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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特布他林杂质 | benzyl 3,5-bis(benzyloxy)benzoate | 50513-72-9 | C28H24O4 |
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特力利汀原料药 | (2S,4R)-Teneligliptin | 1404559-15-4 | C22H30N6OS |
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牡荆素2“-葡萄糖苷 | apigenin-8-C-β-D-glucopyranosyl-(1→2)-β-D-glucopyranoside | 61360-94-9 | C27H30O15 |
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牛磺猪去氧胆酸 | Taurohyodeoxycholic acid | 2958-04-5 | C26H45NO6S |
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烦宁杂质F | 7-chloro-2-methoxy-5-phenyl-3H-1,4-benzodiazepine | 31269-33-7 | C16H13ClN2O |
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溴酚肟 | bromofenoxim | 13181-17-4 | C13H7Br2N3O6 |
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溴莫尼定杂质H | 5-Chloro-6-(2-imidazolin-2-yl-amino)-quinoxaline | 91147-46-5 | C11H10ClN5 |
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溴莫尼定 | AGN 192076 | 151110-15-5 | C11H8BrN5 |
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溴苯扎隆 | (3-bromo-4-hydroxyphenyl)(2-ethylbenzofuran-3-yl)methanone | 94729-09-6 | C17H13BrO3 |
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溴甲纳曲酮杂质4 | (1R,9R,10S)-17-(cyclopropylmethyl)-3,10-dihydroxy-17-methyl-17-azoniatetracyclo[7.5.3.01,10.02,7]heptadeca-2,5,7-triene-4,13-dione;bromide | 1005410-32-1 | Br*C21H26NO4 |
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溴巴坦钠盐 | 6β-bromopenicillanic acid sodium salt | 73335-78-1 | C8H9BrNO3S*Na |
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溴巴坦S,S-二氧化物 | 6β-bromopenicillanic acid 1,1-dioxide | 75527-87-6 | C8H10BrNO5S |
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溴己新杂质D | N-methyl-N-cyclohexyl-2-amino-5-bromobenzylamine | 132004-28-5 | C14H21BrN2 |
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溴夫定杂质H | [125I]-(E)-5-(2-Iodovinyl)-2'-deoxyuridine | 69304-48-9 | C11H13IN2O5 |
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混旋樟脑磺酸 | camphor-10-sulfonic acid | 5872-08-2 | C10H16O4S |
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消旋卡多曲杂质D | Thiorphan Disulfide | 123658-06-0 | C24H28N2O6S2 |
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洛索洛芬钠杂质 | 1-methyl-2-oxocyclopentanecarboxylic acid | 50882-18-3 | C7H10O3 |
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洛索洛芬相关化合物3 | 2-(4-acetylbenzyl)cyclopentan-1-one | 96824-28-1 | C14H16O2 |
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洛索洛芬杂质18 | methyl 2-[4-(bromomethyl)phenyl]propanoate | 99807-54-2 | C11H13BrO2 |
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洛索洛芬杂质15 | 2-(4-((1-hydroxy-2-cyclopentanonyl)methyl)phenyl)propionic acid | 1091621-62-3 | C15H18O4 |
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洛沙坦杂质K | Losartan Impurity K | 1159977-26-0 | C21H20Cl2N6 |
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洋川芎内酯I | senkyunolide I | 94596-28-8 | C12H16O4 |
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泼尼松龙杂质A | 16β,21ξ-Epoxy-11β,21ξ-dihydroxy-1,4-pregnadien-3,20-dion | 77017-17-5 | C21H26O5 |
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泼尼松龙戊酸酯 | prednisolone 21-trimethylacetate | 1107-99-9 | C26H36O6 |
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泼尼松龙半琥珀酸酯 | prednisolone hemisuccinate | 2920-86-7 | C25H32O8 |
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泼尼松龙EP杂质E | Unii-MT32xmb69T | 95815-58-0 | C21H28O6 |
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泼尼松龙21-丙酸酯 | 11β,17-dihydroxy-21-propionyloxypregna-1,4-diene-3,20-dione | 5740-62-5 | C24H32O6 |
