New Japanese Pharmacopoeia (JP16) Water Testing Requirements

In 2011, the Japanese Pharmacopeia (JP) published changes in the JP 16 monograph that described new analytical testing requirements for Purifed Water (PW) and Water for Injection (WFI). This paper discusses how these changes directly affect the validation of new and existing Total Organic Carbon (TOC) analyzers used for either laboratory or on-line analysis.