Application Note

Analysis of Allergy Medications by ICP-OES Following USP 232/233 Guidelines with Software to Aid in 21 CFR Part 11 Compliance


With the implementation of USP <232>/<233> for the analysis of elemental impurities in finished drug products, it is important for manufacturers to monitor the metal content of the final products to be in compliance. This work demonstrates the ability of PerkinElmer’s Avio® 550 Max fully simultaneous ICP-OES to pass validation testing for Class 1, 2, and 3 elements for USP <232>/<233> methodology, while allowing labs to comply with 21 CFR Part 11.