What are forced degradation studies?
Here in the following video a step-by-step explanation is given. This provides a brief overview of forced degradation studies, their impact, and their importance in the regulatory submissions of the drug products. This is helpful for the graduate students and industry professionals who want to pursue a career in the field of pharmaceuticals.
This video answers following questions:
What are API impurities?
What are the forced degradation studies?
What is the need for forced degradation studies for the new drug product?
What are the analytical tools required for these studies?
What is the impact of forced degradation studies?
3) Identification, Characterization, Synthesis, and Isolation of API Impurities: A Comprehensive Guide
The synthesis of pharmaceutical impurities and reference standards is essential in the drug manufacturing process and regulatory submissions of the new drug formulations. The API impurities are specifically required for the analytical method developments, understanding the impurity profile of the API. Also, the mutagenic impurities, like nitrosamine impurities, need to be identified and characterized during the regulatory submissions of newly developed drugs.