Pramit Roy Email & Phone Number

Method development for Q1 & Q2 part for ANDA submission. Drug distribution in different phases (like, aqueous phase, Oil phase and Micelles) of o/wemulsion by different techniques (like Ultra-centrifuge, Ultrafiltration and others) Working on PLGA based microsphere of Injectable suspension. Characterization of PLGA (Molecular weight by GPC, LA & GA ratio, End capping andParticle Shape & Size by SEM). Develop the Real time and Accelerated drug release method for Microsphere in USP TypeIV and Water shaking bath. Method development for Particles size distribution methods using Mastersizer (2000 & 3000for micron range) and Zetasizer (For nano range). Analytical method development for discriminating and release dissolutions (media andparameters). using USP Apparatus I, II, IV and Immersion Cell Apparatus. Franz diffusion dissolution also handled for Topical formulation. Develop of a method for measurement of Viscosity and Rheological characteristics(Determination of LVER Region, Yield stress, Storage and Loss modulas cross over) ofvarious dose forms. Develop analytical methods such as Assay and Related substances for product developmentsupport. The development of equipment cleaning methods. Develop Zeta potential, Osmolarity and Buffer capacity in various dosage forms. Transfer of analytical procedures to respective locations as per requirements. Validation of Analytical methods (Assay, Dissolution, Related substance, Particle size,Viscosity and Rheology) DMF review and of preparation of API evaluation report. Preparation of analytical development strategy and method development report. Stability data compilation and trend evaluation. Preparation of analytical transfer protocol and report. Preparation of AMV protocol and report (validation and verification).