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-(3-溴丙基)吗啉 | 4-(3-bromopropyl)morpholine | 125422-83-5 | C7H14BrNO |
|
| 4-(3-氨基-苯基)-吗啉-3-酮 | 4-(3-aminophenyl)morpholin-3-one | 1082495-22-4 | C10H12N2O2 |
|
| 4-(3-(哌啶-1-基)丙氧基)苯甲酸 | 4-(3-(piperidin-1-yl)propoxy)benzoic acid | 767286-87-3 | C15H21NO3 |
|
| 4-(3,4-二氯苯基)-N-甲基-3,4-二氢-2H-萘-1-亚胺氧化物 | N-[4-(3,4-dichlorophenyl)-3,4-dihydro-1(2H)-naphthalenylidene]methanamine N-oxide | 209473-00-7 | C17H15Cl2NO |
|
| 4-(3,4-二氯苯)-3,4-二氢-2H-萘-1-酮 | (4S)-4-(3,4-dichlorophenyl)-1-tetralone | 124379-29-9 | C16H12Cl2O |
|
| 4-(2-硝基苯基)吗啉-3-酮 | 4-(2-Nitrophenyl)morpholin-3-one | 845729-41-1 | C10H10N2O4 |
|
| 4-(2-甲基丙基)苯乙醇 | 1-(4-Isobutylphenyl)ethanol | 36039-35-7 | C12H18O |
|
| 4-(2-甲基-1-吡咯烷基)-7-氯喹啉 | 4-(2-methyl-1-pyrrolidyl)-7-chloroquinoline | 6281-58-9 | C14H15ClN2 |
|
| 4-(2-氰基苯基)苄醇 | 4'-(hydroxymethyl)-[1,1'-biphenyl]-2-carbonitrile | 154709-19-0 | C14H11NO |
|
| 4-(2-乙氧基-苯甲酰基氨基)-2-甲基-5-丙基-2H-吡唑-3-羧酸酰胺 | 4-[(2-ethoxybenzoyl)amino]-1-methyl-3-propyl-1H-pyrazole-5-carboxamide | 139756-03-9 | C17H22N4O3 |
|
| 4-(2,3-二甲基苄基)-1H-咪唑盐酸盐水合物 | detomidine hydrochloride monohydrate | 90038-00-9 | C12H14N2*ClH*H2O |
|
| 4-(2,3-二氯苯基)-2,6-二甲基-1,4-二氢吡啶-3,5-二羧酸二甲酯 | 4-(-2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylic acid methyl ester | 91189-59-2 | C17H17Cl2NO4 |
|
| 4-(2,3-二氯苯基)-2,6-二甲基-1,4-二氢吡啶-3,5-二羧酸 | 4-(2,3-Dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylic acid | 138279-32-0 | C15H13Cl2NO4 |
|
| 4-(1,3-苯并二氧戊环-5-基)-6,7-二甲氧基-9-[(2S,3R,4S,5S,6R)-3,4,5-三羟基-6-(羟基甲基)四氢吡喃-2-基]氧基-1H-苯并[f][2]苯并呋喃-3-酮 | 4-O-(β-D-glucopyranosyl)diphyllin | 30021-77-3 | C27H26O12 |
|
| 4-((4-(4-羟基二苯甲基)-1-哌啶基)-1-氧代丁基)-a,a-二甲基苯乙酸 | 4-[4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-1-oxobutyl]-α,α-dimethylbenzeneacetic acid | 76811-98-8 | C32H37NO4 |
|
| 4-((4,7,7-三甲基-3-氧代-双环(2.2.2)庚-2-亚基)甲基)苯磺酸 | benzylidene camphor sulfonic acid | 56039-58-8 | C17H20O4S |
|
| 4,6-二氯-2-二甲氨基-1,3,5-均三嗪 | 2-dimethylamino-4,6-dichloro-1,3,5-triazine | 2401-64-1 | C5H6Cl2N4 |
|
| 4,5-二溴苯-1,2-二醇 | 4,5-dibromobenzene-1,2-diol | 2563-26-0 | C6H4Br2O2 |
|
| 4,5-二氯噻吩-2-甲酸 | 4,5-dichlorothiophene-2-carboxylic acid | 31166-29-7 | C5H2Cl2O2S |
|
| 4,5-二氢-2-(1-萘基甲基)-1H-咪唑鎓硝酸盐 | Naphazoline nitrate | 5144-52-5 | C14H14N2*HNO3 |
|
| 4,5-二(2-甲氧基乙氧基)-2-硝基苯甲酸乙酯 | ethyl 4,5-bis(2-methoxyethoxy)-2-nitrobenzoate | 179688-26-7 | C15H21NO8 |
|
| 4,4’-联苯醌 | diphenoquinone | 494-72-4 | C12H8O2 |
|
| 4,4’-(4H-1,2,4-三唑-4-基亚甲基)双苯腈 | 4-[α-(4-cyano-phenyl)-1-(1,3,4-triazol-1-yl)-methyl]-benzonitrile | 112809-52-6 | C17H11N5 |
|
| 4,4’-(2-吡啶甲基)双酚 | 4,4'-(2-pyridylmethylene)diphenol | 603-41-8 | C18H15NO2 |
|
