Overview

The analytical research and development laboratory engaged to Spectroscopic, electrochemical and Chromatographic or miscellaneous analytical method development and validation of drugs products (Parenteral and Oral dosages forms) and drug substances, self-life determination of drugs products (Parenteral and Oral dosages forms).Analytical method development and validation are the continuous and inter-dependent tasks associated with the research and development, quality control and quality assurance departments. Analytical procedures play a critical role in equivalence and risk assessment, management. It helps in the establishment of product-specific acceptance criteria and stability of results. Validation should demonstrate that the analytical procedure is suitable for its intended purpose. The design of the experiment is a powerful tool for method characterization and validation. Analytical professionals should be comfortable to use it to characterize and optimize the analytical method. Effective analytical method development and its validation can provide significant improvements in precision and a reduction in bias errors. It can further help to avoid costly and time-consuming exercises.

Areas Interest

The research interest of the analytical research and development laboratory is support to new product development and Regulatory submission. High-performance liquid chromatography (HPLC) method development and validation, ASSAY, RS and Dissolution testing by HPLC, Residual solvent, organic volatile impurities method development and validation by Gas chromatograph(GC).Stability testing of the products to determine the shelf life. Other spectroscopic and classical methods of analysis.