Application Note

Analysis of SiO2- and TiO2-Containing Medications by ICP-OES per USP 232/233 with Software to Aid in 21 CFR Part 11 Compliance


Since early 2018, manufacturers of pharmaceutical products are mandated to comply with USP <232/<233> requirements around the analysis of elemental impurities in medications. This work demonstrates the ability of PerkinElmer’s Avio® 220 Max hybrid simultaneous ICP-OES to pass validation testing for Class 1 and 2A elements for USP <232>/<233> methodology, while allowing labs to comply with 21 CFR Part 11.