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 |
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N-[(3,4-二氯苯基)甲基]-N'-辛基-亚氨基二亚胺酰胺 | 1-(3,4-dichlorobenzyl)-5-octylbiguanide | 146510-36-3 | C17H27Cl2N5 |
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N-[(2Z)-哌嗪-2-亚基]-2,2,2-三氟乙酰肼 | 2,2,2-trifluoro-N'-[(2Z)-piperazin-2-ylidene]acetohydrazide | 763105-70-0 | C6H9F3N4O |
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N-[(2'-氰基联苯-4-基)甲基]-N-(1-氧代戊基)-L-缬氨酸甲酯 | methyl 2-(N-((2'-cyanobiphenyl-4-yl)methyl)pentanamido)-3-methylbutanoate | 137863-90-2 | C25H30N2O3 |
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N-[(2'-氰基[1,1'-联苯]-4-基)甲基]-1-[(1-氧代戊基)氨基]环戊烷甲酰胺 | 1-pentanoylamino-cyclopentanecarboxylic acid (2'-cyano-biphenyl-4-ylmethyl)-amide | 141745-71-3 | C25H29N3O2 |
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N-[(1S)-2-氨基-2-氧代-1-(苯基甲基)乙基]-2-吡嗪甲酰胺 | Pyrazine-2-carboxylic acid ((S)-1-carbamoyl-2-phenyl-ethyl)-amide | 289472-80-6 | C14H14N4O2 |
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N-[(1R)-2-[5-(2-氟-3-甲氧基苯基)-3-[[2-氟-6-(三氟甲基)苯基]甲基]-3,6-二氢-4-甲基-2,6-二氧代-1(2H)-嘧啶基]-1-苯基乙基]氨基甲酸叔丁酯 | tert-butyl (R)-(2-(5-(2-fluoro-3-methoxyphenyl)-3-(2-fluoro-6-(trifluoromethyl)benzyl)-4-methyl-2,6-dioxo-3,6-dihydropyrimidin-1(2H)-yl)-1-phenylethyl)carbamate | 830346-51-5 | C33H32F5N3O5 |
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N-[(1,4-苯并二烷-2-基)羰基]哌嗪盐酸盐 | N-(2,3-dihydro-1,4-benzodioxin-2-yl carbonyl)piperazine hydrochloride | 70918-74-0 | C13H16N2O3*ClH |
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N-3-氯丙基-N-2-氯乙胺 | N-<2-Chlor-ethyl>-3-chlor-propylamin | 42453-19-0 | C5H11Cl2N |
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N-3-[3-(1-哌啶甲基)-苯氧基]丙胺 | 3-[3-(piperidin-1-ylmethyl)phenoxy]propylamine | 73278-98-5 | C15H24N2O |
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N-2-羟基-3-[[2-(甲氧基苯氧基)乙基]胺卡维地洛 | 1-(4-(2-hydroxy-3-(2-(2-methoxyphenoxy)ethylamino)propoxy)-9H-carbazol-9-yl)-3-(2-(2-methoxyphenoxy)ethylamino)propan-2-ol | 1198090-73-1 | C36H43N3O7 |
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N-1-丁基-1-去甲基乙基托拉塞米 | Desisopropyl butyl torsemide | 160972-33-8 | C17H22N4O3S |
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N-(甲基磺酰基)-N-(2-苯氧基苯基)甲烷磺酰胺 | N-(Methylsulfonyl)-4-(desnitro) Nimesulide | 905858-63-1 | C14H15NO5S2 |
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N-(甲基磺酰基)-4'-硝基-2'-苯氧基甲烷磺酰苯胺 | N-Methylsulfonyl Nimesulide | 51765-72-1 | C14H14N2O7S2 |
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N-(乙基氨基)氟伏沙明 | N-(Ethylamino) Fluvoxamine | 1217262-11-7 | C17H26F3N3O2 |
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N-(4-羟基苄基)-3.4-二甲氧基苯甲酰胺 | N-(4-hydroxybenzyl)-3,4-dimethoxybenzamide | 943518-63-6 | C16H17NO4 |
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N-(4-羟基-3-甲氧基苄基)癸烷酰胺 | N-vanillyl decanamide | 31078-36-1 | C18H29NO3 |
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N-(4-氟苄基)-1-(4-氟苯基)甲胺 | bis(4-fluorobenzyl)amine | 134227-41-1 | C14H13F2N |
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N-(4-乙氧基苯基)羟胺 | N-hydroxyphenetidine | 38246-95-6 | C8H11NO2 |
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N-(4-(3-氰基-2-甲基-1-丙酰)苯基)乙酰胺 | 4'-(3-Cyano-2-methylpropionyl)-acetanilid | 42075-21-8 | C13H14N2O2 |
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N-(4,5-二氢-1H-咪唑-2-基)-6-喹喔啉胺 | UK-41511 | 91147-43-2 | C11H11N5 |
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N-(3-氯苯基)-N'-(异丙基)亚胺基二亚氨甲酰胺盐酸盐 | 1-(3-Chlorophenyl)-5-isopropylbiguanide monohydrochloride | 1071546-52-5 | C11H17Cl2N5 |
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N-(3-氯-4-羟苯基)乙酰苯胺 | 3-chloro-4-hydroxyacetanilide | 3964-54-3 | C8H8ClNO2 |
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N-(3-氨基丙基)二乙醇胺 | 2,2'-[(3-aminopropyl)imino]bis-ethanol | 4985-85-7 | C7H18N2O2 |
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N-(2-苯甲酰基-4-氯苯基)甲酰胺 | N-(2-benzoyl-4-chlorophenyl)formamide | 10352-28-0 | C14H10ClNO2 |
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N-(2-羟基乙基)异烟酰胺 | isonicotinic acid N-(β-hydroxyethyl)amide | 6265-74-3 | C8H10N2O2 |
