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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
N-甲基-gamma-(4-甲基苯氧基)苯丙胺盐酸盐 N-methyl-3-phenyl-(p-methylphenoxy)propylamine hydrochloride 873310-31-7 C17H21NO*ClH
N-甲基-N-乙基氨基甲酰氯 N-ethyl-N-methylcarbamoyl chloride 42252-34-6 C4H8ClNO
N-甲基-N,N-二(2-吡啶基乙基)胺 N-Methyl-N,N-di-<2-(2-pyridyl)ethylamine> 5452-87-9 C15H19N3
N-甲基-5-[(1-吡咯烷基磺酰基)甲基]-1H-吲哚-3-乙胺 3-[(2-methylamino)ethyl]-5-(1-pyrrolidinylsulfonylmethyl)indole 334981-12-3 C16H23N3O2S
N-甲基-5,6-二羟基吲哚 5,6-dihydroxy-1-methylindole 4821-00-5 C9H9NO2
N-甲基-3-苯氧基-3-苯基-丙胺盐酸盐 N-methyl-3-phenoxy-3-phenyl-propylamine hydrochloride 873310-33-9 C16H19NO*ClH
N-甲基-3-苯基丙基氯化铵 N-Methyl-3-phenylpropylamine hydrochloride 30684-07-2 C10H16ClN
N-甲基-3-氯-3-苯丙胺盐酸盐 3-chloro-N-methyl-3-phenylpropan-1-amine hydrochloride 128036-32-8 C10H14ClN*ClH
N-氧化伐地那非 2-{2-ethoxy-5-[(4-ethyl-4-hydroxy-4λ5-piperazin-1-yl)sulfonyl]phenyl}-5-methyl-7-propyl imidazo-[5,1-f]-1,2,4-triazin-4(3H)-one N-oxide 448184-48-3 C23H32N6O5S
N-戊酰基氨基环戊烷-1-羧酸 1-pentanoylamino-cyclopentanecarboxylic acid 15026-80-9 C11H19NO3
N-异丙基去甲托品醇甲溴化物 N-Isopropyltropinium 58005-18-8 C11H22BrNO
N-异丙基卡维地洛 N-Isopropyl Carvedilol 1246819-01-1 C27H32N2O4
N-异丁基-4-哌啶酮 1-isobutylpiperidin-4-one 72544-16-2 C9H17NO
N-哌拉西林基氨苄西林 N-Piperacillinyl Ampicillin 65772-67-0 C39H44N8O10S2
N-叔丁氧羰基-西他列汀 (R)-tert-butyl 4-oxo-4-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-1-(2,4,5-trifluorophenyl)butan-2-ylcarbamate 486460-23-5 C21H23F6N5O3
N-去甲西酞普兰-D4草酸 Desmethylcitalopram oxalate 62498-68-4 C2H2O4*C19H19FN2O
N-去甲基长春碱 N-deformylvincristine 18172-50-4 C45H56N4O9
N-去甲基舒马普坦 N-methyl-2-[5-[[(methylamino)sulphonyl]methyl]-1H-indol-3-yl]ethanamine 88919-51-1 C13H19N3O2S
N-去甲基盐酸文拉法辛 (文拉法辛杂质D) N-Desmethylvenlafaxine hydrochloride 93413-90-2 C16H25NO2*ClH
N-去甲基多非利特 [Cy3B]-N-Demethyldofetilide 176447-94-2 C18H25N3O5S2
N-去甲基加兰它敏氢溴酸盐 N-desmethyl galantamine 41303-74-6 C16H19NO3
N-去甲基克拉霉素 N-desmethylclarithromycin 101666-68-6 C37H67NO13
N-去甲右美沙芬 (+)-3-methoxymorphinan 1531-25-5 C17H23NO
N-去乙基舒尼替尼三氟乙酸盐 N-Desethyl Sunitinib 356068-97-8 C20H23FN4O2
N-去丙基(R)-罗哌卡因 (R)-2',6'-pipecoloxylidide 27262-43-7 C14H20N2O
N-去[2-(甲基磺酰基)乙基]拉帕替尼 [6-(5-Aminomethyl-furan-2-yl)-quinazolin-4-yl]-[3-chloro-4-(3-fluoro-benzyloxy)-phenyl]-amine 697299-82-4 C26H20ClFN4O2
