Demands From Pharmaceutical Operations Drive Development of Chemical Identification

Ahura Scientific, Inc., a leader in rugged, ultra-compact handheld instruments for chemical identification, today announced that it has launched TruScan(TM) 1.2 at INTERPHEX in Montréal, Canada. TruScan 1.2 enables companies to develop new libraries of materials, typically referred to as "methods," from any location and share them via network management software with other TruScan units. In addition, it allows multinational businesses to standardize on a common set of validated methods, maintain a central library of materials by supplier and formulation, and implement more efficient and effective inspection processes.

TruScan is a rugged, handheld Raman system for rapid raw material verification. Since the 2007 launch, TruScan instruments have been sold to seven of the ten largest global pharmaceutical companies. The point-and-shoot optical configuration of TruScan enables material identification and authentication through sealed transparent packages, delivering inspection guidance to the operator in rapid fashion, while minimizing the risk of exposure and contamination.

For molecular spectroscopists, Raman spectroscopy has always been a viable and reliable technique for chemical identification and authentication of materials. With the recent issuance of the USP General Information Chapter on Raman Spectroscopy, and an impending update to a General Tests and Assays chapter, pharmaceutical scientists can now benefit from the inherent advantages of Raman spectroscopy and the flexibility of field-deployed real-time analysis with the TruScan handheld instrument.

"Recognition of the versatility and reliability of Raman spectroscopy by pharmaceutical regulatory bodies validates its use as a platform for the generation and use of pharmaceutically-based spectral libraries on the TruScan instrument for pharmaceutical material (API, excipients, and drug product identification and authentication). I am excited about the possibilities the TruScan platform brings to materials management settings, anti-counterfeit measures, and general use in pharmaceutical research and development," said David E. Bugay, Ph.D., President of PharmAnalysis, Inc., AAPS Fellow, member of the USP General Chapters Expert Committee, and Co-author of "Pharmaceutical Excipients: Characterization by IR, Raman, and NMR Spectroscopy."

Installed TruScan customers can request the base software for TruScan 1.2 upgrade at no cost. With TruScan 1.2, Ahura Scientific will also be offering two new options: an expanded Discovery Library and a Remote Recertification of Calibration package. The Discovery Library includes an updated set of more than 4,000 items of raw materials typically used in brand security and counterfeit assessments. The Recertification package is a remotely-controlled service which ensures users that their TruScan instrument is still within the calibration band of operation, and enables them to receive the annual certification demanded by the majority of cGMP compliant facilities.

"Pharmaceutical companies are under an increasing amount of pressure by the public and by pharmacopeia, such as the USP, EP and JP, and by regulators, such as the U.S. FDA, to do more to ensure the purity and quality of their materials," said Ahura Scientific chairman and CEO Doug Kahn. "At Ahura Scientific, we endeavor to help these customers in their efforts to maintain the safety and confidence of consumers of pharmaceutical and health products throughout the world."

For a demonstration of TruScan 1.2 visit booth #215 at INTERPHEX, taking place at the Palais des Congrès September 24-25 in Montréal, Quebec. Additional information about TruScan can also be found at http://www.ahurascientific.com/TruScan.

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