TOC System Suitability Test of USP by Combustion Catalytic Oxidation TOC-VCSH

Introduction

In USP27 (United States pharmacopeia), management of organic impurities in pure water (PW) and water for injection (WFI) is prescribed using total organic carbon (TOC). According to the USP, the TOC analyzer used for analysis must satisfy the requirements of a TOC system suitability test, and detecting levels of 0.05mg/L or less. We introduce here an example of implementation of the TOC system suitability test using the Shimadzu combustion catalytic oxidation type total organic carbon analyzer TOC-VCSH, and a measurement example using a TOC concentration less than 0.05mg/L.

June 16, 2005 GMT