This course will cover the main aspects related to the control of impurities in drugs and medicines and the application of the USP –NF General Chapter <1086> Impurities and Forced Degradation Studies. The content will consist of forced degradation studies that assist in the identification of the most likely degradation products. Case studies will demonstrate degradation pathways, intrinsic stability of the molecule and validation of the analytical procedures. In addition, the course includes the presentation of the challenges of the Pharmaceutical Industry in forced degradation studies and evaluation of impurities and also the regulatory aspects of these studies, with evaluation of current legislation and regulatory trends for the future. Additional discussions on mutagenic impurities and nitrosamines.
Date: June 14th and 15th, 2022
Couse Duration (hh:mm:ss): 16:00:00
Leonardo Allain – MSD
Mariah Ultramari – Spektra Consultoria
Juçara Ribeiro – ANVISA