N-去(环己基氨基羰基)格列吡嗪 6-Methyl-N-(2-(4-sulfamoylphenyl)ethyl)pyrazine-2-carboxamide 1346600-54-1 C14H16N4O3S
N-去(4-磺酰氨基苯基)-N'-(4-磺酰氨基苯基)塞来考昔 4-(3-(p-tolyl)-5-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide 331943-04-5 C17H14F3N3O2S
N-亚硝基-N-甲基环己胺 N-nitroso-N-methylcyclohexylamine 5432-28-0 C7H14N2O
N-亚硝基-3-氮杂双环[3.3.0]辛烷 2-nitroso-octahydrocyclopenta[c]pyrrole 54786-86-6 C7H12N2O
N-乙酰苯醌亚胺 N-acetyl-p-benzoquinoneimine 50700-49-7 C8H7NO2
N-乙氧羰基7-ADCA N-Ethoxycarbonyl 7-ADCA 72820-16-7 C11H14N2O5S
N-乙氧羰基-4-哌啶酮 N-ethoxycarbonyl-4-piperidone 29976-53-2 C8H13NO3
N-乙基他达拉非 N-Ethyl tadalafil 1609405-34-6 C23H21N3O4
N-乙基-N-甲基-3-乙烯基苯基氨基甲酸酯 3-vinylphenyl ethyl(methyl)carbamate 1346602-84-3 C12H15NO2
N-乙基-4-羟基-2-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-ethyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide 1,1-dioxide 881399-30-0 C16H17N3O4S2
N-乙基-2-氨甲基吡咯烷 1-ethyl-2-pyrrolidinemethanamine 26116-12-1 C7H16N2
N-三苯甲基坎地沙坦乙酯 ethyl 2-ethoxy-1-{[2'-[1-(triphenylmethyl)-1H-tetrazol-5-yl]-1,1'-biphenyl-4-yl]methyl}-benzimidazole-7-carboxylate 856414-35-2 C45H38N6O3
N-[[P(S),2'R]-2'-脱氧-2'-氟-2'-甲基-P-苯基-5'-胞苷酰]-L-丙氨酸异丙酯 isopropyl ((S)-(((2R,3R,4R,5R)-5-(4-amino-2-oxopyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)(phenoxy)phosphoryl)-L-alaninate 1334513-10-8 C22H30FN4O8P
N-[[2'(-(1H-四唑-5-基)[1,1'(-联苯]-4-基]甲基]-L-缬氨酸 desvaleroyl valsartan 676129-92-3 C19H21N5O2
N-[[(六氢环戊二烯并[c]吡咯-2(1H)-基)氨基]羰基]-2-甲基苯磺酰胺 ortho Gliclazide 1076198-18-9 C15H21N3O3S
N-[4-氯-3-(三氟甲基)苯基]-乙酰胺 N-<4-chloro-3-(trifluoromethyl)phenyl>acetamide 348-90-3 C9H7ClF3NO
N-[4-氧代-4-(3-吡啶基)丁基]甲酰胺 4-(formamido)-1-(3-pyridyl)-1-butanone 887355-56-8 C10H12N2O2
N-[4-2-(甲酰氨基乙酰基)-5-甲氧基-2-苯氧基苯基)]-甲磺酰胺 N-[4-(2-formylaminoacetyl)-5-methoxy-2-phenoxyphenyl]methanesulfonamide 149456-98-4 C17H18N2O6S
N-[4-(甲基氨基)苯甲酰基]-L-谷氨酸 p-(N-methylamino)benzoyl-L-glutamic acid 52980-68-4 C13H16N2O5
N-[4-(嘧啶-2-基氨基磺酰基)苯基]乙酰胺 4'-(pyrimidin-2-ylsulfamoyl)acetanilide 127-74-2 C12H12N4O3S
N-[2-(3,4-二甲氧基苯基)乙基]-2-(3,4-二甲氧基苯基)乙胺 N-<2-(3,4-dimethoxyphenyl)ethyl>-2-(3,4-dimethoxyphenyl)ethylamine 24997-88-4 C20H27NO4
N-[2-(1H-吲哚-4-基)乙基]-N-丙基丙-1-胺 4-<2-(N,N-di-n-propylamino)ethyl>indole 76149-15-0 C16H24N2
N-[1-(4-甲氧基苯基)-2-甲基丙-2-基]乙酰胺 N-[1-(4-methoxyphenyl)-2-methylpropan-2-yl]acetamide 926319-54-2 C13H19NO2
N-[(反式-4-异丙基环己基)羰基]-D-苯丙氨酸甲酯 N-[(trans-4-Isopropylcyclohexyl)carbonyl]-D-phenylalanine methyl ester 105746-47-2 C20H29NO3