KSEF R&D Excellence: Deuterated Internal Standards for Equine Forensic Chemistry: A Regulatory Requirement Title of Proposed Project: and a Developing Niche Market

About 46 equine therapeutic medications with potential to affect performance are used by veterinarians in horses in training prior to competitive events. Current analytical testing is highly sensitive; regulators are therefore increasingly forced to accurately quantify residues of therapeutic medications in post-event samples. The need for accurate quantification creates a requirement for deuterated internal standards, as explicitly set forth in the International Laboratory Accreditation Committee (ILAC G-7) "Accreditation Requirements and Operating Criteria for Horseracing Laboratories" (1). Such deuterated internal standards, however, are generally not available to racing chemists. In North America alone, about 500,000 equine samples a year are tested. Use of deuterated internal standards at a rate of one deuterated standard per sample tested, at $50.00/standard, yields a gross annual cash flow of $25M. Any significant fraction of this cash flow represents a scientific and commercial opportunity. We will synthesize and market deuterated internal standards for an increasing number of the 46, more or less, regulated equine therapeutics, beginning with those most commonly regulated in racing. More recently, the drive towards nationally standardized testing has created an immediate requirement for significant quantities of deuterated internal standards for flunixin and ketoprofen. Equine medications for which deuterated internal standards are currently marketed indude phenylbutazone and furosemide; to date, our research group has provided approximately four deuterated internal standards to the racing industry (www.thomastobin.com). but about 42 standards remain to be created, a significant scientific and technical challenge. Since these therapeutics will be used in racing horses for the foreseeable future, and regulatory controls on equine therapeutics in performance events are unlikely to disappear, these circumstances have created a clear market niche for a high-tech Kentucky-based company to address a world-wide regulatory need for Kentucky's signature industry, the performance horse, and the need to optimally regulate their performances.