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N-(2-氯-6-甲基苯基)-2-{[2-甲基-6-(1-哌嗪基)-4-嘧啶基]氨基}-1,3-噻唑-5-甲酰胺 | N-(2-chloro-6-methylphenyl)-2-((2-methyl-6-(piperazin-1-yl)pyrimidin-4-yl)amino)thiazole-5-carboxamide | 910297-51-7 | C20H22ClN7OS |
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N-(2-氨基-2-氧代乙基)-2-(4-羟基-2-氧代吡咯烷-1-基)乙酰胺 | N-(2-amino-2-oxoethyl)-2-(4-hydroxy-2-oxotetrahydropyrrol-1-yl)acetamide | 120428-80-0 | C8H13N3O4 |
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N-(2,6-二甲基苯基)-2-[(5-氯戊基)甲基氨基]乙酰胺 | 2-[(5-Chloro-pentyl)-methyl-amino]-N-(2,6-dimethyl-phenyl)-acetamide | 29622-29-5 | C16H25ClN2O |
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N-(2,6-二甲基苯基)-2-(乙基甲基氨基)乙酰胺 | N-(2,6-Dimethylphenyl)-2-(ethylmethylamino)acetamide Hydrochloride | 50295-20-0 | C13H21ClN2O |
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N-(2,4-二氯-5-羟基苯基)乙酰胺 | N-(2,4-dichloro-5-hydroxyphenyl)acetamide | 67669-19-6 | C8H7Cl2NO2 |
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N-(2,4-二氯-5-甲氧基苯基)乙酰胺 | 4,6-dichloro-3-methoxyacetanilide | 65182-98-1 | C9H9Cl2NO2 |
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N-(1-羟基-2-(羟基甲基)-4-(4-辛基苯基)-2-丁基)乙酰胺 | N-(1-hydroxy-2-(hydroxymethyl)-4-(4-octylphenyl)butan-2-yl)acetamide | 249289-10-9 | C21H35NO3 |
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N-((4-氟苯基)甲基)乙酰胺 | N-(4-fluorobenzyl)acetamide | 86010-68-6 | C9H10FNO |
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N,N’-双(2-氯乙基)脲 | 1,3-bis(2-chloroethyl)urea | 2214-72-4 | C5H10Cl2N2O |
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N,N’-二羟乙基-1,3-丙二胺 | N,N'-bis(2-hydroxyethyl)-1,3-propanediamine | 10563-27-6 | C7H18N2O2 |
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N,N-二甲基对硝基苯胺 | N,N-dimethyl-2-nitro-benzenamine | 610-17-3 | C8H10N2O2 |
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N,N-二甲基-5-[[[2-[[1-(甲硫基)-2-硝基乙烯基]氨基]乙基]硫代]甲基]-2-呋喃甲胺 | 1-<2-<(5-Dimethylaminomethyl-2-furyl)-methylthio>-ethylamino>-1-methylthio-2-nitroethylen | 72115-14-1 | C13H21N3O3S2 |
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N,N-二甲基-3-(5-氧代-10H-吩噻嗪-10-基)-1-丙胺 | promazine sulfoxide | 146-21-4 | C17H20N2OS |
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N,N-二(2-氯乙基)-二氨基磷酸 3-羟基丙基酯 | O-(3-Hydroxypropyl)-N,N-bis(2-chloroethyl)phosphorodiamidate | 52336-54-6 | C7H17Cl2N2O3P |
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N,N-二(2-吡啶甲基)乙二胺 | (2-aminoethyl)bis(2-pyridylmethyl)amine | 189440-33-3 | C14H18N4 |
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N,N-(氧代二-4,1-亚苯基)二乙酰胺 | 4,4'-diacetamidodiphenyl ether | 3070-86-8 | C16H16N2O3 |
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N,N'-双(3-吡啶)脲 | 1,3-dipyridin-3-ylurea | 39642-60-9 | C11H10N4O |
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N,N'''-[亚二硫基二(亚甲基-4,2-噻唑二基)]二胍 | Famotidine disulfide | 129083-44-9 | C10H14N8S4 |
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N,3-二苯基-2-(2-甲基-1-氧代丙基)4-氧代-N-苯丁酰胺 | 4-methyl-3-oxo-2-(2-oxo-1,2-diphenylethyl)-N-phenylpentanamide | 444577-70-2 | C26H25NO3 |
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N'-((2S,3S)-2-(苄氧基)戊-3-基)甲酰肼草酸盐 | N'‑((2S,3S)‑2‑(benzyloxy)pentane‑3‑yl)carboxylhydrazide oxalate | 1887197-42-3 | C2H2O4*C13H20N2O2 |
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LCZ700杂质 | (2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(2,5-dioxopyrrol-1-yl)-2-methyl pentanoate | 1038924-97-8 | C24H27NO4 |
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LCZ696杂质900-04 | lbq657 | 149709-44-4 | C22H25NO5 |
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L-谷氨酸,N-[4-(甲基氨基)苯甲酰]-,二甲基酯 | N-<4-(methylamino)benzoyl>-L-glutamic acid dimethyl ester | 101810-76-8 | C15H20N2O5 |
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L-葡糖酸-1,5-内酯 | L-glucono-1,5-lactone | 52153-09-0 | C6H10O6 |
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L-苏氨酸-3-(3,4-二羟基苯基)丝氨酸 | L-threo-3-(3,4-dihydroxyphenyl)serine | 34047-62-6 | C9H11NO5 |
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