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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7-ADCA 特戊酰胺 | (6R,7R)-7-[(2,2-dimethyl-1-oxopropyl)amino]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid | 146794-70-9 | C13H18N2O4S |
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7-(苯氧基)-5-溴-2-甲基-1H-苯并唑[D]咪唑 | 6-bromo-2-methyl-4-[(phenylmethyl)oxy]-1H-benzimidazole | 774582-60-4 | C15H13BrN2O |
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7-(4-氯丁氧基)-2(1H)-喹啉酮 | 7-(4-chlorobutoxy)-1H-quinolin-2-one | 913613-82-8 | C13H14ClNO2 |
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7-(2-氨基乙基氨基)-1-环丙基-6-氟-4-氧代喹啉-3-羧酸 | Desethyleneciprofloxacin | 103222-12-4 | C15H16FN3O3 |
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7-(2,2-二乙氧基乙基)-1,3-二甲基-3,7-二氢-1H-嘌呤-2,6-二酮 | 7-(2',2'-Diethoxyethyl)-theophyllin | 43135-57-5 | C13H20N4O4 |
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7,8,9,10-去氢多柔比星酮 | 7,8,9,10-Dehydro Doxorubicinone | 1159977-23-7 | C21H14O8 |
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7,7-二甲氧基-[4,4]bi[苯并[1,3]二氧代]-5,5-二羧酸 | 4,4'-dimethoxy-5,6,5',6'-dimethylenedioxy-2,2'-dibenzoic acid | 105868-34-6 | C18H14O10 |
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7,10-二(2,2,2-三氯乙氧羰基)-10-脱乙酰基巴卡丁 III | 7,10-di-(2,2,2-trichloroethyloxycarbonyl)-10-deacetylbaccatin III | 95603-44-4 | C35H38Cl6O14 |
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6α-甲基氢化可的松-21-半琥珀酸酯-d4(主要) | 6alpha-Methyl Hydrocortisone 21-Hemisuccinate | 119657-85-1 | C26H36O8 |
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6beta-甲泼尼龙 | 6β-methylprednisolone | 18462-27-6 | C22H30O5 |
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6alpha-甲基氢化可的松21-乙酸酯 | 21-acetoxy-11β,17-dihydroxy-6α-methyl-pregn-4-ene-3,20-dione | 1625-11-2 | C24H34O6 |
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6alpha-氯倍氯米松二丙酸酯 | 6alpha-Chloro-beclomethasone dipropionate | 887130-68-9 | C28H36Cl2O7 |
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6alpha-氟-11beta,21-二羟基-16alpha-甲基孕甾-1,4-二烯-3,20-二酮 21-特戊酸酯 | Fluocortolone Pivalate | 29205-06-9 | C27H37FO5 |
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6N-羟甲基替诺福韦二吡呋酯 | 2,4,6,8-Tetraoxa-5-phosphanonanedioic acid, 5-[[(1R)-2-[6-[(hydroxymethyl)amino]-9H-purin-9-yl]-1-methylethoxy]methyl]-, 1,9-bis(1-methylethyl) ester, 5-oxide | 1244022-53-4 | C20H32N5O11P |
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6-苄氧基-9-((1S,3R,3S)-4-苄氧基-3-苄氧基甲基-2-亚甲基环戊基)-N-((4-甲氧基苯基)二苯基甲基)-9H-嘌呤-2-胺 | 6-(Benzyloxy)-9-((1S,3S)-4-(benzyloxy)-3-((benzyloxy)methyl)-2-methylenecyclopentyl)-N-((4-methoxyphenyl)diphenylmethyl)-9H-purin-2-amine | 142217-80-9 | C53H49N5O4 |
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6-苄氧-8-((R)-2-氯-1-羟基-乙基-4H-苯并[1,4]-噁嗪-3-酮 | 6-benzyloxy-8-((R)-2-chloro-1-hydroxyethyl)-4H-benzo[1,4]-oxazin-3-one | 869478-11-5 | C17H16ClNO4 |
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6-羟基木犀草苷 | 6-hydroxyluteolin 7-glucoside | 54300-65-1 | C21H20O12 |
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6-羟基昂丹司琼 | 6-Hydroxyondansetron | 110708-17-3 | C18H19N3O2 |
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6-羟基山奈酚3-芸香糖-6-葡萄糖苷 | 6-Hydroxykaempferol 3-rutinoside-6-glucoside | 145134-63-0 | C33H40O21 |
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6-羟基尼可地尔 | 6-Hydroxy Nicorandil | 113743-17-2 | C8H9N3O5 |
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6-羟基地氯雷他定 | 6-Hydroxydesloratadine | 119410-05-8 | C19H19ClN2O |
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6-羟基l氨基尿嘧啶 | N<sup>4</sup>-hydroxycytosine | 20555-88-8 | C4H5N3O2 |
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6-羟基-5-甲氧基-1-茚酮 | 6-hydroxy-5-methoxyindan-1-one | 90843-62-2 | C10H10O3 |
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6-甲氧基紫云英苷 | 6-Methoxykaempferol 3-O-glucoside | 63422-27-5 | C22H22O12 |
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6-甲基泼尼松 | 17α,21-dihydroxy-6α-methylpregna-1,4-diene-3,11,20-trione | 111264-84-7 | C22H28O5 |
