Evaluating impurities in drugs--Part II

The genotoxins ethyl chloride, methyl chloride and isopropyl chloride were generated during the preparation of the hydrochloride salts of ethanol, methanol and isopropyl alcohol (ICH listed solvents) respectively at lower temperature (< 5 0C) as the key parameter of these impurities, in alcohol solvents, when HCl was 37% aqueous HCl or gas, it creates the maximum chance to form these alkyl fialide impurities at trace levels. These impurities are detectable in GC at ppm level.