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-氯-6-(2-氯乙氧基)-7-(2-甲氧基乙氧基)喹唑啉 | 4-chloro-6-(2-chloroethoxy)-7-(2-methoxyethoxy)quinazoline | 183322-19-2 | C13H14Cl2N2O3 |
|
| 4-氯-6,7-双(2-氯乙氧基)喹唑啉 | 4-chloro-6,7-bis-(2-chloro-ethoxy)-quinazoline | 183322-21-6 | C12H11Cl3N2O2 |
|
| 4-氯-5-氨磺酰邻氨基苯甲酸 | 4-chloro-5-sulfamoylanthranilic acid | 3086-91-7 | C7H7ClN2O4S |
|
| 4-氯-3-羟基丁腈 | 4-chloro-3-hydroxybutyronitrile | 105-33-9 | C4H6ClNO |
|
| 4-氯-3-硝基-5-磺基苯甲酸 | 4-Chloro-3-nitro-5-sulfobenzoic acid | 130262-91-8 | C7H4ClNO7S |
|
| 4-氯-3-氰基-6-甲氧基-7-[3-(4-甲基哌嗪-1-基)丙氧基]喹啉 | 7-[3-(4-methylpiperazin-1-yl)propoxy]-6-methoxy-4-chloro-quinoline-3-carbonitrile | 492444-39-0 | C19H23ClN4O2 |
|
| 4-氯-3-氯磺酰基苯甲酰氯 | 3-chlorosulfonyl-4-chlorobenzoyl chloride | 62574-66-7 | C7H3Cl3O3S |
|
| 4-氯-2-(氯甲基)-3,5-二甲基吡啶盐酸盐(1:1) | 4-Chloro-2-chloromethyl-3,5-dimethylpyridine | 142885-96-9 | C8H9Cl2N |
|
| 4-氨基-N-[(1-乙基-2-吡咯烷基)甲基]-5-碘-2-甲氧基苯甲酰胺 | Amisulpride EP impurity C | 176849-91-5 | C15H22IN3O2 |
|
| 4-氨基-N-[(1-乙基-2-吡咯烷基)甲基]-2-甲氧基-5-(甲基磺酰基)苯甲酰胺 | N-(1-ethyl 2-pyrrolidylmethyl) 2-methoxy 4-amino 5-methylsulphonyl benzamide | 71676-00-1 | C16H25N3O4S |
|
| 4-氨基-N-(1-乙基-3-哌啶基)-5-(乙基磺酰基)-2-甲氧基苯甲酰胺 | 4-Amino-N-(1-ethyl-3-piperidinyl)-5-(ethylsulfonyl)-2-methoxybenzamide | 148516-68-1 | C17H27N3O4S |
|
| 4-氨基-5-氯-2-乙氧基-N-(吗啉-2-基甲基)苯甲酰胺 | 4-amino-5-chloro-2-ethoxy-N-(morpholin-2-ylmethyl)benzamide | 152013-26-8 | C14H20ClN3O3 |
|
| 4-氨基-5-氯-2,3-二氢-N-4-哌啶基-7-苯并呋喃甲酰胺 | 4-amino-5-chloro-2,3-dihydro-N-(4-piperidinyl)benzofuran-7-carboxamide | 137211-64-4 | C14H18ClN3O2 |
|
| 4-氨基-5-氯-2,1,3-苯并噻二唑 | 4-amino-5-chloro-2,1,3-benzothiadiazole | 30536-19-7 | C6H4ClN3S |
|
| 4-氨基-5-咪唑甲酰胺 | 5-Aminoimidazole-4-carboxamide | 360-97-4 | C4H6N4O |
|
| 4-氨基-5-[(3,4,5-三甲氧基苯基)甲基]-2(1H)-嘧啶酮 | 4-amino-2-hydroxy-5-(3,4,5-trimethoxybenzyl)pyrimidine | 60729-91-1 | C14H17N3O4 |
|
| 4-氨基-3,5-二氯苯甲醛 | 4-Amino-3,5-dichlorobenzaldehyde | 62909-66-4 | C7H5Cl2NO |
|
