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关于国际药典及其商品
2018-07-10 14:34

 
         医药行业对于医药药品有着严格的规定,根据国际医药品标准品,我国在医药行业发展也是突飞猛进,随着国家的高速发展,近几年医药行业品种的增多,国内在医疗行业监管有着整体进步,目前国内大型医疗企业都通过了国际认证,并且开始向国际很多国家出口,包括美国,欧洲,对于药品检测来说,药品标准品是检验是否符合国际药典最终结果。比如美国药典USP、欧洲药典EP、英国药典BP、日本药典JP等,都有自己作为国际出口标准,所以对于我国来说,出口药典非常重要。

        美同达有 以下不同标准的药典标准品供大家选用:


神经类部分产品如下:
拉莫三嗪Lamotrigine
Lamotrigine for peak identification
Lamotrigine for system suitability
Lamotrigine Imp. A (EP): 3-Amino-6-(2,3-dichlorophenyl)-1,2,4-triazin-5(4H)-one
Lamotrigine Related Compound B 2,3-dichlorobenzoic acid
Lamotrigine Related Compound C 3-amino-6-(2,3-dichlorophenyl)1,2,4-triazin-5(4H)-one
Lamotrigine Related Compound D N-[5-amino-6-(2,3-dichlorophenyl)-1,2,4-triazin-3-yl]-2,3-dichlorobenzamide
Lamotrigine impurity E 2,3-dichlorobenzoic acid
盐酸氟西汀Fluoxetine hydrochloride
Fluoxetine Related Compound A N-methyl-3-phenyl-3-[(alpha,alpha,alpha-(trifluoro-m-tolyl)oxy]propylamine HCl
Fluoxetine Related Compound B N-methyl-3-phenylpropylamine (Controlled Substance) Methyl-3-phenylpropylamin(1M-3PP)/(Methyl)(3-phenylpropyl)azan als Hydrochloride
Fluoxetine Related Compound C N-Methyl-N-[3-phenyl-3-(4-trifluoromethyl-phenoxy)-propyl] succinamic acid
米氮平Mirtazapine
Mirtazapine for system suitability
Mirtazapine Related Compound A 1,2,3,4,10,14b-hexahydropyrazino[2,1-a}pyrido[2,3-c][2]benzazepine
Mirtazapine Resolution Mixture
舒马曲坦Sumatriptan
Sumatriptan for system suitability
Sumatriptan impurity mixture
Sumatriptan Succinate Related Compound A [3-[2-(dimethylamino)ethyl]-2-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]methyl]-1H-indol-5-yl]-N-methylmethansulfonamide, succinate salt
Sumatriptan Succinate Related Compound C [3-[2-(dimethylamino)ethyl]-1-(hydroxymethyl)-1H-indol-5-yl]- N-methylmethanesulfonamide succinate salt

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