药典标准品和杂质标准品
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 |
|---|---|---|---|---|
| 3-(2-氰基乙基-(2-羟基乙基)氨基)丙腈 | 3,3'-<(2-hydroxyethyl)imino>bispropionitrile | 6305-56-2 | C8H13N3O |
|
| 3-(2-氯乙基)八氢-2-羟基-1,3,6,2-氧杂二氮杂磷杂八环 2-氧化物 | 3-(2-Chloroethyl)octahydro-2-hydroxy-1,3,6,2-oxadiazaphosphonine 2-oxide | 158401-52-6 | C7H16ClN2O3P |
|
| 3-(2-氯-6-氟苯基)-5-甲基异恶唑-4-羧酸 | 3-(2-chloro-6-fluorophenyl)-5-methylisoxazole-4-carboxylic acid | 3919-74-2 | C11H7ClFNO3 |
|
| 3-(2-氨基-1-羟基乙基)苯-1,2-二醇 | 2,3-Dihydroxyphenethanolamin | 73660-93-2 | C8H11NO3 |
|
| 3-(1-萘基氧基)苯丙酮 | 3-naphthoxypropiophenone | 41198-42-9 | C19H16O2 |
|
| 3-(1-哌啶基)苯丙酮盐酸盐 | 1-phenyl-3-(piperidin-1-yl)propan-1-one | 73-63-2 | C14H19NO |
|
| 3-(1,4-二氢-5-甲基-4-氧代-7-丙基咪唑并[5,1-f][1,2,4]三嗪-2-基)-4-乙氧基苯磺酸 | 4-ethoxy-3-(5-methyl-4-oxo-7-propyl-3,4-dihydroimidazo[5,1-f][1,2,4]triazin-2-yl)benzenesulfonic acid | 437717-43-6 | C17H20N4O5S |
|
| 3,6-二氯吡嗪-2-甲酰胺 | 3,6-dichloropyrazine-2-carboxamide | 1023813-21-9 | C5H3Cl2N3O |
|
| 3,6-二氟-2-吡嗪甲酰胺 | 3,6-difluoropyrazine-2-carboxamide | 356783-29-4 | C5H3F2N3O |
|
| 3,5-双(溴甲基)吡啶 | 3,5-bis(bromomethyl)pyridine | 35991-75-4 | C7H7Br2N |
|
| 3,5-二氯-噻吩-2-羧酸 | 2,4-Dichlorthiophen-5-carbonsaeure | 89166-94-9 | C5H2Cl2O2S |
|
| 3,5-二氨基水杨酸 | 3,5-diaminosalicylic acid | 112725-89-0 | C7H8N2O3 |
|
| 3,5-二氨基-6-(2,4-二氯苯基)-1,2,4-三嗪 | 3,5-diamino-6-(2,4-dichlorophenyl)-1,2,4-triazine | 38943-76-9 | C9H7Cl2N5 |
|
| 3,5-二(苄氧基)苯甲酸乙酯 | ethyl 3,5-di(benzyloxy)benzoate | 50841-46-8 | C23H22O4 |
|
| 3,5-二(吡啶-4-基)-4H-1,2,4-三唑-4-胺 | 4-amino-3,5-bis(4-pyridyl)-1,2,4-triazole | 38634-05-8 | C12H10N6 |
|
| 3,5-二(4-吡啶基)-1H-1,2,4-三唑-1-胺 | 1-Amino-3,5-bis(4-pyridyl)-1H-1,2,4-triazole | 4923-06-2 | C12H10N6 |
|
| 3,5,7-三甲基金刚烷胺盐酸盐 | 3,5,7-trimethyladamantan-1-amine hydrochloride | 15210-60-3 | C13H23N*ClH |
|
| 3,5,6-三甲基-哌嗪-2-甲醛 | 3,5,6-trimethylpyrazine-2-carbaldehyde | 186534-02-1 | C8H10N2O |
|
| 3,4-双(环丙基甲氧基)-n-(3,5-二氯吡啶-4-基)苯甲酰胺 | 3,4-bis(cyclopropylmethoxy)-N-(3,5-dichloropyridin-4-yl) benzamide | 1391052-24-6 | C20H20Cl2N2O3 |
|
| 3,4-二羟基苯基丙酮酸 | 3,4-dihydroxyphenylpyruvic acid | 4228-66-4 | C9H8O5 |
|
| 3,4-二羟基苯乙酰胺 | 3,4-dihydroxyphenylacetamide | 1129-53-9 | C8H9NO3 |
|
| 3,4-二羟基丁酸 | 3,4-dihydroxybutyric acid | 1518-61-2 | C4H8O4 |
|
| 3,4-二甲氧基-N,N-二甲基苯乙胺盐酸盐 | N,N-dimethylhomoveratrylamine | 51012-67-0 | C12H19NO2*ClH |
|
| 3,4-二甲氧基-2-羟基苯甲醛 | 3,4-dimethoxysalicylaldehyde | 19283-70-6 | C9H10O4 |
|
| 3,4-二氢-7-(4-氯丁氧基)-2(1H)-喹啉酮 | 7-(4-chlorobutoxy)-3,4-dihydrocarbostyril | 120004-79-7 | C13H16ClNO2 |
|
| 3,4-二氢-2(1H)-吡啶酮 | 2-oxo-1,2,3,4-tetrahydropyridine | 57147-25-8 | C5H7NO |
|
| 3,4-O-(二乙基甲基亚基)莽草酸乙酯 | (3aR,7R,7aS)-ethyl 2,2-diethyl-7-hydroxy-3a,6,7,7a-tetrahydrobenzo[d][1,3]dioxole-5-carboxylate | 943515-58-0 | C14H22O5 |
|
| 3,4,5-三氯愈创木酚 | 3,4,5-trichloroguaiacol | 57057-83-7 | C7H5Cl3O2 |
|