| 4-氨基-1-甲基-5-丙基-1H-吡唑-3-羧酸酰胺 | 4-amino-1-methyl-5-propyl-3-pyrazolecarboxamide | 247583-78-4 | C8H14N4O |
|
| 4-氧代伊布利特 | N-<4-<4-(ethyl-n-heptylamino)-1-hydroxy-4-oxo-butyl>phenyl>methanesulfonamide | 160087-98-9 | C20H34N2O4S |
|
| 4-氟-2-甲基苯甲酰胺 | 4-fluoro-2-methylbenzamide | 886501-45-7 | C8H8FNO |
|
| 4-哌啶丁醇 | 4-(piperidin-4-yl)butan-1-ol | 57614-92-3 | C9H19NO |
|
| 4-吡啶甲亚胺酸肼 | (Z)-N-aminopyridine-4-carboximidamide | 89830-71-7 | C6H8N4 |
|
| 4-吡啶丁酸 | 4-(pyridin-4-yl)butyric acid | 102878-73-9 | C9H11NO2 |
|
| 4-吗啉-4-基-1,2,5-三唑-3-酮 | 3-hydroxy-4-(N-morpholino)-1,2,5-thiadiazole | 30165-97-0 | C6H9N3O2S |
|
| 4-叔-丁基-2,6-二甲基-3-羟基苯基乙酸 | 4-t-butyl-2,6-dimethyl-3-hydroxyphenyl acetic acid | 55699-12-2 | C14H20O3 |
|
| 4-二氟甲氧基乙酰苯胺 | N-[4-(difluoromethoxy)phenyl]-acetamide | 22236-11-9 | C9H9F2NO2 |
|
| 4-乙酰氧基间苯二甲酸 | 4-(acetoxy)isophthalic acid | 5985-26-2 | C10H8O6 |
|
| 4-乙酰基大黄酸 | 4-Acetyl Rhein | 875535-36-7 | C17H10O7 |
|
| 4-乙酰基-2-氟联苯 | 3'-fluoro-4'-phenylacetophenone | 42771-79-9 | C14H11FO |
|
| 4-乙烯基-1,3-二氢-2H-吲哚-2-酮 | 4-vinyloxindole | 120427-93-2 | C10H9NO |
|
| 4-乙氧羰基-3-乙氧基苯乙酸 | 3-ethoxy-4-ethoxycarbonylphenylacetic acid | 99469-99-5 | C13H16O5 |
|
| 4-乙氧基-3-(4-吡啶基)-3-丁烯-2-酮 | 2-ethoxy-1-(pyridin-4-yl)vinyl methyl ketone | 88349-61-5 | C11H13NO2 |
|
| 4-丁基-4-(羟甲基)-1,2-二苯基-3,5-吡唑烷二酮丁二酸单酯 | Suxibuzone | 27470-51-5 | C24H26N2O6 |
|
| 4-[甲基[(3S)-3-(1-萘基氧基)-3-(2-噻吩基)丙基]氨基]-4-氧代丁酸 | duloxetine succinamide | 199191-66-7 | C22H23NO4S |
|
| 4-[甲基[(2-氨基-4-羟基蝶啶)-6-基甲基]氨基]苯甲酸 | 10-methyl-pteroic acid | 5623-18-7 | C15H14N6O3 |
|
| 4-[[4-(乙酰氧基)苯基]-2-吡啶基甲基]苯酚 | Monoacetyl bisacodyl | 72901-16-7 | C20H17NO3 |
|
| 4-[[3-异丙基-2-氧代-5-恶唑烷基]甲氧基]苯甲醛 | (±)4‑((3‑isopropyl‑2‑oxooxazolidin‑5‑yl)methoxy)benzaldehyde | 1173203-26-3 | C14H17NO4 |
|
| 4-[[3-[2-(3-氯苯基)乙基]-2-吡啶基]羰基]-1-哌啶羧酸乙酯 | 4-[[3-[2-(3-Chlorophenyl)ethyl]-2-pyridinyl]carbonyl]-1-piperidinecarboxylic acid | 107256-32-6 | C22H25ClN2O3 |
|
