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 |
|---|---|---|---|---|
| 4-[2-[二(三氘甲基)氨基]-1-(1-羟基环己基)乙基]苯酚 | desmethylvenlafaxine-d6 | 1062605-69-9 | C16H25NO2 |
|
| 4-[2-[[(环己基氨基)羰基]氨基]乙基]苯磺酰胺 | 4-(2-((Cyclohexylcarbamoyl)amino)ethyl)benzenesulfonamide | 10080-05-4 | C15H23N3O3S |
|
| 4-[2-(环丙基甲氧基)乙基]苯酚 | 4-[2-(cyclopropylmethoxy)-ethyl]-phenol | 63659-16-5 | C12H16O2 |
|
| 4-[2-(二甲氨基)-1-(1-羟基环己基)乙基]-2-({[2-(1-羟基环己基)-2-(4-羟基苯基)乙基](甲基)氨基}甲基)苯酚 | 4-[2-(dimethylamino)-1-(1-hydroxycyclohexyl)ethyl]-2-({[2-(1-hydroxycyclohexyl)-2-(4-hydroxyphenyl)ethyl](methyl)amino}methyl)phenol | 1187545-61-4 | C32H48N2O4 |
|
| 4-[2-(二丙基氨基)乙基]-1H-吲哚-2,3-二酮单盐酸盐 | SKF-96266 hydrochloride | 221264-21-7 | C16H23ClN2O2 |
|
| 4-[1-[4-(氨基磺酰基)苯基]-3-(三氟甲基)-1H-吡唑-5-基]苯甲酸 | Carboxy-Celecoxib | 170571-01-4 | C17H12F3N3O4S |
|
| 4-[1-(1-羟基环己基)-2-(甲基氨基)乙基]苯酚 | N-Desmethyldesvenlafaxine | 135308-74-6 | C15H23NO2 |
|
| 4-[(3S,5R,8R,9S,10S,12R,13S,14S,17R)-3-[(2R,4S,5S,6R)-4,5-二羟基-6-甲基四氢吡喃-2-基]氧基-12,14-二羟基-10,13-二甲基-1,2,3,4,5,6,7,8,9,11,12,15,16,17-十四氢环戊烯并[a]菲-17-基]-5H-呋喃-2-酮 | Digoxigenin mono-digitoside | 5352-63-6 | C29H44O8 |
|
| 4-[(3-氯-4-氟苯基)氨基]-6-[3-(4-吗啉基)丙氧基]-7-羟基喹唑啉 | 4-((3-chloro-4-fluorophenyl)amino)-6-(3-morpholinopropoxy)quinazolin-7-ol | 847949-49-9 | C21H22ClFN4O3 |
|
| 4-[(2S,3R,4S,5S,6R)-3,4,5-三羟基-6-(羟基甲基)四氢吡喃-2-基]氧基呋喃并[3,2-g]苯并吡喃-7-酮 | bergaptol-O-β-D-glucopyranoside | 131623-13-7 | C17H16O9 |
|
| 4-[(2,3-二氢-5,6-二甲氧基-1H-茚-2-基)甲基]哌啶盐酸盐 | 5,6-dimethoxy-2-[(4-piperidinyl)methyl]indane hydrochloride | 1034439-43-4 | C17H25NO2*ClH |
|
| 4-[(2,3,4-三甲氧基苯基)甲基]-1-哌嗪羧酸乙酯 | Ethyl 4-(2,3,4-trimethoxybenzyl)piperazine-1-carboxylate | 53531-01-4 | C17H26N2O5 |
|
| 4-[(1S)-2-(叔丁基氨基)-1-羟基乙基]-2-(羟基甲基)苯酚 | (+)-Albuterol | 34271-50-6 | C13H21NO3 |
|
| 4-[(1S)-2-(二甲基氨基)-1-(1-羟基环己基)乙基]苯酚 | (S)-O-desmethylvenlafaxine | 142761-12-4 | C16H25NO2 |
|
| 4-[(1R)-2-(二甲基氨基)-1-(1-羟基环己基)乙基]-苯酚 | (R)-4-(2-(dimethylamino)-1-(1-hydroxycyclohexyl)ethyl)phenol | 142761-11-3 | C16H25NO2 |
|
