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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17,21-二羟基-16alpha-甲基孕甾-1,4,9(11)-三烯-3,20-二酮 | VBP-15 | 13209-41-1 | C22H28O4 |
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16β-甲基-17α-二羟基孕-1,4-二烯-3,20-二酮 | 16β-methyl-1,4-pregnadiene-17α,21-diol-3,20-dione | 18383-24-9 | C22H30O4 |
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16alpha-甲基-11-氧代泼尼松龙 | methylprednisone | 2036-77-3 | C22H28O5 |
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16alpha,17,21-三羟基-孕甾-1,4-二烯-3,11,20-三酮 | 11-Keto-16alpha-hydroxyprednisolone | 3754-05-0 | C21H26O6 |
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16-羟基红霉素 | Erythromycin F | 82230-93-1 | C37H67NO14 |
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16-妊娠双烯醇酮 | 16-dehydropregnenolone | 1162-53-4 | C21H30O2 |
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16-去甲基-16-羟甲基利福昔明 | 16-Desmethyl-16-(hydroxymethyl)rifaximin | 1210022-90-4 | C43H51N3O12 |
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15-氧代比马前列素 | (5Z)-7-{(1R,2R,3R,5S)-3,5-dihydroxy-2-[(1E)-3-oxo-5-phenylpent-1-en-1-yl]cyc!opentyl}-N-ethylhept-5-enamide | 1163135-96-3 | C25H35NO4 |
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15,16-脱羟基3-O-苄基雌甾醇17-乙酸酯 | 15,16-Deshydroxy 3-O-Benzyl Estetrol 17-Acetate | 690996-25-9 | C27H30O3 |
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14-乙基-4,6,7,12-四羟基-3,5,7,9,11,13-六甲基-1-氧杂环十四烷-2,10-二酮 | erythronolide B | 3225-82-9 | C21H38O7 |
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14,15-去氢曲安奈德 | delta14-Triamcinolone acetonide | 1260149-96-9 | C24H29FO6 |
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14,15-去氢布地奈德 | 14,15-Dehydro Budesonide | 131918-64-4 | C25H32O6 |
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14,15-二氢阿扑长春胺乙酯 | 3α-deoxyvincaminic acid ethyl ester | 57327-92-1 | C22H28N2O2 |
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13-顺式维生素A棕榈酸酯 | 9-Palmitoyloxy-3.7-dimethyl-1<i>t</i>-(2.2.6-trimethyl-cyclohexen-(6)-yl)-nonatetraen-(1.3<i>t</i>.5<i>t</i>.7<i>c</i>) | 26771-20-0 | C36H60O2 |
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13-氧代-1,4,7,10-四氮杂双环[8.2.1]十三烷-4,7-二乙酸 | 1,4,7,10-tetraazabicyclo[8.2.1 ]tridecane-13-on-4,7-diacetic acid | 229312-33-8 | C13H22N4O5 |
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12-羟基伊立替康 | 12-Hydroxy Irinotecan | 185336-12-3 | C33H38N4O7 |
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12-O-甲基克拉霉素 | 6,11-di-O-methylerythromycin A | 128940-83-0 | C39H71NO13 |
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11beta-羟基地诺孕素 | 17α-Cyanomethyl-11β,17β-dihydroxy-estra-4,9-dien-3-on | 86153-39-1 | C20H25NO3 |
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11alpha,17,21-三羟基-16beta-甲基孕甾-1,4-二烯-3,20-二酮 | 16β-methyl-11β,17,α21-trihydroxypregna-1,4-diene-3,20-dione | 85700-75-0 | C22H30O5 |
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11A.17A-二羟基黄体酮 | 11α,17α-dihydroxypregn-4-ene-3,20-dione | 603-98-5 | C21H30O4 |
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11-脱氧泼尼松龙 | prednisolone | 1807-14-3 | C21H28O4 |
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11-氧代奥卡西平 | 11-keto oxcarbazepine | 537693-29-1 | C15H10N2O3 |
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11-氟去氯雷他定 | 11-Fluoro Desloratadine | 298220-99-2 | C19H20ClFN2 |
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11-乙基-5,11-二氢-4-甲基-6H-二吡啶并[3,2-b:2',3'-e][1,4]二氮杂卓-6-酮 | 5,11-dihydro-11-ethyl-4-methyl-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one | 133627-17-5 | C14H14N4O |
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11-[3-(二甲基氨基)丙基]-6,11-二氢二苯并[b,e]氧杂卓-11-醇 | 11-Hydroxy-11-(3-dimethylamino-propyl)-6,11-dihydro-dibenzo<b.e>oxepin | 4504-88-5 | C19H23NO2 |
