Prakash Kale

• To Perform analytical Method development For Related substance, Assay and Dissolution, by HPLC and UV.
• To Perform Analytical Method Validation for Assay and Related substances.
• To Perform Stability analysis for Assay, Dissolution and Related substances by HPLC, UV.
• To Perform Routine analysis and Stability analysis for Assay, Dissolution, Related substances, Content uniformity, Blend uniformity by HPLC, UV.
• Preparation of SOP,Analytical method development report,Analytical method validation report.
• Calibration of various instruments like pH meter, Balance and HPLC.
• Maintain Lab equipment as per GMP and GLP.

● Method development and Method verification for Related subtances and Assay for semi-solid drug product by HPLC.

● In-vitro release test(IVRT) study for semi-solid drug product.

● Dissolution method developments for drug product and drug substances

● Analytical method development and method verification by HPLC.

§ SOP preparations for instruments, Optimization report, Method of analysis and other documents preparations.

● Calibration of HPLC, Dissolution, Balance and pH Meter.

● Method validation and method qualification for KSM (Key starting material).

● Method qualification and method development for peptides molecules.

● Routine analytical testing of In-process sample includes reaction mass sample,Purification sample etc.

● Performed Stability study for various sample.

● Handling and Analysis for drug product by using UPLC.

● Data analysis, Data compilation and TDS preparation, maintaining equipment logbooks, column logbooks and Laboratory notebook.

Hands-on experience on Waters as well as Agilent HPLC system with empower software.