| 4-O-羧甲基-21-脱氧-20-羟基-21-氧代利福霉素 | 2-[[(9Z,19Z,21Z)-13-Acetyloxy-2,15,18,29-tetrahydroxy-11-methoxy-3,7,12,14,16,18,22-heptamethyl-6,17,23-trioxo-8,30-dioxa-24-azatetracyclo[23.3.1.14,7.05,28]triaconta-1(29),2,4,9,19,21,25,27-octaen-27-yl]oxy]acetic acid | 15271-73-5 | C39H47NO15 |
|
| 4-O-甲基卡比多巴 | (2S)-2-Hydrazino-3-(3-hydroxy-4-methoxyphenyl)-2-methylpropanoic acid | 1361017-74-4 | C11H16N2O4 |
|
| 4-O-去甲基4-O-乙基甲氧苄啶 | 2,4-diamino-5-(3,5-dimethoxy-4-ethoxybenzyl)pyrimidine | 78025-68-0 | C15H20N4O3 |
|
| 4-O-beta-吡喃半乳糖基-D-吡喃甘露糖 | epilactose | 50468-56-9 | C12H22O11 |
|
| 4-N-脱乙酰基-5-N-乙酰基奥塞米韦 | ethyl-(3R,4R,5S)-5-(acetylamino)-4-amino-3-(pentan-3-yloxy)cyclohex-1-ene-1-carboxylate | 956267-10-0 | C16H28N2O4 |
|
| 4-(苄氧基)-alpha-[[叔丁基氨基]甲基]-间二甲苯-alpha,alpha'-二醇 | O-benzyl salbutamol | 56796-66-8 | C20H27NO3 |
|
| 4-(苄氧基)-2-甲基-1H-苯并[D]咪唑-6-羧酸 | 2-methyl-4-[(phenylmethyl)oxy]-1H-benzimidazole-6-carboxylic acid | 942195-83-7 | C16H14N2O3 |
|
| 4-(羟基甲基)-[1,1-联苯]-2-羧酸 | 4'-(hydroxymethyl)-[1,1'-biphenyl]-2-carboxylic acid | 158144-54-8 | C14H12O3 |
|
| 4-(羟基氨基)苯酚 | 4-hydroxyphenylhydroxylamine | 3505-87-1 | C6H7NO2 |
|
| 4-(环氧乙烷甲氧基)-苯丙酸甲酯 | methyl 3-[4-(oxiran-2-ylmethoxy)phenyl]propanoate | 81147-94-6 | C13H16O4 |
|
| 4-(环氧乙基甲氧基)苯乙酰胺 | (S)-1-[p-(carbamoylmethyl)phenoxy]-2,3-epoxypropane | 29122-69-8 | C11H13NO3 |
|
| 4-(溴甲基)-[1,1-联苯]-2-羧酸 | 4'-bromomethylbiphenyl-2-carboxylic acid | 150766-86-2 | C14H11BrO2 |
|
| 4-(氯甲基)苯甲基醇 | 4-(hydroxymethyl)benzyl chloride | 16473-35-1 | C8H9ClO |
|
| 4-(二苯甲氧基)哌啶 | 4-diphenylmethoxypiperidine | 58258-01-8 | C18H21NO |
|
| 4-(二氯甲基)苯甲腈 | 1-(dichloromethyl)-4-cyanobenzene | 74231-65-5 | C8H5Cl2N |
|
| 4-(二乙基氨基)-2-丁炔-1-醇二苯基乙醇酸酯 | 4-Diaethylamino-2-butinylbenzilat | 14943-53-4 | C22H25NO3 |
|
| 4-({3-[2-(二甲基硝基r基)乙基]-1H-吲哚-5-基}甲基)-1,3-恶唑烷-2-酮 | N,N-dimethyl-2-[5-[(2-oxo-1,3-oxazolidin-4-yl)methyl]-1H-indol-3-yl]ethanamine Oxide | 251451-30-6 | C16H21N3O3 |
|
| 4-(8-氯-6,11-二氢-11-羟基-5H-苯并[5,6]环庚并[1,2-B]吡啶-11-基)-1-哌啶羧酸乙酯 | 11-Hydroxy Dihydro Loratadine | 133284-74-9 | C22H25ClN2O3 |