| 4-[[3-(4-甲基苯基)-3-氧代-1-(三氟甲基)亚丙基]氨基]苯磺酰胺 | 4-[[3-(4-Methylphenyl)-3-oxo-1-(trifluoromethyl)propylidene]amino]benzenesulfonamide | 1061214-09-2 | C17H15F3N2O3S |
|
| 4-[[(6S,8S,9S,10R,11S,13S,14S,17R)-11-羟基-17-(2-羟基乙酰基)-6,10,13-三甲基-3-氧代-7,8,9,11,12,14,15,16-八氢-6H-环戊并[a]菲-17-基]氧基]-4-氧代丁酸 | 6α-methylprednisolone 17-hemisuccinate | 77074-42-1 | C26H34O8 |
|
| 4-[N-(2,4-二氨基-6-蝶啶甲基)-N-甲氨基]苯甲酸半盐酸盐n水 | 4-[(2,4-diaminopteridin-6-ylmethyl)methylamino]benzoic acid | 19741-14-1 | C15H15N7O2 |
|
| 4-[6-[(6-溴-8-环戊基-7,8-二氢-5-甲基-7-氧代吡啶并[2,3-d]嘧啶-2-基)氨基]-3-吡啶基]-1-哌嗪羧酸叔丁酯 | 4-[6-(6-bromo-8-cyclopentyl-5-methyl-7-oxo-7,8-dihydropyrido[2,3-d]pyrimidin-2-ylamino)pyridin-3-yl]piperazine-1-carboxylic acid tert-butyl ester | 571188-82-4 | C27H34BrN7O3 |
|
| 4-[5-(4-羟基甲基苯基)-3-(三氟甲基)-1H-吡唑-1-基]苯磺酰胺 | Methylhydroxy-Celecoxib | 170571-00-3 | C17H14F3N3O3S |
|
| 4-[5-(3-甲基苯基)-3-三氟甲基-1H-吡唑-1-基]苯磺酰胺 | 4-(5-(m-tolyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide | 170570-01-1 | C17H14F3N3O2S |
|
| 4-[4-[4-(二苯基亚甲基)-1-哌啶基]-1-羟基丁基]-α,α-二甲基-苯乙酸 | 4-[4-[4-(diphenylmethylene)-1-piperidinyl]-1-hydroxybutyl]-α,α-dimethylbenzeneacetic acid | 1187954-57-9 | C32H37NO3 |
|
| 4-[4-(4-氯苯基)-4-羟基-1-哌啶基]-1-[4-[4-(4-氯苯基)-4-羟基-1-哌啶基]苯基]-1-丁酮 | 4-[4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl]-1-[4-[4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl]phenyl]butan-1-one | 67987-08-0 | C32H36Cl2N2O3 |
|
| 4-[3-(甲氨基)-1-(2-噻吩)丙基]-1-萘酚氢溴酸 | (+/-)-N-methyl-3-(2-thienyl)-3-(4-hydroxy-naphthyl)-propylamine hydrogenbromide | 949096-01-9 | BrH*C18H19NOS |
|
| 4-[2-羟基-3-[异丙基氨基]丙氧基]苯甲醇 | Des(isopropoxyethyl) Bisoprolol | 62572-93-4 | C13H21NO3 |
|
| 4-[2-羟基-3-[(1-甲基乙基)氨基]丙氧基]苯乙腈 | 1-(4'-cyanomethylphenoxy)-2-hydroxy-3-(isopropylamino)propane | 29277-73-4 | C14H20N2O2 |
|
| 4-[2-氟-5-[(4-氧代-3,4-二氢酞嗪-1-基)甲基]苯甲酰基]哌嗪-1-羧酸叔丁酯 | tert-butyl 4-(2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzoyl)piperazine-1-carboxylate | 763114-04-1 | C25H27FN4O4 |
|
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