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6-甲基-2,4-蝶啶二胺 | 2,4-diamino-6-methylpteridine | 708-74-7 | C7H8N6 |
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6-溴-alpha-[2-(二甲基氨基)乙基]-2-甲氧基-alpha-1-萘基-beta-苯基-3-喹啉乙醇 | bedaquiline | 654655-80-8 | C32H31BrN2O2 |
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6-溴-4-羰基-1,4-二氢喹啉-3-甲腈 | (2S)-2-[(3S,8aS)-3-(4-aminobutyl)-1,4-dioxohexahydropyrrolo[1,2-a]pyrazine-2(1H)-yl]-4-phenylbutanoic acid | 328385-86-0 | C21H29N3O4 |
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6-溴-3H-异苯并呋喃-1-酮 | 6-bromophthalide | 19477-73-7 | C8H5BrO2 |
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6-氯-5(s)-羟基-3-氧代己酸叔丁酯 | Tert-butyl (5S)-6-chloro-5-hydroxy-3-oxohexanoate | 154026-92-3 | C10H17ClO4 |
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6-氯-4-甲基-3-氧代-3,4-二氢-2H-1,4-苯并嗪-8-羧酸 | 6-chloro-3,4-dihydro-4-methyl-3-oxo-2H-1,4-benzoxazine-8-carboxylic acid | 123040-79-9 | C10H8ClNO4 |
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6-氯-2-乙氧基-9-吖啶胺 | 6-Chloro-2-ethoxyacridin-9-amine | 855939-48-9 | C15H13ClN2O |
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6-氯-1H-苯并[d]咪唑-2-氨基甲酸甲酯 | 2-Carbomethoxyamino-5-chlorbenzimidazol | 20367-38-8 | C9H8ClN3O2 |
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6-氯-1-甲基尿嘧啶 | 6-chloro-1-methyluracil | 31737-09-4 | C5H5ClN2O2 |
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6-氯-1-甲基-4-苯基喹唑啉-2-酮 | 6-chloro-1-methyl-4-phenyl-2(1H)-quinazolinone | 20927-53-1 | C15H11ClN2O |
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6-氨基-5-甲酰氨基-1,3-二甲基尿嘧啶 | 1,3-dimethyl-4-amino-5-(formylamino)uracil | 7597-60-6 | C7H10N4O3 |
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6-氨基-5-氮杂胞苷 | 6-amino-5-azacytidine | 105331-00-8 | C8H13N5O5 |
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6-氨基-2-乙氧基9(10H)-吖啶酮 | 6-amino-2-ethoxyacridin-9(10H)-one | 144335-20-6 | C15H14N2O2 |
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6-差向多西环素盐酸盐 | 6-epi-doxycycline hydrochloride | 41411-66-9 | C22H24N2O8*ClH |
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6-去氢黄体酮 | 6-dehydroprogesterone | 1162-56-7 | C21H28O2 |
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6-[3-(1-金刚烷基)-4-甲氧基苯基]-2-萘甲酸甲酯 | methyl 6-(3-(1-adamantyl)-4-methoxyphenyl)-2-naphthoate | 106685-41-0 | C29H30O3 |
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6-O-甲基可待因 | codeine-6-methyl ether | 2859-16-7 | C19H23NO3 |
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6-O-去甲基多奈哌齐 | 6-O-desmethyldonepezil | 120013-56-1 | C23H27NO3 |
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6-(苄氧基)-8-(2-溴乙酰基)-2H-苯并[b][1,4]噁嗪-3(4h)-酮 | 8-(bromoacetyl)-6-benzyloxy-2H-1,4-benzoxazin-3(4H)-one | 926319-53-1 | C17H14BrNO4 |
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6-(苄氧基)-8-(2-氯乙酰基)2H-苯并[1,4]恶嗪-3(4H)-酮 | 6-benzyloxy-8-(2-chloro-acetyl)-4H-benzo[1,4]oxazin-3-one | 869478-10-4 | C17H14ClNO4 |
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6-({3-[4-(4-羟基-2-甲氧基苯基)-1-哌嗪基]丙基}氨基)-1,3-二甲基-2,4(1H,3H)-嘧啶二酮 | 4-Hydroxyurapidil | 88733-12-4 | C20H29N5O4 |
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6-(5-氯-2-吡啶基)-6,7-二氢-7-羟基-5H-吡咯并[3,4-b]吡嗪-5-酮 | 6-(5-chloropyridin-2-yl)-7-hydroxy-6,7-dihydropyrrolo[3,4-b]pyrazin-5-one | 43200-81-3 | C11H7ClN4O2 |
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6-(4-(乙氧基羰基)哌啶-1-基)-5-氯吡啶-3-羧酸 | 5-chloro-6-(4-(ethylformat)piperidin-1-yl)nicotinic acid | 931395-73-2 | C14H17ClN2O4 |
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6-(3-氯苯基)-1,3,5-三嗪-2,4-二胺 | 2,4-Diamino-6-(m-chlorphenyl)-s-triazin | 4514-54-9 | C9H8ClN5 |
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6-(2-氯乙氧基)-N-(3-乙炔基苯基)-7-(2-甲氧基乙氧基)喹唑啉-4-胺盐酸盐 | 6-(2-chloroethoxy)-N-(3-ethynylphenyl)-7-(2-methoxyethoxy)quinazolin-4-amine hydrochloride | 183320-04-9 | C21H20ClN3O3*ClH |
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