Company has announced a new method for detecting melamine in pharmaceutical products that uses LC/MS/MS to provide greater sensitivity and specificity over other techniques. Company’s new method meets the FDA’s August 2009 guidance, entitled Pharmaceutical Components at Risk for Melamine Contamination, which identifies raw materials that are considered high-risk for melamine contamination and recommends monitoring of these raw materials for the presence of melamine prior to release into production. Company’s method has been validated for each individual raw material listed in the guidance document. Matrix specific preparations and sensitivity limits for each raw material have been established. Melamine is used in the manufacture of a variety of products, including resin based products (countertops, glues, house-wares, etc.), cleaning products and industrial cleaners. Melamine has a low acute toxicity and is not readily metabolized. Cyanuric acid, which also has a low acute toxicity, is a structural analogue of melamine and is used in the manufacture of herbicides, dyes, resins and antimicrobial agents. It is also used as a stabilizer and disinfectant in swimming pools and as a component of feed grade biuret (a ruminant feed additive). The combined presence of melamine and cyanuric acid leads to the formation of melamine cyanurate. This compound has low solubility which can lead to the formation of crystals in the kidneys, a condition known to cause renal failure, kidney toxicity and, in some subjects, death.
INTERPHEX Puerto Rico Booth No. 1130
Lancaster Laboratories, Inc.
2425 New Holland Pike
Lancaster, PA, 17601