Purity determination of the starting materials used in the synthesis of pharmaceutical substances

Abstract

High requirements for the API quality mean that the quality control of the starting material is crucial in the manufacturing process of drug substances. Three sensitive methods for the purity determination of the following starting materials: ethylene glycol (method I), 3-acetylpyridine (method II) and 4-chloromethyl-5-methyl-1,3-dioxol-2-one (method III) used in the syntheses of selected drug substances were developed using GC-FID techniques. All the methods were validated according to the International Conference on Harmonization guidelines. The correlation coefficient values were found to be about 0.99. The calculated RSD values from the replicate injections in the range of 20-120% of the nominal concentration ensured the precision of the methods.