Significant revisions to standards for residual solvents found in USP─NF General Chapter <467> Residual Solvents became official on March 1, 2019. At the same time, the companion USP chapter <1467>, Residual Solvents-Verification of Compendial Procedures and Validation of Alternative Procedures became official. Additional revisions were made to USP <467> and became official on December 1, 2020 to align with ICH Q3C(R6) which reclassified methylisobutylketone from a Class 3 to a Class 2 residual solvent and added triethylamine as a new Class 3 residual solvent. These changes continue to impact the industry.
In this one-day course, both compendial and regulatory aspects will be covered. Additionally, different options and control strategies for meeting residual solvents requirements will be discussed. Different approaches may be used depending on if solvents that are present are likely to be known or not. The verification and validation criteria described in USP <1467> will be discussed as well. Other related topics including USP chapters <1225> Validation of Compendial Procedures, <1226> Verification of Compendial Procedures, and system suitability requirement and adjustment based on <621> Chromatography will also be covered. Furthermore, the most recent Pharmacopeial Forum revision proposal and comparison of USP and European Pharmacopeia procedures for residual solvent determination will briefly be described.
Couse Duration (hh:mm:ss): 01:00:00
Pedro López García, Ph.D
M.Sc., Ph.D. Fármaco e Medicamentos, Universidade de São Paulo