Advances in Forced Degradation Studies of Pharmaceuticals Agenda

Registration

Inauguration

Session Chair
Sumathi Rao, Vice President- Formulation Analytical Research Department, Aurobindo Pharma Research center, India

Coffee Break and Networking in Exhibition Area

Session Chair
Sumathi Rao, Vice President- Formulation Analytical Research Department, Aurobindo Pharma Research center, India

Forced Degradation Studies & Protocols – Industry Perspective
Alok Chaudhary, Senior Research Scientist, Ranbaxy, India

This talk will address the industrial practices and their protocols on acid-alkali hydrolysis, oxidation, photo degradation, thermal and humidity degradation studies. Recent proposals for upgrading the existing degradation practices with a target of better mass balance and degradation closer to real time conditions will be the part of discussion. Solubility concerns in degradation mixture and approaches establishing direct correlation of degradation between assay and related substances methodologies will be addressed alongwith.

Technology Spotlight:
Systematic approach for identifying, characterizing and evaluation Impurities and degradents
K K Bhagchandani, Director, Advanced Chemistry Development Inc

Lunch Break and Networking in Exhibition Area

Poster Evaluation

Session Chair
Mariappanadar Vairamani, Dean, SRM University, India

Forced Degradation Products: Their Relevance and Identification/Characterization
Saranjit Singh, Professor/Head, NIPER Mohali, India

This presentation will discuss the relevance and importance of degradation products in pharmaceutical substances and products. It will highlight a strategy for the characterization of degradation products involving use of hyphenated LC-MS, LC-NMR and LC-IR techniques. The same will be duly explained through multiple case studies.

Characterization of Drug Metabolites and Degradation Products using LC-ESI-MS/MS
R Srinivas, Head, Indian Institute of Chemical Technology, India

This presentation will focus on stress studies, metabolic identification and structural characterization of drug degradation products and metabolites,in-vivo metabolic investigation of drug molecules using analytical technique like Liquid Chromatography Electrospray Ionization Tandem Mass Spectrometry combined with H/D exchange.

Coffee Break and Networking in Exhibition Area

Session Chair
R Srinivas, Head, Indian Institute of Chemical Technology, India

Reaction Mechanisms under Different Forced Degradation Conditions
R Nageswara Rao, Chief Scientist/Head, Analytical Chemistry, Indian Institute of Chemical Technology, India

In this talk, major mechanisms of chemical decomposition of pharmaceuticals including hydrolysis/dehydration, oxidation, isomerization/epimerization, decarboxylation, rearrangements, dimerization/polymerization, and photolysis and transformation products involving reactions with excipients/salt forms will be discussed. The use of advanced analytical techniques in proposing/predicting the reaction mechanisms of pharmaceutical degradations will also be covered.

Poster Award Presentation and Vote of Thanks

End of the Conference