Responsible for Analytical Developmental Activities

Team leader for the Analytical method Validations and Developments for the different dosage forms (Injectables and Solid oral dosage forms)

Analytical method development and validations for injectables (oncology) by HPLC and GC,stability analysis compilations for injections and tablets, Analytical method transfers,Hold time tubing syringe compactbility study for paranterals• Analytical Method Development for Onco Drugs (parenterals)• Analysis of in process Samples, Finished Products, Preformulation studies and Stability Samples of Drug Products like Tablets and parenterals.• Compilation and Monitoring the Impurity Profile during Stability Studies and its investigation.• Performing Reconstitution study for Parenterals (Dry powder and Lyophilized vial for injection) using various diluents.• Responsible for procurement of Reference standards and preparation of working standards.• Monitoring Instrument Calibration due dates and performing the Instrument calibrations.INSTRUMENTS HANDLED:• Waters alliance HPLC system with Empower-2 Software and Chromeloin 7.0.• Shimadzu HPLC with Empower-2 Software and Chromeloin 7.0.• Agilent HPLC with Empower-2 Software• Dissolution Apparatus- Electro lab, and Distek Manual and Auto Sampler.• Waters, Agilent & Shimadzu HPLC with UV, PDA and RI Detectors.• Waters with Dionex Carona Detector (CAD).• Total Organic carbon Analyzer• Perkin Elmer GC with Empower-2 Software and Chromeloin 7.0• UV- VIS Spectrophotometer & IR - Perkin Elmer.• Particle Size Distributor- Sympotec and Malvern.• Ion chromatography by Metrohm 850 professional IC. • Polarimeter – Rudolph• DSC Thermoscientific• KF-Auto titration, Coulometer(Metrohm), Viscometer( Brookfield ) and etc.,