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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地瑞那韦杂质 | 4-Hydroxy Darunavir | 313682-97-2 | C27H37N3O8S |
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地氯雷他定杂质14 | 4-(8-Chloro-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-yl)-3-pyridinol 1-Oxide | 1193725-75-5 | C19H15ClN2O2 |
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地氯雷他定杂质 | 4-(10,11-dihydro-5H-dibenzo<a,d>cyclohepten-5-ylidene)piperidine | 50603-12-8 | C20H21N |
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地氯雷他定异构体 | Iso Desloratadine | 183198-49-4 | C19H19ClN2 |
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地昔卡因 | (+)-Mepivacaine | 24358-84-7 | C15H22N2O |
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地拉罗斯水杨酰酯 | 4-[2-(2-hydroxybenzoyloxy)phenyl-5-(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]benzoic acid | 1395346-28-7 | C28H19N3O6 |
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地拉罗司甲酯 | methyl 4-(3,5-bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl)benzoate | 1266741-05-2 | C22H17N3O4 |
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地拉罗司乙酯 | ethyl 4-[bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]benzoate | 201530-79-2 | C23H19N3O4 |
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地屈孕酮杂质C | 8β,9β,10α-Pregna-4,6-dien-3,20-dion | 152-62-5 | C21H28O2 |
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地尔硫卓肾上腺素 | (2S,3R)-3-acetoxy-5-<2-(dimethylamino)ethyl>-2,3-dihydro-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one | 111188-70-6 | C22H26N2O4S |
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地奈德杂质5 | Desonide glyoxal | 57171-18-3 | C24H30O6 |
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地塞米松杂质C | dexamethasone | 426-17-5 | C22H31FO5 |
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地塞米松异烟酸酯 | Dexamethasone isonicotinate | 2265-64-7 | C28H32FNO6 |
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地塞米松EP杂质K | Unii-lgt6B74heh | 1809224-82-5 | C22H26O4 |
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地加瑞克杂质 | degarelix acetate | 934016-19-0 | C2H4O2*C82H103ClN18O16 |
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圣草酚7,3',4'-三甲醚 | (-)-5-hydroxy-3',4',7-trimethoxyflavanone | 70987-96-1 | C18H18O6 |
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土霉素杂质C | Adotc cpd | 6542-44-5 | C23H25NO8 |
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土霉素杂质06 | Anhydrooxytetracycline | 4660-26-8 | C22H22N2O8 |
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四氯邻苯二甲酸单酰胺 | Tetrachlor-phthalsaeure-monoamid | 56113-42-9 | C8H3Cl4NO3 |
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四氢骆驼蓬碱 | tetrahydroharmine | 17019-01-1 | C13H16N2O |
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四氢西那卡塞盐酸盐 | (R)-α-methyl-N-[3-[3-(trifluoromethyl)phenyl]propyl]-1-(5,6,7,8-tetrahydronaphthalene)methane amine | 1229224-93-4 | C22H26F3N |
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四氢表小檗碱 | sinactine | 38853-67-7 | C20H21NO4 |
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四去氢鬼臼毒素 | dehydropodophyllotoxin | 42123-27-3 | C22H18O8 |
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噻氯吡啶杂质F | ticlopidine | 62019-75-4 | C14H14ClNS |
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噻唑基乙酰基甘氨酸肟 | Thiazolylacetyl glycine oxime | 178949-03-6 | C7H8N4O4S |
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噻吩基胺硫酸盐 | thiamine sulfate | 2380-61-2 | C12H16N4O4S2 |
