-8 | C19H15F3N4O3 |
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3-甲氧基-L-酪氨酸 | 3-O-methyldopa | 300-48-1 | C10H13NO4 |
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3-甲氧基-2-甲基-4-硝基吡啶1-氧化物 | 3-methoxy-2-methyl-4-nitropyridine 1-oxide | 15931-25-6 | C7H8N2O4 |
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3-甲基黄酮-8-羧酸乙酯 | Ethyl 3-methylflavone-8-carboxylate | 35888-94-9 | C19H16O4 |
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3-甲基黄酮-8-羧酸 | 3-methylflavone-8-carboxylic acid | 3468-01-7 | C17H12O4 |
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3-甲基-8-喹啉磺酸 | 3-methyl-8-quinolinesulfonic acid | 153886-69-2 | C10H9NO3S |
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3-甲基-4-氧代吡嗪-1-鎓1-氧化物 | 2-methylpyrazine-1,4-di-N-oxide | 32046-26-7 | C5H6N2O2 |
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3-甲基-4,5-二苯基异恶唑 | 3-methyl-4,5-diphenylisoxazole | 75115-00-3 | C16H13NO |
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3-甲基-2-苯并呋喃-1(3H)-酮 | 3-methylphthalide | 3453-64-3 | C9H8O2 |
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3-甲基-2-(3,4-二甲氧基苯基)丁腈 | 2-(3,4-dimethoxyphenyl)-3-methylbutyronitrile | 20850-49-1 | C13H17NO2 |
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3-溴卡比多巴 | 3-(3-Bromo-4,5-dihydroxyphenyl)-2-hydrazinyl-2-methylpropanoic acid | 1246819-09-9 | C10H13BrN2O4 |
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3-溴-5-氯吡嗪-2-甲腈 | 3-bromo-5-chloro-pyrazine-2-carbonitrile | 440124-25-4 | C5HBrClN3 |
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3-氰基-5-甲基己酸 | 3-cyano-5-methylhexanoic acid | 181289-16-7 | C8H13NO2 |
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3-氰基-4-异丁氧基苯甲酸 | 3-cyano-4-isobutyloxybenzoic acid | 528607-60-5 | C12H13NO3 |
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3-氰基-4-异丁氧基苯甲酰胺 | 3-Cyano-4-isobutoxybenzamide | 161718-85-0 | C12H14N2O2 |
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3-氰基-4-异丁氧基硫代苯甲酰胺 | 3-cyanoisobutoxybenzothioamide | 163597-57-7 | C12H14N2OS |
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3-氯咪唑并[1,2-b]吡嗪-2-羧酸甲酯 | 5-methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-yl-1-oxide)methyl]sulfonyl]-1H-benzimidazole | 158812-85-2 | C17H19N3O5S |
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3-氯亚氨基二苄 | 3-chloro-10,11-dihydro-5H-dibenzo[b,f]azepine | 32943-25-2 | C14H12ClN |
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3-氯-N-(3-甲氧基苯基)丙酰胺 | 3-chloro-N-(3-methoxyphenyl)propanamide | 21261-76-7 | C10H12ClNO2 |
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3-氯-4-吗啉基-1,2,5-噻二唑 | 4-(4-chloro-1,2,5-thiadiazol-3-yl)morpholine | 30165-96-9 | C6H8ClN3OS |
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3-氯-2-羟基丙腈 | (RS)-chloroacetaldehyde cyanohydrin | 33965-80-9 | C3H4ClNO |
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3-氨基磺酰基-5-丁基氨基-4-苯氧基苯甲酸丁酯 | butyl 3-aminosulfonyl-5-butylamino-4-phenoxybenzoate | 32643-00-8 | C21H28N2O5S |
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3-氨基-5-[(甲基硫代)甲基]噁唑啉-2-酮 | N-amino-5-methylthiomethyl-2-oxazolidinone | 25517-72-0 | C5H10N2O2S |
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3-氨基-5-(氨基磺酰基)-4-苯氧基苯甲酸 | 3-amino-4-phenoxy-5-sulfamoylbenzoic acid | 28328-54-3 | C13H12N2O5S |
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3-氨基-4-苯氧基苯甲醚 | 5-methoxy-2-phenoxyaniline | 76838-72-7 | C13H13NO2 |
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3-氨基-4-甲基-N-(3-(4-甲基-1H-咪唑-1-基)-5-(三氟甲基)苯基)苯甲酰胺 | 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-aminobenzamide | 915711-42-1 | C19H17F3N4O |
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3-氨基-4-氰基吡唑 | 3-amino-4-cyano-2H-pyrazole | 16617-46-2 | C4H4N4 |
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3-氨基-4-亚氨基-利福霉素 | 3-amino-4-imino-rifamycin S | 62041-01-4 | C37H47N3O11 |
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3-氨基-4-(2-氯苯基)-6-硝基-2(1H)-喹啉酮 | 3-Amino-4-(2-chlorphenyl)-6-nitro-2(1H)-chinolinon | 55198-89-5 | C15H10ClN3O3 |
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3-氨基-3-氮杂二环[3.3.0]辛烷 | N-amino-3-azabicyclo<3.3.0>octane | 54528-00-6 | C7H14N2 |
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3-氨基-1,2-二氢-6-氯-1-甲基-4-苯基喹啉-2(1H)-酮 | 3-amino-6-chloro-1,2-dihydro-1-methyl-2-oxo-4-phenylquinoline | 5220-02-0 | C16H13ClN2O |
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3-氧代-3-(2,4,5-三氟-3-甲氧基苯基)-丙酸乙酯 | ethyl 3-oxo-3-(2,4,5-trifluoro-3-methoxyphenyl)propionate | 112811-68-4 | C12H11F3O4 |
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3-氧代-1,3-二氢异苯并呋喃-1-膦酸二甲酯 | dimethyl (3-oxo-1,3-dihydroisobenzofuran-1-yl)phosphonate | 61260-15-9 | C10H11O5P |
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3-氟-4-羟基联苯基 | 3-fluoro-4-phenylphenol | 477860-13-2 | C12H9FO |
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3-异丙基-4-丁内酯 | (S)-4-Isopropyl-dihydro-furan-2-one | 10547-88-3 | C7H12O2 |
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3-己基-4-羟基-6-十一烷基四氢-2H-吡喃-2-酮 | (3S,4S,6S)-3-hexyl-4-hydroxy-6-undecyltetrahydro-2H-pyran-2-one | 68711-33-1 | C22H42O3 |
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3-巯基异丁酸 | 2-methyl-3-sulfanylpropanoic acid | 26473-47-2 | C4H8O2S |
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3-噻吩乙醇酯 | 2-(thiophen-3-yl)ethyl 4-methylbenzenesulfonate | 40412-09-7 | C13H14O3S2 |
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3-噻吩丙胺-N,N-二甲基-gamma-(1-萘氧基)-乙二酸酯 | 3-Thiophenepropanamine, N,N-dimethyl-gamma-(1-naphthalenyloxy)-, ethanedioate(1:1) | 116817-26-6 | C21H23NO5S |
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3-去甲氧基-3-溴甲氧苄啶 | 2,4-diamino-5-(3',4'-dimethoxy-5'-bromobenzyl)pyrimidine | 16285-82-8 | C13H15BrN4O2 |
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3-去甲基硫代秋水仙碱 | 3-O-demethylthiocolchicine | 87424-25-7 | C21H23NO5S |
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