Compliant total organic carbon/total nitrogen analysis in pharma

Total organic carbon (TOC) offers a fast, reliable approach for cleaning validation in pharmaceutical quality control. Unlike targeted methods such as HPLC, TOC enables the detection of all organic residues including APIs, excipients, and detergents in a single measurement. Supported by regulatory bodies like the FDA, this method aligns with pharmacopoeia TOC monographs for equipment validation.

In this eBook, Analytik Jena showcases key TOC and total nitrogen (TN) applications using the multi N/C x300 analyzers for ultrapure water testing, cleaning validation, extractables analysis from packaging, and vaccine quality control. Plus, learn how the FDA 21 CFR Part 11 Compliance module of the multiWin pro software can support you to carry out audit-safe and compliant data handling with a server-based central data management.