ARD

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.

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.