Significant revisions to the standards for residual solvents found in USP General Chapter─NF <467> Residual Solvents became official March 1, 2019. At the same time, the companion USP chapter <1467> Residual Solvents – Compendial Procedures Verification 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 methyl isobutyl ketone from a residual Class 3 solvent to a residual Class 2 solvent and added triethylamine as a new Class 3 residual solvent. Other related topics will be discussed, including residual solvent test validation and verification as described in USP <1467>.
Date: November 8th and 10th, 2022
Couse Duration (hh:mm:ss): 08:00:00
Pedro López García, Ph.D – Consultant, Specialist in Residual Solvents
Mônica Piovanni – Specialist in Products and Applications, Thermo Fischer