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Triclosan ia a broad-spectrum antibacterial/antimicrobial 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 manufactures 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 gran-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 monogram, 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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