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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8-氯-5,6-二氢-11H-苯并[5,6]环庚烷并[1,2-b]吡啶-11-酮 | 8-chloro-5,6-dihydro-11H-Benzo[5,6]cyclohepta[1,2-b]pyridin-11-one | 31251-41-9 | C14H10ClNO |
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8-氯-3,7-二氢-1,3,7-三甲基-1H-嘌呤-2,6-二酮 | 8-chlorocaffeine | 4921-49-7 | C8H9ClN4O2 |
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8-氯-11-(哌啶-4-亚基)-11H-苯并[5,6]环庚并[1,2-b]吡啶 | 8-CHLORO-11-(4-PIPERIDYLIDENE)-11H-BENZO[5,6]CYCLOHEPTA[1,2-b]PYRIDINE | 117811-20-8 | C19H17ClN2 |
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8-氯-1-甲基-6-苯基-4H-咪唑并[1,5-a][1,4]苯并二氮杂卓 | midazolam | 59467-86-6 | C18H14ClN3 |
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8-去甲基伊伐布雷定 | 8-Demethyl Ivabradine | 304464-97-9 | C26H34N2O5 |
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8-去乙酰基-8-羧基柔红霉素盐酸盐 | 8-Desacetyl-8-carboxy Daunorubicin Hydrochloride Hydrate | 58199-96-5 | C26H28ClNO11 |
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8-乙基伊立替康 | 8-Ethyl Irinotecan | 947687-02-7 | C35H42N4O6 |
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8-[(1R)-1-羟基-2-[[2-(4-甲氧基苯基)-1,1-二甲基乙基]氨基]乙基]-6-(苄氧基)-2H-1,4-苯并恶嗪-3(4H)-酮 | 6-benzyloxy-8-{(R)-1-hydroxy-2-[2-(4-methoxyphenyl)-1,1-dimethylethylamino]ethyl}-4H-benzo[1,4]oxazin-3-one | 869478-13-7 | C28H32N2O5 |
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8-(4-O-BETA-D-吡喃葡萄糖基-BETA-D-吡喃葡萄糖基)-5,7-二羟基-2-(4-羟基苯基)-4H-1-苯并吡喃-4-酮 | Vitexin-4''-o-glucoside | 178468-00-3 | C27H30O15 |
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8-(2R)-环氧乙烷基-6-(苄氧基)-2H-1,4-苯并恶嗪-3(4H)-酮 | 6-benzyloxy-8-(R)-oxiranyl-4H-benzo[1,4]oxazin-3-one | 869478-12-6 | C17H15NO4 |
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8-(2,3-二氯苯基)-8-氮杂-5-铵螺[4.5]癸烷溴化物 | 8-(2,3-dichlorophenyl)-8-aza-5-azoniaspiro[4,5]decane bromide | 795313-24-5 | Br*C14H19Cl2N2 |
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8-(1-甲基乙基)-8-氮杂双环[3.2.1]辛-3-酮 | 8-aza-8-isopropyl-bicyclo<3.2.1>octan-3-one | 3423-28-7 | C10H17NO |
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8,9-环氧-9,10-二异丁酰百里草酚 | 10-isobutyryloxy-8,9-epoxythymyl isobutyrate | 22518-06-5 | C18H24O5 |
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7β-氟司坦 | Fulvestrant, 7beta- | 407577-53-1 | C32H47F5O3S |
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7S-头孢地尼 | 7β-[(Z)-2-(2-amino-4-thiazolyl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid | 178601-89-3 | C14H13N5O5S2 |
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7-表克林霉素2-磷酸酯 | 7-Epiclindamycin 2-Phosphate | 620181-05-7 | C18H34ClN2O8PS |
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7-表-多西他赛 | 7-epi-docetaxel | 153381-68-1 | C43H53NO14 |
