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 |
|---|---|---|---|
| 1-(3-氯丙基)-3-(三氟甲基)苯 | 1-(3-chloropropyl)-3-(trifluoromethyl)benzene | 82258-76-2 | C10H10ClF3 |
| 1-(3-氨基丙基)-1-(4-氟苯基)-1,3-二氢-5-异苯并呋喃甲腈 | didesmethylcitalopram | 62498-69-5 | C18H17FN2O |
| 1-(3-氨基-5-(苄氧基)-2-羟基苯基)乙酮 | 1-[2-hydroxy-3-amino-5-(benzyloxy)phenyl]ethanone | 861841-90-9 | C15H15NO3 |
| 1-(3-氨基)-4-(2-甲氧基苯基)哌嗪 | 3-(4-(2-methoxyphenyl)piperazin-1-yl)propylamine | 20529-23-1 | C14H23N3O |
| 1-(3,5-二羟基苯基)-2-[(1,1-二甲基乙基)氨基]-乙酮盐酸盐 | 1-(3,5-Dihydroxyphenyl)-2-[(1,1-dimethylethyl)amino]-ethanone Hydrochloride | 1246815-70-2 | C12H18ClNO3 |
| 1-(3,4-二甲基苯基)乙醇 | 1-(3,4-dimethylphenyl)ethanol | 33967-19-0 | C10H14O |
| 1-(3,4-二氯苯基)-5-异丙基双胍单盐酸盐 | Chlorproguanil hydrochloride | 6001-93-0 | C11H15Cl2N5*ClH |
| 1-(3,4,5-三甲氧基苄基)哌嗪二盐酸盐 | 1-(3,4,5-Trimethoxy-benzyl)-piperazine dihydrochloride | 107049-57-0 | C14H24Cl2N2O3 |
| 1-(2-甲基丙基)-1H-咪唑并[4,5-c]喹啉 5,n-氧化物 | 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinoline 5N-oxide | 99010-63-6 | C14H15N3O |
| 1-(2-甲基-5-硝基咪唑-1-基)丙-2-酮 | 1-(2-methyl-5-nitro-1H-imidazol-1-yl)propan-2-one | 31876-69-4 | C7H9N3O3 |
| 1-(2-溴苯基)哌嗪盐酸盐 | 1-(2-bromophenyl)piperazine hydrochloride | 853745-55-8 | C10H13BrN2*ClH |
| 1-(2-氯乙酰基)脯氨酸 | (S)-1-(2-chloroacetyl)pyrrolidine-2-carboxylic acid | 23500-10-9 | C7H10ClNO3 |
| 1-(2-氯乙基)-3-(二环丙基甲基)脲 | 1-(2-chloroethyl)-3-(dicyclopropylmethyl)urea | 54187-03-0 | C10H17ClN2O |
| 1-(2-氯-4-(环戊基氨基)-5-嘧啶)乙酮 | 5-acetyl-2-chloro-4-cyclopentylaminopyrimidine | 1244949-62-9 | C11H14ClN3O |
| 1-(2-氨基乙基)-7-甲氧基-1,2,3,4-四氢萘 | 1-(2-aminoethyl)-7-methoxy-1,2,3,4-tetrahydronaphthalene | 59081-66-2 | C13H19NO |
| 1-(2-氨基乙基)-3-(5-溴喹喔啉-6-基)脲 | Hydroxy brimonidine | 1216379-05-3 | C11H12BrN5O |
| 1-(2-氨基-1-(4-甲氧基苯基)乙基)环己醇盐酸盐 | (±)-N,N-didesmethylvenlafaxine hydrochloride | 130198-05-9 | C15H23NO2*ClH |
| 1-(2-乙氧基乙基)-1,3-二氢-2H-苯并咪唑-2-酮 | N-(2-ethoxyethyl)-2-benzimidazolone | 101953-61-1 | C11H14N2O2 |
| 1-(2-乙基磺酰乙基)-2-甲基-4-硝基咪唑 | 1-<2-(ethylsulphonyl)ethyl>-2-methyl-4-nitro-1H-imidazole | 25459-12-5 | C8H13N3O4S |
| 1-(2-O,3-O,5-O-三乙酰基-beta-D-阿拉伯呋喃糖基)-2,4(1H,3H)-嘧啶二酮 | 2',3',5'-Triacetyluridine | 14057-18-2 | C15H18N2O9 |
| 1-(2,6-二氯苯基)哌嗪 | 1-(2,6-dichlorophenyl)piperazine | 63386-61-8 | C10H12Cl2N2 |
| 1-(2,5-二氟苯基)-2-(1H-1,2,4-三唑-1-基)乙酮 艾沙康唑中间体 | 1-(2,5-difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)ethanone | 1157938-97-0 | C10H7F2N3O |
| 1-(2,3-环氧基丙基)-2-甲基-5-硝基咪唑 | 1-(2,3-epoxypropyl)-2-methyl-5-nitroimidazole | 16773-52-7 | C7H9N3O3 |
| 1-(1H-苯并[d]咪唑-2-基)-3-甲基-4-氧代-1,4-二氢吡啶-2-羧酸 | 1-(1H-Benzimidazol-2-yl)-3-methyl-4-oxo-1,4-dihydropyridine-2-carboxylic acid | 1163685-30-0 | C14H11N3O3 |
| 1-((2-氟苯基)氨基甲酰基)环丙烷甲酸(卡博替尼杂质) | 1-((2-fluorophenyl)carbamoyl)cyclopropane-1-carboxylic acid | 918642-61-2 | C11H10FNO3 |
