Applications for TOC
Testing of plastic packaging systems and their materials according to USP 661 using the TOC method
In the pharmaceutical industry plastic packaging is used in various forms – for example for intravenous gabs, bottles, cartridges or pre-filled syringes. The United States Pharmacopeia requires testing those packaging for suitability for their particular use. USP chapter 661.1 describes the characterization and testing of the individual plastics materials used to manufacture the packaging, while USP chapter 661.2 deals with required testing of the assembled packaging. Characterization takes place by identifying and determining bio-compatibility, physio-chemical characteristics and extractable metals. The parameter Total Organic Carbon (TOC) as an indicator for extractable organic material is part of the physio-chemical characteristics that must be monitored.
TOC – Determination according to USP 643
In 1996, the US Pharmacopeia has introduced the TOC parameter for the determination of impurities in purified water and water for injections. For other waters used in the pharmaceutical industry, the wetchemical potassium permanganate test continued to be used. Meanwhile however, TOC determination has proven to be so effective that it now replaces the wetchemical test.