Total Organic Carbon Test

Protheragen-ING Lab is committed to delivering precise and reliable Total Organic Carbon (TOC) data to support your pharmaceutical development and quality control processes. Our team is dedicated to ensuring the highest standards of accuracy and professionalism in every analysis we perform.

TOC in pharmaceuticals

TOC analysis is a crucial parameter in the pharmaceutical industry for assessing the level of organic contamination in water and other solutions. Organic impurities in drug substances, excipients, or water used in manufacturing can pose serious risks if present at high levels, including toxic effects, interference with the active pharmaceutical ingredient, microbial growth, and degradation of the drug product.

TOC analysis works by oxidizing all organic carbon compounds in a sample to CO₂, which is then measured using sensitive detection equipment. This gives a comprehensive assessment of the total organic carbon content, rather than only measuring specific organic compounds.

Our TOC testing methods

We employ several advanced methods for determining the TOC content in pharmaceutical samples:

High-Temperature Combustion Method

This method involves oxidizing organic carbon in the sample at high temperatures to convert it into carbon dioxide, which is then measured using a non-dispersive infrared (NDIR) detector.

Chemical Oxidation Method

This technique uses chemical oxidants to oxidize organic carbon in the sample to carbon dioxide, which is subsequently measured using an NDIR detector.

UV/Persulfate Oxidation Method

This method involves using ultraviolet light and persulfate to oxidize organic carbon in the sample. The resulting carbon dioxide is measured using an NDIR detector.

Conductivity Detection Method

In this method, the sample is oxidized, and the resulting carbon dioxide is converted into carbonic acid, which changes the conductivity of the solution. The change in conductivity is measured to determine the TOC content.

Our TOC testing capabilities

Our pharmaceutical analysis laboratory is equipped with state-of-the-art TOC analyzers and experienced scientists to provide reliable, high-quality TOC testing services, including:

• Determination of TOC in pharmaceutical-grade water.
• Measurement of TOC in drug substances, excipients, and other raw materials.
• TOC analysis of in-process samples during manufacturing.
• TOC testing of final drug product lots.

We follow all relevant pharmacopeia methods (e.g. USP <643>, EP 2.2.44) and industry best practices to ensure accurate, reproducible results you can trust.

With our expertise in TOC testing and commitment to quality, we are the ideal partner to support your pharmaceutical development and manufacturing programs. Contact us today to discuss how we can assist with your TOC analysis requirements.