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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去甲文拉法辛氮氧化合物杂质 | venlafaxine O-desmethyl N-oxide | 1021933-95-8 | C16H25NO3 |
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去甲文拉法辛(O-去甲文拉法辛)琥珀酸 | desvenlafaxine succinate | 448904-47-0 | C4H6O4*C16H25NO2 |
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去甲文拉法辛(O-去甲文拉法辛)延胡索酸酯 | (+/-)-1-[2-dimethylamino-1-(4-hydroxyphenyl)-ethyl]-cyclohexanol fumarate | 93414-04-1 | C4H4O4*C16H25NO2 |
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去甲基马来酸盐氯苯那敏 | Desmethyl Chlorpheniramine Maleate Salt | 22630-25-7 | C19H21ClN2O4 |
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去甲基米安色林 | desmethylmianserin | 71936-92-0 | C17H18N2 |
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去甲基盐酸氯丙嗪 | 2-chloro-N-methyl-10H-phenothiazine-10-propanamine hydrochloride | 3953-65-9 | C16H17ClN2S*ClH |
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去甲基波生坦 | Desmethyl Bosentan | 253688-61-8 | C26H27N5O6S |
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去甲基氮卓斯汀 | Desmethylazelastine | 47491-38-3 | C21H22ClN3O |
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去甲基哌嗪基异西地那非磺酰氯 | 5-(5-chlorosulfonyl-2-ethoxyphenyl)-2-methyl-3-propyl-6,7-dihydro-2H-pyrazolo[4,3-d]pyrimidin-7-one | 501120-42-9 | C17H19ClN4O4S |
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去甲基厄洛替尼羧酸酯酸 | Desmethyl Erlotinib Carboxylate Acid | 882172-60-3 | C21H19N3O5 |
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去甲基厄洛替尼乙酸酯 | 6-(2-acetoxyethoxy)-4-(3-ethynylphenylamino)-7-(2-methoxyethoxy)quinazoline | 183320-15-2 | C23H23N3O5 |
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去甲基他克莫司 | 13-Desmethyl FK 506 | 132172-14-6 | C43H67NO12 |
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去甲哌嗪基去乙基西地那非磺酰氯 | 5-(5-chlorosulphonyl-2-hydroxyphenyl)-1-methyl-3-n-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one | 139756-27-7 | C15H15ClN4O4S |
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去甲利多卡因盐酸盐 | monoethylglycine xylidide hydrochloride | 7729-94-4 | C12H18N2O*ClH |
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去环丙基甲基纳呋拉啡 | Descyclopropylmethyl Nalfurafine | 163713-06-2 | C24H26N2O5 |
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去氯雷他定-N-羟基哌啶 | Desloratadine N-Hydroxypiperidine | 1193725-73-3 | C19H19ClN2O |
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去氨甲碘安 | 3',3,5-triiodothyropropionic acid | 51-26-3 | C15H11I3O4 |
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去氧肾上腺素碱 | Phenylephrin | 59-42-7 | C9H13NO2 |
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去氧穿心莲内酯 | 14-deoxyandrographolide | 4176-97-0 | C20H30O4 |
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去氢阿折地平 | 3-(1-benzhydrylazetidin-3-yl) 5-isopropyl 2-amino-6-methyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate | 918659-10-6 | C33H32N4O6 |
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去氢吲达帕胺 | Dehydroindapamide | 63968-75-2 | C16H14ClN3O3S |
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去氢利福昔明 | Dehydro Rifaximin | 80621-76-7 | C43H49N3O11 |
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去氢伊伐布雷定 | 3-{3-[{[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl}-(methyl)amino]propyl}-7,8-dimethoxy-1,3-dihydro-2H-3-benzazepin-2-one | 1086026-31-4 | C27H34N2O5 |
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去氟盐酸恩诺沙星 | 1-cyclopropyl-1,4-dihydro-4-oxo-7-(piperazin-1-yl)-quinoline-3-carboxylic acid | 93107-11-0 | C17H19N3O3 |
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去氟氟伏沙明 | Desfluoro Fluvoxamine | 1217214-94-2 | C15H22F2N2O2 |
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去氟利司哌酮 | 3-[2-[4-(1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one | 106266-09-5 | C23H28N4O2 |
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去氟依折麦布 | Desfluoro Ezetimibe | 302781-98-2 | C24H22FNO3 |