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11-(4-乙基哌嗪-1-基)二苯并[b,f][1,4]硫氮杂卓 | 11-[4-ethyl-1-piperazinyl]dibenzo[b,f][1,4]thiazepine | 1011758-03-4 | C19H21N3S |
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11,11'-(1,4-哌嗪二基)二(8-氯-5H-二苯并[b,e][1,4]二氮杂卓) | 11,11'-(Piperazine-1,4-diyl)-bis-8-chloro-5H-dibenze[b,e][1,4]-diazepine | 263366-81-0 | C30H24Cl2N6 |
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10ALPHA-羟基纳呋拉啡 | (E)-N-[17-(cyclopropylmethyl)-4,5α-epoxy-3,10α,14β-trihydroxymorphinan-6β-yl]-3-(furan-3-yl)-N-methylprop-2-enamide | 1054312-75-2 | C28H32N2O6 |
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10-羰基-10-DAB | 10-dehydro 10-deacetyl 7-epibaccatin V | 92950-45-3 | C29H34O10 |
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10-甲氧基亚氨基芪-5-甲酰氯 | 10-methoxyiminostilbene carbonyl chloride | 28721-08-6 | C16H12ClNO2 |
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10-甲氧基-9,10-二氢麦角醇 | 10α-methoxy-9,10-dihydrolysergol | 35121-60-9 | C17H22N2O2 |
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10-溴-5H-二苯并[b,f]氮杂卓-5-甲酰胺 | 10-Bromcarbamazepin | 59690-97-0 | C15H11BrN2O |
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10-氧多西他赛 | 10-oxodocetaxel | 167074-97-7 | C43H51NO14 |
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10-反式阿托伐他汀丙酮化物叔丁酯 | tert-butyl (4S,6R)-6-{2-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrol-1-yl]ethyl}-2,2-dimethyl-1,3-dioxane-4-acetate | 1105067-90-0 | C40H47FN2O5 |
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10-去氮杂氨基蝶呤 | 10-deazaaminopterin | 52454-37-2 | C20H21N7O5 |
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10-乙酰氧基奥卡西平 | 5-carbamoyl-10,11-dihydro-11-oxo-5H-dibenz<b,f>azepine-10-yl acetate | 113952-21-9 | C17H14N2O4 |
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10-[4-(1-哌啶基)-1-哌啶基羰基氧基]喜树碱 | 10-[4-(1-piperidino)-1-piperidino]carbonyloxycamptothecin | 103816-16-6 | C31H34N4O6 |
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10-[3-[4-(2-羟乙基)-10哌嗪)丙基]吩噻嗪-2-基甲酮马来酸盐 | Ketone, dimaleate | 5714-00-1 | C27H33N3O6S |
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10-(3-二甲基氨基-2-甲基丙基)-2-甲氧基吩噻嗪盐酸盐 | Levomepromazine hydrochloride | 1236-99-3 | C19H24N2OS*ClH |
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10,11-二氢二苯并[a,b]环庚烯-5-酮 | 10,11-Dihydro-5H-dibenzo[a,d]cyclohepten-5-one | 1210-35-1 | C15H12O |
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1-苯并呋喃-5-甲酸 | benzofuran-5-carboxylic acid | 90721-27-0 | C9H6O3 |
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1-苯基庚-1-烯-3-醇 | (1E)-1-phenylhept-1-en-3-ol | 109801-00-5 | C13H18O |
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1-苯基-3,4-二氢异喹啉 | 1-phenyl-3,4-dihydroisoquinoline | 52250-50-7 | C15H13N |
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1-苯基-1-庚烯-3-醇 | (S)-(E)-1-phenyl-hept-1-en-3-ol | 20157-19-1 | C13H18O |
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1-苄基-4-苯基哌啶-4-醇 | 1-benzyl-4-hydroxy-4-phenylpiperidine | 63843-83-4 | C18H21NO |
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1-苄基-4-乙氧基苯 | 1-benzyl-4-ethoxybenzene | 35672-52-7 | C15H16O |
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1-苄基-4-(5、6二甲氧基-1-茚酮-2-亚甲基)-哌啶 | 1-benzyl-4-<(5,6-dimethoxy-1-oxoindan-2-ylidenyl)methyl>piperidine | 120014-07-5 | C24H27NO3 |
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1-苄基-4-(5,6-二甲氧基-1H-2-茚基甲基)哌啶 | 1-benzyl-4-(5,6-dimethoxy-1H-2-indenyl-methyl)piperidine | 120013-45-8 | C24H29NO2 |
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1-苄基-4-((5,6-二甲氧基-2,3-二氢-1H-茚-2-基)甲基)哌啶盐酸盐 | 2-[(1-benzylpiperidin-4-yl)methyl]-5,6-dimethoxyindane hydrochloride | 1034439-57-0 | C24H31NO2*ClH |
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1-苄基-3-甲氨基-4-甲基哌啶 | (1-benzyl-4-methyl-piperidin-3-yl)-methyl-amine | 384338-23-2 | C14H22N2 |
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