| 3,3-二氯-1-(4-硝基苯基)-2-哌啶酮 | 3,3-dichloro-1-(4-nitrophenyl)piperidin-2-one | 881386-01-2 | C11H10Cl2N2O3 |
|
| 3,3,5,5-四碘甲腺乙酸 | tetrac | 67-30-1 | C14H8I4O4 |
|
| 3,3'-偶氮二邻苯二甲酸 | azobenzene-2,2',3,3'-tetracarboxylic acid | 88687-92-7 | C16H10N2O8 |
|
| 3,12-二氧代-5-beta-胆烷-24-酸 | 3,12-dioxo-7-deoxycholic acid | 2958-05-6 | C24H36O4 |
|
| 3(S)-氢过氧基辛伐他汀 | 3(S)-hydroperoxysimvastatin | 1092716-44-3 | C25H38O7 |
|
| 3(R)-氢过氧基辛伐他汀 | 3(R)-hydroperoxysimvastatin | 1092716-42-1 | C25H38O7 |
|
| 3'-[3-(3-叠氮基-2,3-二脱氧-β-D-赤型-呋喃呋喃糖基)-3,6-二氢-5-甲基-2,6-二氧代-1(2H)-嘧啶基]-3'-脱氧胸苷 | 3'-N''-(3'''-azido-3'''-deoxythymid-3''-yl)-3'-deoxythymidine | 148665-49-0 | C20H25N7O8 |
|
| 3'-N-去甲基-3'-N-甲酰基阿奇霉素 | 3'-N-demethyl-3'-N-formylazithromycin | 612069-28-0 | C38H70N2O13 |
|
| 3',4,6-三甲氧基-5'-甲基螺[1-苯并呋喃-2,4'-环己-2-烯]-1',3-二酮 | (2S,6'R)-2',4,6-trimethoxy-6'-methyl-3H-spiro[benzofuran-2,1'-cyclohexan]-2'-ene-3,4'-dione | 3680-32-8 | C17H18O6 |
|
| 3',4'-二甲氧基异苯丁酮 | 3,4-dimethoxyphenyl isopropyl ketone | 14046-55-0 | C12H16O3 |
|
| 2’-氰基-4-甲醛基联苯 | 4-(2-Cyanophenyl)benzaldehyde | 135689-93-9 | C14H9NO |
|
| 2’-去氯-2’-羟基达沙替尼 | N-(2-Hydroxy-6-methylphenyl)-2-((6-(4-(2-hydroxyethyl)piperazin-1-yl)-2-methylpyrimidin-4-yl)amino)thiazole-5-carboxamide | 1159977-25-9 | C22H27N7O3S |
|
| 2’,4’-二羟查耳酮 | 2',4'-dihydroxychalcone | 1776-30-3 | C15H12O3 |
|
| 2a,3a,16a,17a-双环氧雄甾-17b-羟基 5a-醋酸酯 | 2α,3α:16α,17α-diepoxy-17β-acetoxy-5α-androstane | 50588-22-2 | C21H30O4 |
|
| 2H-3-苯并吖庚英-2-酮,3-[3-[[[(7R)-3,4-二甲氧基二环[4.2.0]辛-1,3,5-三烯-7-基]甲基]甲基氨基]丙基]-1,3,4,5-四氢-7,8-二甲氧基- | 3-[3-[[[(7R)-3,4-dimethoxybicyclo[4.2.0]octane-1,3,5-trien-7-yl]methyl]methylamino]propyl]-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepine-2-one | 167072-91-5 | C27H36N2O5 |
|
| 2H-2-乙基坎地沙坦西来替昔酯 | (1RS)-1-[[(cyclohexyloxy)carbonyl]oxy]ethyl 2-ethoxy-1-[[2'-(2-ethyl-2H-tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-benzimidazole-7-carboxylate | 914613-36-8 | C35H38N6O6 |
|
| 2H,5H-吡喃并[4,3-b]吡喃基莫匹罗星钠 | Sodium; 9-{(E)-4-[(2R,3S,4aS,7S,8S,8aR)-3,8-dihydroxy-2-((1S,2S)-2-hydroxy-1-methyl-propyl)-hexahydro-pyrano[4,3-b]pyran-7-yl]-3-methyl-but-2-enoyloxy}-nonanoate | 116182-44-6 | C26H43O9*Na |
|
| 2??(4-吗啉基)-16-(1-吡咯基)-雄甾-3,17-二醇二乙酸酯 | (2β,3α,5α,16β,17β)-2-(4-morpholinyl)-16-(1-pyrrolidinyl)-3,17-bis(acetyloxyoxy)androstane | 119302-22-6 | C31H50N2O5 |
|
| 25-乙酰-3-[(五)-[(4-甲基-1-哌嗪基)亚胺]甲基]利福霉素 | Desacetylrifampicin | 16783-99-6 | C41H56N4O11 |
|
| 24R-卡泊三醇 | 20(R)-(3'(R)-cyclopropyl-3'-hydroxyprop-1'(E)-enyl)-1(S),3(R)-dihydroxy-9,10-secopregna-5(Z),7(E),10(19)-triene | 112827-99-3 | C27H40O3 |
|
| 21-脱氢-6α-甲基泼尼松龙 | 11β,17α-dihydroxy-3,20-dioxo-6α-methyl-1,4-pregnadien-21-al | 58636-50-3 | C22H28O5 |
|
| 21-二羟基-16&alpha-甲基孕甾-1,4,9(11)-三烯-3,20-二酮-21-醋酸酯 | 17α,21-dihydroxy-16α-methyl-1,4,9(11)-pregnatriene-3,20-dione 21-acetate | 10106-41-9 | C24H30O5 |
|
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