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’-甲基联苯四氮唑 | 2-(tetrazol-5-yl)-4'-methyl-1,1'-biphenyl | 120568-11-8 | C14H12N4 |
|
| 4’-[[1,4’-二甲基-2’-丙基(2,6’-联-1H-苯并咪唑)-1’-甲基]-[1,1’-联苯基]-2-羧酸叔丁酯 | 4'-[[4-methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H-benzimidazole-1-yl]methyl]biphenyl-2-carboxylic acid tert-butyl ester | 144702-26-1 | C37H38N4O2 |
|
| 4beta,9alpha,12beta,13alpha,20-五羟基惕各-1,6-二烯-3-酮 | phorbol | 17673-25-5 | C20H28O6 |
|
| 4H-咪唑并[1,5-A][1,4]苯并二氮杂环庚烷-3-甲酸 | 8-Fluoro-5,6-dihydro-5-methyl-6-oxo-4H-imidazo[1,5-a][1,4]benzodiazepine-3-carboxylic acid | 84378-44-9 | C13H10FN3O3 |
|
| 4-（3,4-二氯苯基）-1,2,3,4-四氢-1-萘酚 | 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydronaphthalen-1-ol | 866018-46-4 | C16H14Cl2O |
|
| 4-表-6-表多西环素 | 4-epi-6-Epidoxycycline | 97583-08-9 | C22H24N2O8 |
|
| 4-苯基丁基膦酸 | 4-phenylbutylphosphonic acid | 46348-61-2 | C10H15O3P |
|
| 4-苯基-3-吗啉酮 | 4-phenylmorpholin-3-one | 29518-11-4 | C10H11NO2 |
|
| 4-羧基-alpha-甲基苯乙酸 | (±)-4-(1-carboxyethyl)benzoic acid | 67381-50-4 | C10H10O4 |
|
| 4-羟基苯乙酮肟 | 4-hydroxyacetophenone oxime | 34523-34-7 | C8H9NO2 |
|
| 4-羟基丙泊酚 | 2,6-di(2-propyl)hydroquinone | 1988-10-9 | C12H18O2 |
|
| 4-羟基-alpha1-[[[6-(3-苯基丙氧基)己基]氨基]甲基]-1,3-苯二甲醇 | 4-Hydroxy-α1-[[[6-(3-phenylpropoxy)hexyl]amino]methyl]-1,3-benzenedimethanol | 94749-11-8 | C24H35NO4 |
|
| 4-羟基-alpha1-[[[6-(2-苯基乙氧基)己基]氨基]甲基]-1,3-苯二甲醇 | Des(phenylbutoxy)phenylethoxy salmeterol | 94749-02-7 | C23H33NO4 |
|
| 4-羟基-N,2-二甲基-N-(5-甲基-1,3-噻唑-2-基)-2H-1,2-苯并噻嗪-3-甲酰胺1,1-二氧化物 | 4-hydroxy-2-methyl-N-methyl-(5-methyl-2-thiazolyl)-2H-l,2-benzothiazine-3-carboxamide-1,1-dioxide | 892395-41-4 | C15H15N3O4S2 |
|
| 4-羟基-7-甲氧基-6-喹啉羧酸 | 4-Hydroxy-7-methoxyquinoline-6-carboxylic acid | 417721-34-7 | C11H9NO4 |
|
| 4-羟基-2-甲基-2H-1,2-苯并噻嗪-3-甲酸异丙酯 1,1-二氧化物 | isopropyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide | 118854-48-1 | C13H15NO5S |
|
| 4-羟基-2-甲基-2H-1,2-苯并噻嗪-3-甲酸乙酯 1,1-二氧化物 | ethyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide | 24683-26-9 | C12H13NO5S |
|
| 4-羟基-1-甲基-7-苯氧基异喹啉-3-羧酸甲酯 | methyl 4-hydroxy-1-methyl-7-phenoxyisoquinoline-3-carboxylate | 1421312-34-6 | C18H15NO4 |
|
| 4-羟基-1,3-苯并二氧代 | 2H-benzo[d][1,3]dioxolan-4-ol | 69393-72-2 | C7H6O3 |
|
| 4-硝基苯基5-氯噻吩-2-羧酸酯 | 4-nitrophenyl 5-chlorothiophene-2-carboxylate | 1450877-56-1 | C11H6ClNO4S |
|
| 4-硝基-2-苯氧基苯酚 | Phenyl-(5-nitro-2-hydroxy-phenyl)-aether | 70995-08-3 | C12H9NO4 |
|
| 4-硝基-2-苯氧基苯胺 | 1-amino-2-phenoxy-4-nitrobenzene | 5422-92-4 | C12H10N2O3 |
|
| 4-硝基-1H-咪唑-1-乙醇 | 2-(4-nitro-1H-imidazol-1-yl)ethanol | 5006-69-9 | C5H7N3O3 |
|
| 4-甲酰基苯基-beta-d-吡喃葡萄糖苷 | 4-(β-D-glucopyranosyloxy)benzaldehyde | 26993-16-8 | C13H16O7 |
|
