Pharma solutions by GC-MS/MS for Genotoxic Impurities
The following webinar talks about introduction to Genotoxic impurities, current regulations, Shimadzu solution with respect to method development workflow for GTI’s & well-developed applications for quantitation of GTI’s emphasising more on Nitrosamine quantitation in Valsartan & Metformin along with few other applications. It also discusses Shimadzu’s GCMS configurations and accessories as a complete solution for Pharmaceutical analysis.
Drug substances may include some amount of impurities, which can have adverse effect on human health. These types of DNA reactive molecules are termed as Genotoxic Impurities. The principal concern relating to drug safety is due to prolonged exposure of these compounds that can alter (alkylate) DNA may ultimately produce a carcinogenic response. Presence of these impurities has posed significant problems for drug regulators and industry alike over the last decade or so. A further practical issue is that the conventional testing procedures applied to drug substances, lack sufficient sensitivity to detect these impurities. To meet these demands, Shimadzu GCMSMS, with its Smart Database, user-friendly software & well-developed Applications can prove to be crucial for analysing variety of Genotoxic Impurities in Drug Substances.
Presenter: Nitish R. Suryawanshi (Application Chemist, Shimadzu Analytical India Pvt. Ltd.)
Nitish R. Suryawanshi is working as Application Chemist at Shimadzu Analytical (India) Pvt. Ltd. since 2016. He holds a Master’s degree in Bioanalytical Sciences from Mumbai University & has significant experience working with top Pharmaceuticals organizations.
At Shimadzu he is looking after GC-GCMS & Headspace product line & provides support mainly to Pharmaceutical and Chemical industry. His key areas involve activities like, method development/transfer, troubleshooting, on site demonstrations and trainings to customer and has been instrumental providing complete solution in the form of validated methods/ on site demo to Shimadzu customers related to Nitrosamine analysis in Sartans & Metformin Drugs.
