|
Abstract In the production process of ganciclovir, there are four kinds of solvents: methanol, ethanol, ethyl acetate, N,N-dimethyl formamide, which were contained into ICH limits. Here, methanol and N,N -dimethyl formamide belong to grade II solvents, ethanol and ethyl acetate belong to grade III solvents. The two kinds of solvents should be controlled to ensure the products’ quality. Capillary analysis method is usually used to test residual solvents because of its high sensitivity and small influence on the chromatographic system. The testing method of residues of methanol, ethanol, ethyl acetate , N,N -dimethyl formamide were established according to the Chinese pharmacopoeia 2010, volumⅡ“Method for determination of residual solvents”. The studies by various methods confirms that this method was simple, sensitive, accurate, reproducible, applicable for the quality control of products.
|