| 1-((2'-氨基甲酰基-[1,1'-联苯基]-4-基)甲基)-2-乙氧基-1H-苯并[d]咪唑-7-羧酸 | 1-((2’-carbamoyl-[1,1’-biphenyl]-4-yl)methyl)-2-ethoxy-1H-benzo[d]imidazole-7-carboxylic acid | 1696392-11-6 | C24H21N3O4 |
| 1,5-二羟基-2,2,5,7-四甲基螺[1H-茚-6,1'-环丙烷]-4-酮 | illudin M | 1146-04-9 | C15H20O3 |
| 1,5-二氢-4H-咪唑并[4,5-d]-1,2,3-三嗪-4-酮 | 2-azahypoxanthine | 4656-86-4 | C4H3N5O |
| 1,4-双[(4-氯苯基)苯基甲基]哌嗪双盐酸盐 | 1,4-bis-(4-chloro-benzhydryl)-piperazine | 346451-15-8 | C30H28Cl2N2 |
| 1,4-双[(2-氧代-3,4-二氢-喹啉-7(1H)-基)-氧基]丁烷 | 7-(4-(2-oxo-1,2,3,4-tetrahydroquinolin-7-oxy)butoxy)-3,4-dihydroquinoline-2(1H)-one | 882880-12-8 | C22H24N2O4 |
| 1,4-双(4-硝基苯基)哌嗪 | 1,4-bis(4-nitrophenyl)piperazine | 16264-05-4 | C16H16N4O4 |
| 1,4-二羟基-7-苯氧基异喹啉-3-羧酸甲酯 | methyl 4-hydroxy-1-oxo-7-phenoxy-1,2-dihydroisoquinoline-3-carboxylate | 1421312-32-4 | C17H13NO5 |
| 1,4-二氢-7-甲氧基-4-氧代-6-喹啉甲酰胺 | 4-hydroxy-7-methoxyquinoline-6-carboxamide | 417724-81-3 | C11H10N2O3 |
| 1,4-二氢-2,6-二甲基-4-(3-硝基苯基)-3,5-吡啶二甲酸二异丙酯 | diisopropyl 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridine-dicarboxylate | 21881-78-7 | C21H26N2O6 |
| 1,4-二氢-2,6-二甲基-4-(3-硝基苯基)-3,5-吡啶二甲酸二(2-甲氧基乙基)酯 | nimodipine impurity c | 70172-96-2 | C21H26N2O8 |
| 1,4-二氢-2,6-二甲基-4-(3-氨基苯基)-5-(2-甲氧基乙氧羰基)-3-甲酸异丙酯 | 3-isopropyl 5-(2-methoxyethyl) 4-(3-aminophenyl)-2,6-dimethylpyridine-3,5-dicarboxylate | 155861-24-8 | C21H28N2O5 |
| 1,4-二对甲苯磺酰基-1,4-二氮杂环庚 | N,N'-di-p-toluenesulfonylhomopiperazine | 5769-35-7 | C19H24N2O4S2 |
| 1,4-二[(2,3-二氢-1,4-苯并二氧杂环己-2-基)羰基]哌嗪 | 1,4-bis-(2,3-dihydro-benzo[1,4]dioxin-2-carbonyl)-piperazine | 617677-53-9 | C22H22N2O6 |
| 1,4-二-2-糠酰基哌嗪 | N,N'-bis(furan-2-carbonyl)piperazine | 31350-27-3 | C14H14N2O4 |
| 1,4-丁二醇,单甲烷磺酸盐 | 4-Methansulfonyloxybutanol | 42729-95-3 | C5H12O4S |
| 1,4,8,11-四[(4-甲基苯基)磺酰基]-1,4,8,11-四氮杂环十四烷 | N,N',N'',N'''-tetratosyl-1,4,8,11-tetraazacyclotetradecane | 71089-74-2 | C38H48N4O8S4 |
| 1,4,7,10-四氮杂环十二烷-1,7-二乙酸 | 1,4,7,10-tetraazacyclododecane-1,7-diacetic acid | 112193-75-6 | C12H24N4O4 |
| 1,4,7,10-四氮杂环十二烷-1,4,7-三乙酸钆络合物 | Gd(DO3A) | 112188-16-6 | C14H22GdN4O6- |
| 1,4,5-三羟基-2-戊酮 | 1,4,5-Trihydroxypentan-2-one | 3343-53-1 | C5H10O4 |
| 1,4'-二甲基-2'-丙基-2,5'-联-1H-苯并咪唑 | 1,4'-dimethyl-2'-propyl-1H,1'H-2,5'-dibenzimidazole | 887583-89-3 | C19H20N4 |
| 1,3-苯并二氧戊环-5-基乙酸酯 | benzo[d][1,3]dioxol-5-yl acetate | 326-58-9 | C9H8O4 |
| 1,3-双(1H-1,2,4-三唑-1-基)-2-丙酮 | 1,3-bis(1H-1,2,4-triazol-1-yl)propanone | 98414-56-3 | C7H8N6O |
| 1,3-二甲硫基-2-丙醇 | 1,3-bis(methylthio)-2-propanol | 31805-83-1 | C5H12OS2 |
| 1,3-二甲基-5-硝基金刚烷 | 1,3-dimethyl-5-nitroadamantane | 6588-68-7 | C12H19NO2 |
| 1,3-二甲基-5,5-二烯丙基六氢嘧啶-2,4,6-三酮 | 5,5-diallyl-1,3-dimethyl-pyrimidine-2,4,6-trione | 722-97-4 | C12H16N2O3 |
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