Sun Pharmaceutical Industries Ltd, India
Somenath Ganguly has completed his PhD at the age of 28 years from Indian Institute of Technology, Kharagpur. He is the Associate director in the Analytical Research Department of Sun Pharmaceutical Industries Limited, Gurgaon. Sun Pharma is a premier generic pharmaceutical organization. He has published more than 10 papers and patents. He is having about twenty years of experiences in the pharmaceutical analytical research and responsible for solid state characterization, impurity profiling and chromatographic method development activities. He has vast experiences in regulatory and quality requirements in the pharmaceutical industries
In recent days hyphenated mass spectrometric techniques are becoming an essential tool in generic pharmaceutical analysis. United States and European pharmacopeia recommends methods in the general chapters and monographs. Techniques involve are LCMS/MS; GCMS; ICP MS; TGA MS etc. ICH; OSHA, EMEA , US FDA published guidelines for assessing genotoxic and elemental impurities in the active pharmaceutical ingredient( API) and finished drug products. Genotoxic impurities involves structures like Epoxides; Alkylating agents; Aldehydes; Nitro compounds; Hydrazines; Azo compounds etc. Elemental impurities arising out of the catalysts used in the API synthesis like palladium charcoal; nickel acetate, borohydrides; metal residues from reactors line like lead, arsenic, mercury and cadmium. The quantitation levels of these impurities are determined based on maximum daily intake of the drugs and in general limits are in the range of less than 50 ppm. Analytical methods need to be developed, adequately validated and transferred to QC locations as per ICH and regulatory requirements. Challenges and procedures in the analytical method development and validations process involving hyphenated mass spectrometric techniques will be discussed.