Triclosan...

Triclosan is a broad-spectrum antimicrobial/antibacterial agent which is classified as a Class III drug by the FDA. It is manufactured by Ciba Specialty Chemical Products under their trade names Irgasan and Irgacare. Triclosan (generic) is also produced by a number of other manufacturers outside of the U.S. located in Switzerland, the Netherlands, China, India, South Korea and else­where. As a result of its bacteriostatic activity against a wide range of both gram-negative and gram-positive bacteria, it has found increasing and recent popular use in personal care products, cosmetics, anti- microbial creams, acne treatment, lotions and hand soaps. It is also used as an additive to plastics, polymers, textile and implantable medical devices to give these materials "anti­bacterial properties".

As a result of the potential for the formation of ultra-trace unwanted by-products which can effect the safety and efficacy of Tri­closan, the USP has issued a new monograph, beginning with the issuance of USP 24 , for the specific testing of bulk Triclosan. This monograph details the assay and testing of USP grade Triclosan. In addition to setting product specification standards and pro­cedures to assay the purity and physical identity of USP Triclosan, it also defines the limits and methods of testing for these unwanted ultra-trace by-products, which may be present, by isotope dilution high resolution gas chromatography/ high resolution mass spectrometry (HRGC/HRMS).

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