Shimadzu?s TOC-V series covers all water quality analysis requirements. Two systems within this series are particularly suitable for TOC analysis in pharmaceutical applications.
Shimadzu's TOC-V series covers all water quality analysis requirements. Two systems within this series are particularly suitable for TOC analysis in pharmaceutical applications. Both offer a wide measuring range of 0.5 µg/L up to 25.000 mg/L and support a broad variety of applications - from ultra-pure water up to higher concentrations, e.g. in cleaning validation. The two TOC analyzers for ultra-pure water analysis differ in their different oxidation techniques. The TOC-VWP/WS uses wet-chemical oxidation whereas the TOC-VCPH applies the catalytic oxidation method at 680 °C. The solid module SSM-5000A allows measuring of the swabs of cleaning validation directly without extraction.
TOC in pharmaceutical application
Ultra-pure water is one of the most widely used excipients in the manufacturing of drugs. Furthermore, it is also used for cleaning purposes. Different application areas therefore require different grades of pure water. The European Pharmacopoeia (EP) defines several grades of pure water quality: purified water, highly purified water, and water of injection. Purified water is used for the production of drugs that do not require a separate standard. The organic content is determined via the TOC value (0.5 mg/L) or the permanganate test. Highly purified water is sterile water for the production of drugs that do not require 'Water for Injection'. Its TOC content may not exceed 0.5 mg/L. Water for injection is ultra-pure water that is used for the preparation of injection solutions. Its TOC content may not exceed 0.5 mg/L.
TOC determination has already been proven to be verifiable in cleaning validation projects. It is an economical and fast procedure for testing the effectiveness and integrity of cleaning procedures as well as of equipment and machines. Carbon is the common element of all organic compounds. It is present in active agents, inactive ingredients, degradation products, contaminants or cleaning solution.
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