INTRODUCTION

Total organic carbon (TOC) is an indirect measure of organic molecules present in pharmaceutical waters measured as carbon. Organic molecules are introduced into the water from the source water, from purification and distribution system materials, from biofilm growing in the system, and from the packaging of sterile and nonsterile waters. TOC also can be used as a process control attribute to monitor the performance of unit operations comprising the purification and distribution system. A TOC measurement is not a replacement test for endotoxin or microbiological control. Although there can be a qualitative relationship between a food source (TOC) and microbiological activity, there is no direct numerical correlation.