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Application Note

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

Introduction

This work demonstrates the ability of the Avio 200 ICP-OES to meet the USP <232>/<233> criteria for Class 1 and 2A elements in tablets containing TiO2 or SiO2 as excipients using Syngistix for ICP Enhanced Security software version 4.0 for 21 CFR Part 11 compliance.