Many current on-line TOC technologies may easily pass US or European pharmacopoeia requirements, but not the more challenging JP tests.

JP 16 Water Testing Requirements

On April 1, 2011, the Japanese Pharmacopeia (JP) published changes in the JP 16 monograph that described new analytical testing requirements for Purified Water (PW) and Water for Injection (WFI). These changes directly affect the validation of new and existing Total Organic Carbon (TOC) analyzers used for either laboratory or on-line TOC analysis.

The deadline for complying with these new Japanese Pharmacopoeia (JP16) requirements was September 30, 2012.

JP 16 Impact on Total Organic Carbon (TOC) Analyzer Validation

Are your on-line TOC instruments compliant?

Learn More About JP 16 Compliance

Non-compliance can result in product shipment delays, investigations and negative publicity. Contact us to learn more about how this new regulation affects you and what you can do to comply.