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噻吗洛尔相关化合物BUSP标准品 | 3-<i>tert</i>-butylamino-2-(4-morpholin-4-yl-[1,2,5]thiadiazol-3-yloxy)-propan-1-ol | 59697-06-2 | C13H24N4O3S |
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噻吗洛尔杂质1 | (S)-(-)-N-<4-<3-<(1,1-dimethylethyl)amino>-2-hydroxypropoxy>-1,2,5-thiadiazol-3-yl>-N-(2-hydroxyethyl)glycine | 75014-25-4 | C13H24N4O5S |
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噻吗洛尔有关杂质2 | 4-(Morpholin-4-yl)-1,2,5-thiadiazol-3(2H)-one 1-oxide | 75202-36-7 | C6H9N3O3S |
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噻吗洛尔EP杂质H | 2-((2RS)-3-((1,1-Dimethylethyl)amino)-2-hydroxypropyl)-4-(morpholin-4-yl)-1,2,5-thiadiazol-3(2H)-one | 158636-97-6 | C13H24N4O3S |
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噻吗咯尔杂质E | Timolol maleate ester | 1026075-53-5 | C17H26N4O6S |
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嘧啶并[1,2-a]吲哚,2,3,4,10-四氢-3,10-二甲基- | Pefloxacin N-oxide | 85145-21-7 | C17H20FN3O4 |
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喹硫平杂质E | 1,2-Bis[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethane | 1371638-05-9 | C40H44N6O2S2 |
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喹硫平杂质7 | Quetiapine Impurity-N | 1800291-86-4 | C29H41N5O3S |
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喹硫平杂质21 | O-Dibenzo[b,f][1,4]thiazepinyl Quetiapine | 1800608-95-0 | C34H32N4O2S2 |
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喹硫平 N-氧化物 | quetiapine N<sup>19</sup>-oxide | 1076199-40-0 | C21H25N3O3S |
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喷他脒羟乙磺酸盐 | pentamidine isothionate | 140-64-7 | 2C2H6O4S*C19H24N4O2 |
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喜树碱钠盐 | Indolizino[1,2-b]quinoline-7-acetic acid,a-ethyl-9,11-dihydro-a-hydroxy-8-(hydroxymethyl)-9-oxo-, monosodiumsalt, (aS)- | 25387-67-1 | C20H18N2NaO5 |
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喜树碱杂质16 | (+)-7-ethyl-10-methoxycamptothecin | 86639-53-4 | C23H22N2O5 |
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唑吡坦杂质A | N,N-dimethyl-2-[7-methyl-2-(4-methylphenyl)imidazo[1,2-α]pyridine-3-yl]acetamide | 1346600-85-8 | C19H21N3O |
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唑吡坦杂质 | 2-bromo-1-(3-bromo-4-methylphenyl)ethan-1-one | 60208-05-1 | C9H8Br2O |
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唑吡坦6-羧酸 | 3-dimethylcarbamoylmethyl-2-(4-methylphenyl)imidazo[1,2-a]pyridine-6-carboxylic acid | 109461-15-6 | C19H19N3O3 |
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哌拉西林酸 | Piperacilloic Acid | 64817-22-7 | C23H29N5O8S |
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哌拉西林杂质 | War49C2mnx | 64844-70-8 | C23H29N5O8S |
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哌啶-3-羧酸(2,6-二甲基-苯基)-酰胺 | N-(2,6-dimethylphenyl)piperidine-3-carboxamide | 337488-90-1 | C14H20N2O |
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咪达那新相关物质6(4-ACETIMIDOYLAMINO-2,2-DIPHENYLBUTAMIDE) | 4-[(acetimidoyl)amino]-2,2-diphenylbutanamide | 503598-33-2 | C18H21N3O |
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咪达那新杂质4 | 4-amino-2-diphenylbutanamide | 503598-78-5 | C16H18N2O |
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咪达那新杂质 | 2-Ethyl-I+/-,I+/--diphenyl-1H-imidazole-1-butanenitrile | 170105-17-6 | C21H21N3 |
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咪达那新杂质 | 4-(2-Ethylimidazol-1-yl)-2,2-diphenylbutanamide | 212756-27-9 | C21H23N3O |
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咪达那新杂质 | 4-(2-methyl-1-imidazolyl)-2,2-diphenylbutyronitrile phosphate | 562091-56-9 | C20H19N3*H3O4P |
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