| 4,4’,4’’-亚甲基三苯甲腈 | 4,4',4''-tricyanotriphenylmethane | 113402-31-6 | C22H13N3 |
|
| 4,4,4-三氟-1-(间甲苯)丁烷-1,3-二酮 | 4,4,4-trifluoro-1-(3-methylphenyl)butane-1,3-dione | 53764-99-1 | C11H9F3O2 |
|
| 4,4,4-三氟-1-(邻甲苯)丁烷-1,3-二酮 | 4,4,4-trifluoro-1-(2-methylphenyl) butane-1,3-dione | 163266-02-2 | C11H9F3O2 |
|
| 4,4'-亚氨基二苯酚 | 4,4'-dihydroxydiphenylamine | 1752-24-5 | C12H11NO2 |
|
| 4,4'-[(2-羟基-1,3-丙烷二基)二(氧基)]二-苯乙酰胺 | Atenolol EP impurity E | 141650-31-9 | C19H22N2O5 |
|
| 4,4'-(丙烷-1,3-二基)二吗啉 | 1,3-bis-morpholinopropane | 48152-09-6 | C11H22N2O2 |
|
| 4,4''-二甲氧基氧化偶氮苯 | bis(4-methoxyphenyl)diazene | 501-58-6 | C14H14N2O2 |
|
| 4,11-二乙基-4,9-二羟基-1H-吡喃并[3',4':6,7]吲哚嗪并[1,2-b]喹啉-3,14(4H,12H)-二酮 | 7-ethyl-10-hydroxyl-camptothecin | 647852-82-2 | C22H20N2O5 |
|
| 4'-表恩替卡韦 | 2-Amino-1,9-dihydro-9-((1S,3R,4R)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl)-6H-purin-6-one | 1367369-80-9 | C12H15N5O3 |
|
| 4'-羟基阿莫西汀β-D-葡糖醛酸 | 4-Hydroxyatomoxetine-O-glucuronide | 540729-08-6 | C23H29NO8 |
|
| 4'-羟基氟比洛芬 | 2-(2-fluoro-4'-hydroxy-biphenyl-4-yl)-propionic acid | 52807-12-2 | C15H13FO3 |
|
| 4'-[(1,4'-二甲基-2'-丙基[2,6'-联-1H-苯并咪唑]-1'-基)甲基]联苯-2-甲腈 | (4′-((1,7′-dimethyl-2′-propyl-1H,3′H-[2,5′-bibenzo[d]imidazol]-3′-yl)methyl)-[1,1′-biphenyl]-2-carbonitrile) | 144702-27-2 | C33H29N5 |
|
| 4',6'-二硝基-2'-苯氧基甲烷磺酰苯胺 | N-(2,4-Dinitro-6-phenoxyphenyl)methanesulfonamide | 51765-56-1 | C13H11N3O7S |
|
| 3’-去(二甲基氨基)-3’-氧代阿奇霉素 | desdimethyl-keto-AZT | 612069-25-7 | C36H65NO13 |
|
| 3’-N,N-二(去甲基)阿奇霉素 | 3'-N,N-didemethyl-9-deoxo-9a-methyl-9a-aza-9a-homoerythromycin A | 612069-27-9 | C36H68N2O12 |
|
| 3Β,6Z-9,10-断胆甾基-5(10),6,8-三烯甘油酯-3 | previtamin D3 | 1173-13-3 | C27H44O |
|
| 3H-4,7a-甲桥环庚[3,3a]茚并[5,4-b]氧杂环丁烯苯丙酸衍生物 | Paclitaxel Photodegradant | 146139-03-9 | C47H51NO14 |
|
| 3-酮基-2-邻硝亚苄基-丁酰苯胺 | methyl 2-(2'-nitrobenzylidene)acetoacetate | 39562-27-1 | C12H11NO5 |
|
| 3-苯胺基-2-(3,4,5-三甲氧基苄基)丙烯腈 | 3-anilino-2-(3,4,5-trimethoxybenzyl)propenenitrile | 30078-48-9 | C19H20N2O3 |
|
| 3-苯基二氮烯基苯甲酸 | 3-phenylazobenzoic acid | 14474-22-7 | C13H10N2O2 |
|
| 3-苯基-4-苄基-5-甲基异恶唑 | 3-Phenyl-4-benzyl-5-methylisoxazole | 139395-94-1 | C17H15NO |
|
| 3-苯基-3-(o-甲氧基苯基)丙胺盐酸盐 | 3-phenyl-3-(o-methylphenoxy)propylamine hydrochloride | 881995-46-6 | C16H19NO*ClH |
|
| 3-苯基-2(1H)-吡嗪酮 | 3-phenylpyrazin-2(1H)-one | 2882-18-0 | C10H8N2O |
|
| 3-苄基-2-甲基咪唑-4-甲醛 | 1-benzyl-2-methyl-1H-imidazole-carbaldehyde | 39269-74-4 | C12H12N2O |
|
| 3-脱羟基2,3-去氢阿托伐他汀内酯 | (S)-5-(4-fluorophenyl)-2-isopropyl-1-(2-(6-oxo-3,6-dihydro-2H-pyran-2-yl)ethyl)-N,4-diphenyl-1H-pyrrole-3-carboxamide | 442851-50-5 | C33H31FN2O3 |
|
| 3-肼基苯甲酰胺 | 3-hydrazino-benzoic acid amide | 473927-51-4 | C7H9N3O |
|
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