Water for Injectables
As the foundation for in solution medicines and electrolytes, ultra-pure water is of vital importance to public health and best practice in pharmaceutical manufacturing. Monitoring of total organic carbon (TOC) in this water is required according to USP <643> guidelines. To meet your needs, Shimadzu has designed a compact, network-connected solution that is easy to use and compliance-ready.
With an innovative xenon excimer lamp that includes the oxidation flow path, Shimadzu’s TOC-1000e provides superior irradiation of the sample, minimizes carryover, and prevents ozone generation in the instrument. Users will appreciate the touch screen driven operation at the instrument, as well as integration of results into the LabSolutions platform to enable electronic signature workflows and ensure data integrity.
Whether your TOC measurement needs are testing 4 L of water per day, or 4000 L, Shimadzu has a scalable solution that can prepare you to meet current and future regulatory demands.
Online Measurement of Ultra-pure Water Using TOC-1000e
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.
TOC System Suitability Test Using TOC-1000e According to USP <643>
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.