Pharmaceuticals may sometimes contain unwanted chemicals carried forwarded from synthesis or formed during stability, called pharmaceutical impurities. Even smaller quantities of such impurities negatively influence the effectiveness of the pharma products and also have negative health impacts. Thus, it has proved to be of supreme interest of drug registration authorities to conduct quality analyses, also called impurity profiling, for the components used in drug manufacturing as well as the finished products.
Different types of impurities can occur in pharmaceutical preparations – organic, inorganic and residual solvents. Impurity profiling initially detects the impurities using hyphenated LC, and/or GC MS techniques with knowledge on their structures in order to manipulate the reaction conditions or excipients and avoid such impurity’s formation or at least minimize its concentration to a level of approval. Also, toxicological studies can be conducted with regards to the structural information of the impurities in case of major concentrations of the same.
The upcoming live webinar shall provide in-depth knowledge for the profiling of impurities with a focus on the methodology used.
Date: February 25, 2022 | 3.30-4.30 pm IST
Agenda: 30 mins presentation followed by Q&A session
About the Speaker:
Dr Ravi Shah, Associate Professor, Department of Pharmaceutical Analysis, NIPER – Ahmedabad, India
Dr Ravi received his M.S. (Pharm) and PhD from NIPER, Mohali under the guidance of Prof. Saranjit Singh. Before joining back to academic research, he served at various levels in the industry to understand the needs of the pharma sector. He had started his career with the Biocon-BMS research and development center, where he was responsible for analytical activities related to IND fillings of drug discovery leads. Post drug discovery understanding, he joined Dr Reddy’s in 2015 as associate director and department head for Analytical R&D Bangalore facility to learn generic drug development. He gathered vast experience on product development workflow, and regulatory requirements pertaining to DMF/ ANDA fillings at US and EU. He also worked significantly on complex generics for getting
pharmaceutical equivalence through robust CQA, CPP and CMA correlations through QbD approaches.
Currently, his lab at NIPER Ahmedabad is working on diverse fields of drug development and platform technology developments including impurity profiling, drug-excipient compatibility studies, Dissolution study of Atrigel, impact on dissolution and CQAs through structural changes in biopolymers, biomarker quantification to understand stress etc. His team also supports industries by solving their product development challenges.
Register now and book your seat
In case you are not able to attend the webinar, you shall receive a link to watch it later. So, do not forget to register yourself.