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去异丙基丙卡特罗 | 5-(2-Amino-1-hydroxy-butyl)-8-hydroxy-1H-quinolin-2-one | 63483-95-4 | C13H16N2O3 |
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去异丁基环索奈德 | desisobutyryl ciclesonide | 161115-59-9 | C28H38O6 |
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去噻唑基甲氧羰基利托那韦 | N-ritonavir | 176655-55-3 | C32H45N5O3S |
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去噻唑基甲基 利托那韦 | (2S)-N-(((1S)-1-benzyl-2-((4S,5S)-4-benzyl-2-oxo-1,3-oxazolidin-5-yl)ethyl)-2-((((2-isopropyl-1,3-thiazol-4-yl)methyl)N-methyl-amino)carbonyl)amino)-3-methylbutanamide | 256328-82-2 | C33H43N5O4S |
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去克拉定糖阿奇霉素 | 3-O-descladinosylazithromycin | 117693-41-1 | C30H58N2O9 |
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去乙醇双嘧达莫 | Desethanol dipyridamole | 1176886-12-6 | C22H36N8O3 |
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去乙酰基碘克沙醇 | 5,5'-(N-acetyl-2-hydroxypropane-1,3-diyldiamino)bis<N,N'-bis(dihydroxypropyl)-2,4,6-triiodoisophthalamide> | 171897-74-8 | C33H42I6N6O14 |
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去乙酰基消旋卡多曲二硫醚 | Deacetyl Racecadotril Disulfide | 141437-88-9 | C38H40N2O6S2 |
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去乙酰基消旋卡多曲 | benzyl N-<2-(mercaptomethyl)-3-phenylpropanoyl>glycinate | 81110-69-2 | C19H21NO3S |
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去乙酰基头孢菌素C | deacetylcephalosporin C | 1476-46-6 | C14H19N3O7S |
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去乙烯诺氟沙星盐酸盐 | 7-(2-aminoethylamino)-1-ethyl-6-fluoro-1,4-dihydro-4-oxoquinoline-3-carboxylic acid | 75001-77-3 | C14H16FN3O3 |
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去乙烯基环丙沙星盐酸盐 | 7-((2-aminoethyl)amino)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid | 528851-31-2 | C15H16FN3O3*ClH |
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去乙基乙酸酯(E)-头孢呋辛酯 | cefuroxime | 97232-97-8 | C16H16N4O8S |
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去[2-[(2-羟基乙基)氨基]乙基]米托蒽醌 | 1-amino-5,8-dihydroxy-4-(2-(2-hydroxyethylamino)ethylamino)anthracene-9,10-dione | 89991-52-6 | C18H19N3O5 |
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去-6-[4-(2-羟基乙基)-1-哌嗪基]-6-氯达沙替尼 | 2-(6-chloro-2-methylpyrimidin-4-ylamino)-N-(2-chloro-6-(hydroxymethyl)phenyl)thiazole-5-carboxamide | 910297-71-1 | C16H13Cl2N5O2S |
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去-(N-2-吡啶基-beta-丙氨酸乙酯)达比加群酯5-乙基羧酸酯 | 2-[((4-[([(hexyloxy)carbonyl]amino)methanimidoyl]phenyl)amino)methyl]-1-methyl-1H-benzimidazole-5-carboxylic acid ethyl ester | 1408238-36-7 | C26H33N5O4 |
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去(甲基哌嗪基-N-甲基)伊马替尼二聚体 | 4-bis[4-[4-methyl-3-[[4-(pyridin-3-yl)pyrimidin-2-yl]amino]phenyl]carbamoyl]benzylpiperazine | 1365802-18-1 | C52H48N12O2 |
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去(三氟乙基)兰索拉唑硫醚 | demethoxypropylrabeprazole thioether | 131926-97-1 | C14H13N3OS |
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去(2,3-二羟基丙基)碘克沙醇 | 5-(Acetyl(3-(acetyl(3-carbamoyl-5-((2,3-dihydroxypropyl)carbamoyl)-2,4,6-triiodophenyl)amino)-2-hydroxypropyl)amino)-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide | 255376-57-9 | C32H38I6N6O13 |
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厄贝沙坦杂质19 | 2-cyano-4'-(azidomethyl)biphenyl | 133690-91-2 | C14H10N4 |
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厄洛替尼杂质M | 4-Methyl Erlotinib Hydrochloride | 1346601-52-2 | C23H25N3O4 |
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厄洛替尼杂质 | 6,7-Bis(2-methoxyethoxy)-N-(3-vinylphenyl)quinazolin-4-amine hydrochloride | 1624294-38-7 | C22H26ClN3O4 |
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厄洛替尼杂质 | N-(3-ethynylphenyl)-6,7-dihydroxy-4-quinazolinamine | 938185-06-9 | C16H11N3O2 |
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