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7-表-10-氧多西他赛 | 4-epi-6-Oxodocetaxel | 162784-72-7 | C43H51NO14 |
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7-表-10-氧代-10-去乙酰基浆果赤霉素III | 10-deacetyl-10-dehydrobaccatin V | 151636-94-1 | C29H34O10 |
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7-苯乙酰胺基-3-甲基-8-氧代-5-硫杂-1-氮杂双环[4.2.0]辛-2-烯-2-甲酸 | 7-phenylacetamidodesacetoxycephalosporanic acid | 27255-72-7 | C16H16N2O4S |
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7-羟基-5-甲基-1,3,4-三氮吲哚利嗪 | 7-Hydroxy-5-methyl-1,3,4-triazaindolizine | 2503-56-2 | C6H6N4O |
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7-羟基-2-甲基-4H-1-苯并吡喃-4-酮 | 7-hydroxy-2-methyl-4H-chromen-4-one | 6320-42-9 | C10H8O3 |
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7-羟基-2-(4-羟基苯基)-2,3-二氢色烯-4-酮 | 7,4'-dihydroxy-dihydroflavone | 69097-97-8 | C15H12O4 |
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7-甲氧基-3,4-二氢喹啉-2(1H)-酮 | 7-methoxy-2-oxo-1,2,3,4-tetrahydroquinoline | 22246-17-9 | C10H11NO2 |
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7-甲氧基-3,4-二氢-1-萘基乙腈 | 2-(7-methoxy-3,4-dihydronaphthalen-1-yl)acetonitrile | 861960-34-1 | C13H13NO |
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7-甲氧基-1-萘乙酰胺 | 2-(7-methoxynaphthalen-1-yl)acetamide | 138113-07-2 | C13H13NO2 |
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7-甲氧基-1-萘乙胺 | 2-(7-methoxynaphth-1-yl)ethylamine | 138113-09-4 | C13H15NO |
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7-甲基-N-(2-(甲基氨基)苯基)-2-丙基-3H-苯并咪唑-5-羧酰胺 | 7-methyl-2-propyl-3H-benzoimidazole-5-carboxylic acid(2-methylaminophenyl)amide | 884330-18-1 | C19H22N4O |
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7-溴依匹斯汀 | 3-amino-7-bromo-9,13-dihydro-1H-dibenzo[c,f]-imidazo[1,5-a]azepine | 1217052-16-8 | C16H14BrN3 |
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7-氯-6-氟-4-氧代-1,4-二氢喹啉-3-羧酸乙酯 | ethyl 7-chloro-6-fluoro-4-oxo-1,4-dihydroquinoline 3-carboxylate | 75073-15-3 | C12H9ClFNO3 |
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7-氯-6-氟-1-对氟苯基-1,4-二氢-4-氧代-3-喹啉羧酸 | AQ-405/42300515 | 98105-79-4 | C16H8ClF2NO3 |
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7-氯-4-(4-羟基苯胺基)喹啉 | 4-[(7-chloroquinolin-4-yl)amino]phenol | 81099-86-7 | C15H11ClN2O |
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7-氯-2'-羟基-4,6-二甲氧基-6'-甲基-3H,4'H-螺[1-苯并呋喃-2,1'-环己[2]烯]-3,4'-二酮 | griseofulvic acid | 469-54-5 | C16H15ClO6 |
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7-氯-1-乙基-6-氟-4-氧氢喹啉-3-羧酸 | 7-chloro-1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid | 68077-26-9 | C12H9ClFNO3 |
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7-氯-1-乙基-6-氟-1,4-二氢-4-氧代喹啉-3-羧酸乙酯 | Ethyl 7-chloro-1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-5-carboxylate | 70458-94-5 | C14H13ClFNO3 |
