Agilent Technologies Introduces Mechanical Qualification System for Dissolution Testing

Santa Clara, CA—May 2012—Agilent Technologies, Inc., (NYSE: A) introduced the 280-DS Mechanical Qualification System, a new instrument for routine and effortless cali-bration of a dissolution apparatus. The 280-DS accurately measures, verifies, and documents physical parameters es-tablished with recently enhanced mechanical qualification standards, eliminating the need for visual interpretation of measurements from manual gauges.

Dissolution is a technique used in the pharmaceutical in-dustry to determine the rate at which active pharmaceutical ingredients release from solid dosage forms such as tablets and capsules. The 280-DS Mechanical Qualification System, with its 280-DS Workstation Software, redefines dissolution qualification with optical-sensing technology that delivers virtually hands-free measurements in seconds.

ìPharmaceutical customers now have one instrument that supports whichever type of qualification their dissolu-tion laboratories require,î said Allan Little, Agilent director of marketing for dissolution systems. ìThe 280-DS precise-ly measures the critical parameters required for qualifica-tion in a fraction of the time it used to take. Efficiency, time savings, accuracy, and documentation are all realized with this instrument.î

The 280-DS Mechanical Qualification System supports traditional and enhanced qualification methods to meet current Good Manufacturing Practices (cGMP). Whether the laboratory uses the U.S. Pharmacopeiaís Performance Verification Test (PVT) or the U.S. Food and Drug Admin-istration and American Society for Testing and Materials (ASTM) Enhanced Mechanical Qualification standards, the 280-DS offers unprecedented measurement capabilities.

The 280-DS enables users to:

• Qualify any dissolution apparatus that has an open-head design, including Agilentís 708-DS and 709-DS.
• Obtain accurate, precise, and repeatable measurements with limited hands-on interaction using optical sensors and the 280-DS Workstation Software.
• Determine quantitative values for each parameter with data recorded and stored in 21 CFR Part 11-compliant software.
• Track physical performance data of the dissolution appa-ratus over time in order to maintain the apparatus in top mechanical condition.

For more information, please visit agilent.com/lifesciences/280-DS.

About Agilent Technologies

Agilent Technologies Inc. (NYSE: A) is the worldís pre-mier measurement company and a technology leader in chemical analysis, life sciences, electronics, and communi-cations. The companyís 18,700 employees serve custom-ers in more than 100 countries. Agilent had net revenues of $6.6 billion in fiscal 2011. Information about Agilent is available at www.agilent.com.

Eric Endicott
+1 408 553 2005
eric_endicott@agilent.com

Vertical Diffusion Cell Testing

Los Angeles, CA—June 2012—Hanson Research, a leader in dissolution test technology, has expanded its product line of Vertical Diffusion Cell (VDC) in-struments for the quality testing of semisolids and transdermal delivery systems. Proposed USPGeneral Chapters <3> Topical and Transdermal Drug Products Product Quality Tests (USP PF 36/6) and <1724> Semisolid Drug Products—Performance Tests (USP PF 38/3) detail the requirements for testing creams, gels, ointments, suspensions, lotions, and other relevant dosage forms.

Hanson systems include:

• Vertical Diffusion Cells (VDCs) with select dosage areas and receptor volumes
• Ability to accommodate various semisolids, membranes, and media
• Cells for special dosage formulations, ophthalmics, and cosmetics
• Special application cells and tops for fiber optics and iontophoresis studies
• 6-Cell Manual Diffusion Cell systems for startup labs
• Fully automated systems with the Hanson MicroettePlus
• Sales, service, and support worldwide

Contact
Roy Hanson
CEO
Hanson Research Corporation
T. 818.882.7266 x215
F. 818.882.9470
rhanson@hansonresearch.com
hansonresearch.com

New company announcement: Tergus Pharma

Analytical Solutions, Inc. Expands, Changing Name to Tergus Pharma New Name Reflects Expanded Services in Dermatology Product Development

Research Triangle Park, NC—June 12, 2012—In response to company growth and expansion of topical pharmaceu-tical product development services, Analytical Solutions, Inc. (ASI) is pleased to announce today that it is changing its name to Tergus Pharma, LLC, to better echo the com-panyís new growth trajectory.

Tergus Co-Founder and CEO, Dr. Vijendra Nalamothu, most recently Head of Dermatology R&D for Promius Phar-ma and Dr. Reddyís Laboratories, brings 18 years of topical drug product development and commercialization experi-ence to Tergus clients. Since 1994, Tergus Co-Founder and President, Dr. Kailas Thakker, has been providing quality analytical services to the pharmaceutical industry with an emphasis on In Vitro Release Testing (IVRT), functional testing for semisolids and topical products.

Tergus (Latin for ìskinî) is now providing dermatology drug development services from concept to commer-cialization. With the acquisition of new equipment and strategic additions to the scientific team, Tergus Pharma is pleased to announce that it is now servicing its cli-ents with a broader range of topical drug development services, including product development strategy and design; target product profile development; formula-tion development; analytical method development and validation; preclinical and clinical supplies manufacturing; program management and logistics leadership; scale-up and technology transfer oversight; regulatory CMC con-sulting; disease model development; clinical development strategy; and development plan creation to ensure fastest path to in vivo or clinical proof-of-concept studies.

Tergusí core expertise will remain focused in topi-cal dosage forms including creams, ointments, lotions, liquids, suspensions, gels, hydrogels, pastes, pump sprays, topical aerosols, foams, microencapsulation, liposomes, suppositories, and nail lacquers.

About Tergus Pharma

Tergus Pharma, LLC, is a privately held dermatology-focused organization offering complete pharmaceutical product development services. Tergusí GMP/GLP-compli-ant, state-of-the-art laboratories are located in Research Triangle Park, North Carolina. For additional information, please visit www.TergusPharma.com.

Think Topicals. Think Tergus
Contact
Ms. Kathy Meserve
Director, Business Development
KMeserve@TergusPharma.com
+1 (919) 549-9700 Ext. 105

SOTAX Launches New Device for Enhanced Mechanical Calibration of Dissolution Testers

SOTAX MQD for enhanced mechanical calibration of dissolution testers

July 2012—More and more people in the pharmaceutical industry are adopting the new regulatory guidelines for enhanced mechanical calibration of dissolution systems. To improve and simplify the implementation of the enhanced mechanical calibration, SOTAX is pleased to announce the SOTAX MQD, a new universal tool for qualification of all brands of USP 1 and 2 dissolution testers.

The SOTAX MQD serves to simplify data capture and re-porting while meeting industry compliance requirements. It wirelessly communicates with the intuitive software and guides the user through a simple step-by-step protocol to complete the qualification. By reducing user interpreta-tion of manual readings along with the automated PDF report, the MQD allows for efficient calibrations with reliably precise data.

The fully NIST traceable MQD also simplifies the overall qualification workflow as the user only needs this one tool for calibration of any dissolution tester, regardless of brand (USP 1 and 2), and therefore eliminates the need for complex tool sets.

The SOTAX MQD will be presented at AAPS in Chicago on booth #4027.

The SOTAX Group is an international leader in the development and manufacturing of pharmaceutical testing equipment. With a global network of service engineers, the company is also a trusted provider of installation, maintenance, repair, and qualifica-tion services for its SOTAX and Zymark brand products.

Press Contact:
Contact: Petra Silbereisen
Phone: +41 61 487 54 20
Fax: +41 61 482 13 31
Email: info@sotax.com

SOTAX AG
Binningerstrasse 106
4123 Allschwil
Switzerland