European Pharmacopoeia EP 2.2.44 and Total Organic CarbonThis paper discusses the background behind the European Pharmacopoeia’s focus on complete oxidation of TOC in the light of the increased importance of on-line Total Organic Carbon (TOC) and conductivity measurement.
21 CFR Part 11 Data Integrity for On-line WFI InstrumentsThis application note takes a look at how quality-critical on-line Total Organic Carbon (TOC) and conductivity instrumentation for WFI (water for injection) quality control can be configured to help companies comply with the FDA’s expectations on data integrity, including the use of Microsoft Active Directory and PDF data export.
Validation of On-line Total Organic Carbon Analysers for Release Testing Using ICH Q2This paper discusses how characteristics for consideration during the validation of analytical procedures may be applied to on-line Total Organic Carbon (TOC) analysers to enable them to be used to provide release test data for Water for Injection (WFI) and Purified Water (PW).
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