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Cerilliant Introduces New Certified Spiking Solution® and Snap-N-Spike® Reference Standards of Tapentadol Metabolites
ROUND ROCK, TEXAS - January 24, 2011 - Cerilliant introduces the first certified reference standards of N-Desmethyltapentadol, Tapentadol-β-D-glucuronide and Tapentadol-O-sulfate, the primary and secondary urinary metabolites of Tapentadol, in Cerilliant accurate and convenient Snap-N-Spike® format.
Tapentadol, sold under the brand name NUCYNTA®, was introduced June 23, 2009, in the United States for the FDA-approved treatment of moderate to severe acute pain. It was the first new drug of the centrally-acting analgesic class approved in the United States in more than 25 years. More than 25 million Americans experience acute pain each year as a result of injuries or surgery, and acute pain is the most common reason people seek medical attention. Tapentadol and its metabolites are classified as Schedule II substances under the Controlled Substances Act.
These new certified reference standards provide laboratories with a full panel of Tapentadol metabolite standards for their applications and testing methods. Cerilliant has received DEA exemptions and Health Canada Test Kit numbers for these new Certified Spiking Solutions® allowing laboratories in the USA and Canada to order them without time consuming regulatory paperwork.
"For every new pain management drug being prescribed there is a need for high quality certified reference standards," comments Mitzi Rettinger, Vice President of Cerilliant. "Our convenient Certified Spiking Solutions® enable laboratories to provide accurate analytical results critical to drug monitoring programs while maintaining efficiency."
The company also announced that a deuterium-labeled internal standard of Tapentadol-β-D-glucuronide is coming soon to assist laboratories in quantitation of glucuronide levels in samples without the need for hydrolysis.
Cerilliant's Tapentadol reference standards, which also include the parent drug and its deuterium-labeled internal standard, are manufactured and certified to the highest industry standards including ISO Guide 34 and ISO/IEC 17025 and are suitable for quantitative or qualitative applications including pain prescription monitoring, toxicology applications, or urine drug testing. These standards are classified as Certified Reference Materials in accordance with ISO requirements. Cerilliant's quality system also incorporates FDA's cGMP and GLP guidelines as well as ISO 9001:2008 requirements making these standards suitable for analytical application across international borders.
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