TOC System Suitability Test Using TOC-1000e According to USP 643

Introduction

For water used in pharmaceuticals, the US Pharmacopoeia (USP) specifies that total organic carbon (TOC) should be used for management of organic impurities. According to USP 643 TOC, TOC analyzers to be used for analysis of bulk purified water and water for injection must satisfy the TOC system suitability test using test water with a carbon content of 0.500 mg/L. This article introduces an actual example of TOC system suitability testing using the online total organic carbon analyzer TOC-1000e and optional sampler.

October 27, 2020 GMT