TOC System Suitability Test for Sterile Water According to USP

Introduction

The United States Pharmacopeia (USP) specifies that total organic carbon (TOC) content be used for management of organic impurity values permitted in bulk purified water, water for injection, in addition to sterile purified water and sterile water for injection. According to USP, TOC analyzers to be used for sterile water must satisfy the TOC system suitability test using test water having a carbon content of 8.0 mg/L, and must also be able to detect TOC at 0.1 mg/L or less. Here, we introduce an actual example of TOC system suitability testing using the Shimadzu TOC-LCPH combustion catalytic oxidation type analyzer.

January 29, 2015 GMT