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泼尼松杂质D | pregna-1,4,9(11)-triene-17α,21-diol-3,20-dione | 10184-69-7 | C21H26O4 |
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泼尼卡松 | prednicarbate | 73771-04-7 | C27H36O8 |
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泰诺福韦单异丙氧羰基氧甲基酯 | ((((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(hydroxy)phosphoryl)oxy)methyl isopropyl carbonate | 211364-69-1 | C14H22N5O7P |
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泰地唑胺杂质35 | 2CZ2P66U2C | 1256966-02-5 | C34H29F2N12O8P |
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泮托拉唑钠倍半结晶水合物 | pantoprazole sodium sesquihydrate | 164579-32-2 | C16H14F2N3O4S*H2O*Na |
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泮托拉唑硫醚 | pantoprazole sulfide | 102625-64-9 | C16H15F2N3O3S |
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泮托拉唑砜N-氧化物 | 5-(difluoromethoxy)-2-[(3,4-dimethoxypyridin-2-yl-1-oxide)methylsulfonyl]-1H-benzoimidazole | 953787-55-8 | C16H15F2N3O6S |
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泮托拉唑相关物质A | Pantoprazole sulfone | 127780-16-9 | C16H15F2N3O5S |
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泮托拉唑氮-甲基混合物杂质 | N3-Methyl pantoprazole | 721924-06-7 | C17H17F2N3O4S |
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泮托拉唑杂质1 | 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)-chloromethyl]sulfinyl]-1H-benzimidazole | 812664-93-0 | C16H14ClF2N3O4S |
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泮托拉唑杂质 | 4-(difluoromethoxy)benzene-1,2-diamine | 172282-50-7 | C7H8F2N2O |
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泮托拉唑N-氧化钠盐 | Pantoprazole N-Oxide Sodium Salt | 1279822-90-0 | C16H15F2N3NaO5S |
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泮托拉唑N-氧化物 | pantoprazole N-oxide | 953787-60-5 | C16H15F2N3O5S |
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波生坦羟甲基杂质 | Ro 48-5033 | 253688-60-7 | C27H29N5O7S |
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N-[6-氯-5-(2-甲氧基苯氧基)[2,2'-二嘧啶]-4-基]-4-叔丁基苯磺酰胺 | 4-tert-butyl-N-(6-chloro-5-(2-methoxyphenoxy)2,2'-bipyrimidin-4-yl)benzene sulfonamide | 150727-06-3 | C25H24ClN5O4S |
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泛昔洛韦杂质12 | dimethyl 2-(2-(2-aminopurine-9-yl)ethyl)malonate | 122497-20-5 | C12H15N5O4 |
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泛昔洛韦USPRCB | (R,S)-9-<4-acetoxy-3-(hydroxymethyl)but-1-yl>-2-aminopurine | 104227-88-5 | C12H17N5O3 |
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法莫替丁相关化合物B | 3,5-bis<2-<<<2-<(diaminomethylene)amino>-4-thiazolyl>methyl>thio>ethyl>-4H-1,2,4,6-thiatriazine 1,1-dioxide | 89268-62-2 | C16H23N11O2S5 |
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法莫替丁相关化合物A盐酸盐 | 3-(((2-((Diaminomethylene)amino)thiazol-4-yl)methyl)thio)propanimidamide hydrochloride | 76833-47-1 | C8H15ClN6S2 |
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法舒地尔杂质6 | 5-isoquinolinesulfonic acid ethyl ester | 2044706-58-1 | C11H11NO3S |
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法舒地尔杂质5 | 5-isoquinolinesulfonic acid methyl ester | 2044702-91-0 | C10H9NO3S |
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法舒地尔二聚体 | 1,4-Bis(isoquinolin-5-ylsulfonyl)-1,4-diazepane | 1337967-93-7 | C23H22N4O4S2 |
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法罗培南杂质09 | 2-Thiazoleacetic acid, 2,5-dihydro-4-carboxy-5-(4-hydroxybutylidene)-alpha-(1-hydroxyethyl)-,disodium salt, (2R-(2R*(S*(R*)),5Z))- | 130609-10-8 | C12H15NNa2O6S |
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