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7-氯-1-[2-甲基-4-[(2-甲基苯甲酰)氨基]苯甲酰基]-5-氧代-2,3,4,5-四氢-1H-1-苯并氮杂卓 | 7-chloro-1-[2-methyl-4-[(2-methylbenzoyl)amino]benzoyl]-5-oxo-2,3,4,5-tetrahydro-1H-1-benzazepine | 137973-76-3 | C26H23ClN2O3 |
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7-氨基-8-氧代-3-[(1Z)-1-丙烯-1-基]-5-硫杂-1-氮杂双环[4.2.0]辛-2-烯-2-羧酸 | 7-amino-3-(propen-1-yl)-3-cephem-4-carboxylic acid | 106447-44-3 | C10H12N2O3S |
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7-氨基-3-(1,2,3-三唑-4-硫代)甲基-头孢环-4-羧酸 | 3-<(1H-1,2,3-triazol-4-ylthio)methyl>cephem | 37539-03-0 | C10H11N5O3S2 |
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7-去甲氧基-7-乙氧基-42-O-(2-羟基乙基)雷帕霉素 | 2Cya2X8ztl | 1704711-12-5 | C54H85NO14 |
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7-去甲基伊伐布雷定 | 7-Demethyl Ivabradine | 304462-60-0 | C26H34N2O5 |
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7-乙酰基紫杉醇 | 7-acetylpaclitaxel | 92950-39-5 | C49H53NO15 |
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7-乙基喜树碱1-氧化物 | 7-Ethylcamptothecin 1-Oxide | 86639-51-2 | C22H20N2O5 |
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7-乙基-5-氧代-5H-[1]苯并吡喃并[2,3-b]吡啶 | 7-ethyl-5H-[1]-benzopyrano [2,3-b] pyridin-5-one | 53944-31-3 | C14H11NO2 |
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7-乙基-3-羟乙基吲哚 | 7-ethyltryptophol | 41340-36-7 | C12H15NO |
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7-[[[[(氰基甲基)硫代]乙酰基]氨基]-7-甲氧基头孢烷酸 | 7-[[[(Cyanomethyl)thio]acetyl]amino]-7-methoxy Cephalosporanic Acid | 56796-16-8 | C15H17N3O7S2 |
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7-[4-[4-(2,3-二氯苯基)-1-氧代-1-哌嗪基]丁氧基]-3,4-二氢-2(1H)-喹啉酮 | 7-{4-[4-(2,3-dichlorophenyl)-1-piperazinyl] (1N-oxo) butoxy}-3,4-dihydro-2(1H)-quinolinone | 573691-09-5 | C23H27Cl2N3O3 |
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7-[4-(2-哌啶基)乙氧基]苯甲酰基雷洛昔芬 | 6-hydroxy-2-(4-hydroxyphenyl)-3-[4-(2-piperidinoethoxy)benzoyl]-7-[4-(2-piperidinoethoxy)benzoyl]benzo[b]thiophene | 1159977-58-8 | C42H44N2O6S |
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7-[(R)-(四氢呋喃-3-基)氧基]-N-(3-氯-4-氟苯基)-6-[(二乙氧基磷酰基)-乙酰氨基]-4-氨基喹唑啉 | 4-[(3-chloro-4-fluoro-phenyl)amino]-6-[(diethoxy-phosphoryl)-acetylamino]-7-[(R)-(tetrahydrofuran-3-yl)oxy]-quinazoline | 618061-77-1 | C24H27ClFN4O6P |
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7-[(7S)-7-氨基-5-氮杂螺[2.4]庚烷-5-基]-8-氯-6-氟-1-[(1S,2R)-2-氟环丙基]-1,4-二氢-4-氧代-3-喹啉甲酸 | 7-((S)-7-Amino-5-aza-spiro[2.4]hept-5-yl)-8-chloro-6-fluoro-1-((1S,2R)-2-fluoro-cyclopropyl)-4-oxo-1,4-dihydro-quinoline-3-carboxylic acid | 127254-11-9 | C19H18ClF2N3O3 |
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7-O-当归酰天芥菜定 | 7-angeloylheliotridine | 723-78-4 | C13H19NO3 |
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