Industry News August 2008

Press Release: June, 2008

LEAP Technologies Incorporated, manufacturer of the OPT-DISS™ and the ARCH™ Probe, has launched the OD Lite™, a lower-cost UV Fiber-Optic Spectrometer.

LEAP Technologies has launched the OD Lite to expand its spectroscopy line and appeal to all budgets. The new system incorporates a chip format that is more common and less expensive to produce. The OD Lite™ meets all of the stringent criteria of the OPT-DISS™ and can monitor up to eight channels simultaneously within the UV range of 200�420 nm. It utilizes the latest version of the stable OPT-DISS™ software, making a seamless integration with existing OPT-DISS™ systems. Together with the patented ARCH™ Probe, the OD Lite™ makes for a new lower-cost system, which is more appealing in times of budget cuts, when the desire to increase the return on investments is paramount.

UV Fiber Optics has made an impact on the way many companies now develop formulations and methods. The reduction of complexity, the benefit of semi-automation, and the lowered potential for error have all made the technique very appealing. With the increase in extended-release, modified-release, and complex delivery systems, UVFO has matured as an analytical technique.

About LEAP Technologies, Inc.
LEAP, based in Carrboro NC, has been providing laboratory automation solutions since 1989. LEAP was one of the first pioneers of the UVFO technique and has been providing commercially available systems since 1998. We thank our customers and partners for the success of our spectroscopy product line.

Contact:
Eric W. Wethington
Managing Director, Pharmtec
LEAP Technologies, Inc.
800-229-8814


SOTAX offers Mechanical Qualification (MQ) Services and new MQ Validation Checkset

Basel, Switzerland, June 1, 2008 - SOTAX, leader in Dissolution Testing Systems and Dissolution Maintenance and Qualification Services, has now added the new Mechanical Qualification Procedure, as described in ASTM E 2503-7, to our offerings.

In October 2007 the FDA issued draft guidance supporting the mechanical validation of dissolution apparatus using the Center for Drug Evaluation and Research (CDER) procedure document on mechanical qualification. At the request of our customers throughout the world, SOTAX can now assist customers who may choose to implement Mechanical Qualification (MQ) of dissolution Apparatus 1 and 2.

The MQ procedure involves the physical measurement and reporting of critical parameters such as paddle and basket wobble, shaft verticality, shaft depth, rotational speed, vessel centering and verticality, bath levelness, and vessel temperature. All SOTAX calibration tools are digital and are certified to NIST traceability. The new SOTAX MQ Validation Checkset is also available for those labs that perform their own qualifications.

SOTAX will continue to offer Performance Qualification (PQ) Services utilizing the USP Performance Verification Test method with prednisone and salicylic acid tablets. A useful strategy to implement the new MQ in your lab would involve the MQ (quarterly or biannually) with the PQ (biannually or annually).

For more details on how SOTAX can assist you in implementing the MQ and our new MQ Validation Checkset, please contact us at services@sotax.com