| 4-甲氨基巴豆酸 | (E)-4-(methylamino)but-2-enoic acid | 69169-63-7 | C5H9NO2 |
|
| 4-甲氧基间苯二甲酸 | 4-methoxyisophthalic acid | 2206-43-1 | C9H8O5 |
|
| 4-甲氧基-ALPHA-甲基-N-(苯甲基)苯乙胺盐酸盐 | benzyl-[2-(4-methoxy-phenyl)-1-methyl-ethyl]-amine; hydrochloride | 1049695-95-5 | C17H21NO*ClH |
|
| 4-甲氧基-6-硝基-3-[3-(4-吗啉基)丙氧基]-苯甲酰胺 | 2-nitro-4-methoxy-5-[3-(morpholin-4-yl)propoxy]benzamide | 861453-16-9 | C15H21N3O6 |
|
| 4-甲氧基-3,5-二甲基吡啶1-氧化物 | 3,5-dimethyl-4-methoxypyridine 1-oxide | 91219-89-5 | C8H11NO2 |
|
| 4-甲氧基-2,3,5-三甲基吡啶-n-氧化物 | 4-methoxy-2,3,5-trimethylpyridine-N-oxide | 86604-80-0 | C9H13NO2 |
|
| 4-甲氧基-2,3,5-三甲基吡啶 | 2,3,5-trimethyl-4-methoxypyridine | 109371-19-9 | C9H13NO |
|
| 4-甲基哌嗪-1-甲酰氯 | 4-methyl-1-piperazinecarbonyl chloride | 39539-66-7 | C6H11ClN2O |
|
| 4-甲基-6-吡啶-3-嘧啶-2-胺 | 3-(2-amino-4-methylpyrimidin-6-yl)pyridine | 90916-52-2 | C10H10N4 |
|
| 4-甲基-3-氧代-N-苯基-2-(苯甲烯基)戊酰胺 | 2-benzylidene-4-methyl-3-oxo-N-phenylpentanamide | 125971-57-5 | C19H19NO2 |
|
| 4-甲基-2-哌啶羧酸 | (2R,4R)-4-Methyl-piperidine-2-carboxylic acid | 172823-76-6 | C7H13NO2 |
|
| 4-甲基-1-苯基-1,3-戊烷二酮 | 1-(4-acetylphenyl)-2-methylpropan-1-one | 103931-20-0 | C12H14O2 |
|
| 4-甲基-1-哌嗪羧酸乙酯 | ethyl 4-methyl-1-piperazinecarboxylate | 59325-11-0 | C8H16N2O2 |
|
| 4-甲基-1-(3-硝基-5-三氟甲基-苯基)-1H-咪唑 | 4-methyl-1-(3-nitro-5-(trifluoromethyl)phenyl)-1H-imidazole | 916975-92-3 | C11H8F3N3O2 |
|
| 4-甲基-1-(3-甲基-2-吡啶基)-2-苯基哌嗪 | 5-methyl-6-(4-methyl-2-phenylpiperazin-1-yl)-pyridine | 191546-94-8 | C17H21N3 |
|
| 4-甲亚砜基苯甲酸 | 4-(methylsulfinyl)benzoic acid | 33963-58-5 | C8H8O3S |
|
| 4-环己基哌嗪-1-甲酸叔丁酯 | 4-cyclohexyl-piperazine-1-carboxylic acid tert-butyl ester | 1224935-95-8 | C15H28N2O2 |
|
| 4-溴苯并[b]噻吩-2-羧酸乙酯 | 4-Bromo-2-carbethoxybenzo<b>thiophene | 93103-82-3 | C11H9BrO2S |
|
| 4-溴-1-甲基-1H-吲唑 | N-Succinyl-L-tyrosine | 374816-32-7 | C13H15NO6 |
|
| 4-溴-1,2,3,4-四氢-1-(4-甲基苯磺酰基)-5H-1-苯并氮杂卓-5-酮 | 4-bromo-1-[(4-methylphenyl)sulfonyl]-1,2,3,4-tetrahydro-5H-1-benzazepin-5-one | 29489-04-1 | C17H16BrNO3S |
|
| 4-氰基苯硼酸-1,3-丙二醇酯 | 4-(1,3,2-dioxaborinan-2-yl)benzonitrile | 152846-62-3 | C10H10BNO2 |
|
| 4-氰基亚苄基溴 | 4-(dibromomethyl)benzonitrile | 67013-55-2 | C8H5Br2N |
|
| 4-氯苄亚基苯酞 | 3-(4-chlorobenzylidene)-2-benzofuran-1(3H)-one | 20526-97-0 | C15H9ClO2 |
|
| 4-氯甲基-N-[4-甲基-3-[[4-(吡啶-3-基)嘧啶-2-基]氨基]苯基]苯甲酰胺 | 4-(chloromethyl)-N-(4-methyl-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)phenyl)benzamide | 404844-11-7 | C24H20ClN5O |
|
| 4-氯兰索拉唑 | 2-[(RS)-[(4-chloro-3-methylpyridin-2-yl)methyl]sulfinyl]-1H-benzimidazole | 168167-42-8 | C14H12ClN3OS |
|
| 4-氯-7-(2-氯乙氧基)-6-(2-甲氧基乙氧基)喹唑啉 | 4-chloro-7-(2-chloro-ethoxy)-6-(2-methoxy-ethoxy)-quinazoline | 183322-20-5 | C13H14Cl2N2O3 |
|
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