Devendra Pratap Singh Email & Phone Number

Hyderabad, Telangana, India

Method development and impurity profiling.

Hyderabad Area, India

Method Development & Impurity Profiling

Pune Area, India

Method development for related substances of drug substance, its intermediates and raw materials by HPLC.Chemical and physical forced degradation study and separating degradants, thus providing stability indicating methods.Method development for genotoxic impurities in drug substances.Method development for assay and enantiomeric purity of drug substances.Method development on UPLC and transferring method from HPLC to UPLC.Analytical Method Validation of drug substances under regulatory requirements and with cGLP and cGMP complies.Method development for carryover of ions in drug substances by ion-exchange chromatography.Method development for raw materials and intermediate steps on GC.Development and analysis of residual solvents by using Headspace on GC.Review and prepare Protocol and Report of Analytical Method Validation as per company and regularities requirements.Ensuring the proper analytical technology transfer to Quality Control Department.Preparation of STPs, specifications & technical reports for the developed methods.Preparation, review and implementation of Standard Operating Procedures (SOP) for analytical laboratory under cGLP guidelines.Troubleshooting of instruments.Ensuring proper housekeeping of lab & up keeping and review of lab notebooks.Calibration and OQ and PQ of instruments.Cleaning Method development and Validation for GMP equipments.

Analytical method development.

Wet analysis.Reaction monitoring, complete analysis of samples including GC, HPLC and other tests.Method development on HPLC and GC.