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Compliant total organic carbon/total nitrogen analysis in pharma

Analytik Jena GmbH+Co. KG
8 Sept 2025

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.

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Process ChemistryProcess chemistry is an important stage of drug development for scaling-up drug production or chemical synthesis reactions. It is useful for optimizing economical and efficient drug production. Process chemistry uses reactors and pump systems as well as reagents, standards and buffers.Quality ControlQuality control is needed in all production processes. Quality control is a monitoring procedure or set of procedures that are put in place to ensure that a manufactured product adheres to a defined set of quality criteria. Ultrapure WaterUltrapure water is the highest purity water and contains the lowest levels of organic and inorganic contaminants, particulates and microorganisms.Water AnalysisAnalytical methods used to test the purity of drinking water include determining the level of contaminants abides to the level set by the Environmental Protection Agency (EPA).PharmaceuticalsPharmaceuticals are medicinal drugs used in healthcare to diagnose, prevent, cure and treat illnesses. Pharmaceuticals that are excreted after use appear in wastewater and can have detrimental effects on the environment.

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Compliant total organic carbon/total nitrogen analysis in pharma