Pharmaceutical Water

Water is one of the key substances in the production of pharmaceuticals, with various grades of quality being required depending on the different pharmaceutical uses. Considerable effort is devoted to the maintenance of water purifications systems and the control of water purity. Both the United States and European Pharmacopoeia have incorporated the Total Organic Carbon (TOC) parameter as an effective process control parameter for water purification and distribution systems, as well as for the packaging of water. The requirements of USP <643> are consistent with EP 2.2.44 in instrument specifications and the need of regular system suitability testing. However, while according to EP the controlled water shall not exceed a concentration of 0,5 mg/L carbon, USP does further distinguish between “bulk water” (0,5 mg/L) and “sterile water” (max. 8.0 mg/L).

When used in the pharmaceutical and semiconductor industries, it is important to continuously control the quality of pure water to keep the impurities at low level. For optimum quality control of ultra-pure water, the online total organic carbon analyzer TOC-1000e enables highly sensitive analysis with a lower detection limit as low as 0.1 μg/L based on the UV oxidation-conductivity measurement method. This article introduces an example of online measurement of ultra-pure water using TOC-1000e.

For water used in pharmaceuticals, the US Pharmacopoeia (USP) specifies that total organic carbon (TOC) should be used for management of organic impurities. According to USP 643 TOC, TOC analyzers to be used for analysis of bulk purified water and water for injection must satisfy the TOC system suitability test using test water with a carbon content of 0.500mg/L. This article introduces an actual example of TOC system suitability testing using the online total organic carbon analyzer TOC-1000e and optional sampler.