EP 2.2.44 Total Organic Carbon in Water for Pharmaceutical Use

EP 2.2.44 is a standard that outlines a test method for determining the total organic carbon (TOC) in water used for pharmaceutical purposes. This method involves measuring the amount of organic carbon present in water by oxidizing the organic molecules to carbon dioxide and then quantifying the carbon dioxide produced. The standard applies to highly purified water, including water for injection (WFI) and purified water (PW), and is crucial for ensuring the quality and safety of these pharmaceutical products.

TOC is an indirect measure of organic substances present in water, which can include contaminants that may affect the quality and safety. High levels of organic carbon can indicate contamination from organic compounds, which can lead to the formation of harmful by-products during pharmaceutical manufacturing processes. Such substances are particularly critical, when contained in water for injection (WFI). Therefore, accurately measuring TOC is vital for maintaining the purity and quality of water used in pharmaceutical applications.

EP 2.2.44 provides precise and reliable measurements of TOC, which are critical for the pharmaceutical industry. By using methods that ensure complete oxidation of organic contaminants to carbon dioxide, the standard ensures high sensitivity and accuracy in detecting trace levels of organic carbon. This method also helps in maintaining the efficiency of pharmaceutical manufacturing processes, protecting product quality, and ensuring patient safety. Consequently, EP 2.2.44 plays a vital role in the economic and operational aspects of the pharmaceutical industry. 

The standard also emphasizes the importance of system suitability and calibration. It recommends using a calibrated instrument, either on-line or off-line, and verifying system suitability at suitable intervals. The apparatus used must have a limit of detection specified by the manufacturer of 0.05 mg or less of carbon per liter. Additionally, the standard highlights the need for proper glassware preparation to avoid contamination, using highly purified water for the final rinse of glassware.

EP 2.2.44 allows for flexibility in the choice of methods for TOC determination, which clearly discriminates between organic and inorganic carbon. The differentiation can be achieved either by subtraction of the measured inorganic carbon from total carbon or by purging the inorganic carbon from the sample before direct TOC (NPOC) measurement. It is emphasized that purgeable organic carbon is present in negligible quantities in water for pharmaceutical use and therefore NPOC results can be set equal to TOC results. 

With more than 30 years of experience in TOC analysis Analytik Jena offers customized solutions and expertise for the pharmaceutical industry. With the multi N/C x300 series, we offer a range of high-quality and reliable TOC analyzers following either the high-temperature catalytic oxidation or the UV/wet-chemical sample digestion principle combined with sensitive and selective CO₂ quantification by NDIR (non-dispersive infrared) detection principle. The devices not only meet the requirements of EP 2.2.44, they also fulfill the requirements of USP <643>, JP 2.59 and KP. They also come along with full FDA 21 CFR Part 11 and data integrity compliance. 

Our solutions for EP 2.2.44

Sources

• EP 2.2.44: Total Organic Carbon in Water for Pharmaceutical Use.