|
| 4-(6-溴吡啶-3-基)哌嗪-1-羧酸叔丁酯 | tert-butyl 4-(6-bromopyridin-3-yl)piperazine-1-carboxylate | 412348-27-7 | C14H20BrN3O2 |
|
| 4-(5-氯-2-噻吩)-1,3-噻唑-2-胺 | 4-(5-chloro-thien-2-yl)-1,3-thiazol-2-amine | 123971-45-9 | C7H5ClN2S2 |
|
| 4-(4-硝基吡啶-3-基)哌嗪-1-甲酸叔丁酯 | tert-Butyl 4-(4-nitropyridin-3-yl)piperazine-1-carboxylate | 1774898-55-3 | C14H20N4O4 |
|
| 4-(4-甲基-1-哌嗪基甲基)苯甲酸 | 4-(4-methylpiperazin-1-ylmethyl)benzoic acid | 106261-48-7 | C13H18N2O2 |
|
| 4-(4-溴噻吩-2-基)噻唑-2-胺 | 2-amino-4-(4-bromo-2-thienyl)thiazole | 81216-89-9 | C7H5BrN2S2 |
|
| 4-(4-溴-3-甲酰基苯氧基)苯甲腈 | 4-(4-bromo-3-formylphenoxy)benzonitrile | 906673-54-9 | C14H8BrNO2 |
|
| 4-(4-氯苯基)-2-吡咯烷酮 | 4-(4-chlorophenyl)pyrrolidin-2-one | 22518-27-0 | C10H10ClNO |
|
| 4-(4-氯苯基)-1-[4-(4-氟苯基)-4-氧丁基]-4-哌啶癸酸盐 | Haloperidol decanoate | 74050-97-8 | C31H41ClFNO3 |
|
| 4-(4-氯苄基)-1-(2H)-酞嗪酮 | 4-(4-chlorobenzyl)phthalazin-1(2H)-one | 53242-88-9 | C15H11ClN2O |
|
| 4-(4-氨基苯氧基)-6-甲氧基喹啉-7-酚 | 4-(4-aminophenoxy)-6-methoxyquinolin-7-ol | 1355031-15-0 | C16H14N2O3 |
|
| 4-(4-氨基-3-氟苯氧基)-N-甲基吡啶-2-甲酰胺 | 4-(4-amino-3-fluorophenoxy)-N-methylpicolinamide | 757251-39-1 | C13H12FN3O2 |
|
| 4-(4-氟苯甲酰基)-3-羟甲基 苯甲氰 | 4-(4-fluorobenzoyl)-3-(hydroxymethyl)benzonitrile | 260371-16-2 | C15H10FNO2 |
|
| 4-(4-氟苯基)-6-(1-甲基乙基)-N,2-二苯基-5-[2-(四氢-4-羟基-6-氧代-2H-吡喃-2-基)乙基]-3,7-二氧杂-5-氮杂三环[4.1.0.0(2,4)]庚烷-1-甲酰胺 | Atorvastatin lactone diepoxide | 1046118-40-4 | C33H33FN2O6 |
|
| 4-(4-氟苯基)-1-甲基-2,6-二氧代哌啶-3-羧酸乙酯 | ethyl 4-(4-fluorophenyl)-1-methyl-2,6-dioxopiperidine-3-carboxylate | 202534-94-9 | C15H16FNO4 |
|
| 4-(4-氟苯基)-1,2,3,6-四氢-1-甲基吡啶盐酸盐 | 4-(4-Fluorophenyl)-1-methyl-1,2,3,6-tetrahydropyridine Hydrochloride | 1012886-75-7 | C12H14FN*ClH |
|
| 4-(3-甲基苯基)-2H-吡啶并[4,3-e][1,2,4]噻二嗪-3(4H)-酮1,1-二氧化物 | 4-m-Tolyl-2H-pyrido(4,3-E)(1,2,4)thiadiazin-3(4H)-one 1,1-dioxide | 72810-61-8 | C13H11N3O3S |
|
| 4-(3-溴丙基)吗啉氢溴酸 | 4-(3-Bromopropyl)morpholine hydrobromide | 88806-06-8 | C7H15Br2NO |
|
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