Microtest Laboratories Provides ICH Stability Testing to Pharmaceutical Product Manufacturers

AGAWAM, MASS. – May 26, 2009 –Microtest Laboratories is an industry leader in providing ICH stability testing, compliant with International Conference of Harmonisation (ICH) guidelines, to manufacturers of pharmaceuticals products. The testing is offered as part of Microtest’s complete portfolio of contract manufacturing testing services.

Before a drug product is submitted for regulatory approval, ICH stability testing helps demonstrate that the product will continue to be safe and efficacious for its stated shelf life. Real-time ICH stability testing is conducted at room temperatures to reproduce actual storage conditions. Accelerated stability testing occurs at higher temperatures — up to 55°C — to simulate longer spans.

Microtest typically tests three conformance lots, to some target of 6, 9, 12, 18, or 24 months. Total elapsed time of all testing is usually 1 year or less. Microtest conducts tests for sterility, endotoxins, and particulates. Microtest also checks that the concentration of active ingredients is within specifications, and watch for evidence that real-time or accelerated aging has affected drug concentration or purity. Moreover, Microtest is one of a few labs that offer photostability testing to monitor the effect of prolonged light exposure.

“Unlike some other labs, at Microtest advanced SCADA systems monitor test chambers 24 hours a day, 7 days a week. So customers and regulators can be sure humidity and temperature remain within prescribed ranges,” said Steven Richter, Ph. D., President and Scientific Founder of Microtest Laboratories (http://www.microtestlabs.com/). “And since we offer a full range of drug testing at a single source, products aren’t exposed to temperature or humidity hazards in transit between tests.”

Microtest is widely recognized for its problem-solving expertise in pharmaceutical contract manufacturing, aseptic processing, and pharmaceutical packaging. Services include single-source production and testing, plus dedicated product management.

For more information, visit Microtest Laboratories on the Web at www.microtestlabs.com/aseptic-processing/stabilty, or call 1-800-631-1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/

Microtest Labs Adds Dissolution Testing to its Suite of Analytical and Stability Testing Services

AGAWAM, MASS. – May 14, 2009 – Microtest Laboratories, a leading single source provider of contract analytical solutions, is adding dissolution testing to its current suite of analytical testing and stability services.

“The addition of dissolution testing is the perfect complement to our portfolio of services,” said Steven Richter, Ph. D., President and Scientific Founder of Microtest Laboratories (www.microtestlabs.com). “By offering an even more comprehensive array of assays, we’re increasing the convenience, efficiency, and value that we deliver as a single, preferred provider of contract laboratory services.”

Dissolution is a compendial method used to measure a drug’s rate of release from its dosage form. It is a complement to other analytical assays – potency and related substances (Microtest already offers both) – that characterize the dosage form.

Dissolution is typically used:

• To optimize drug delivery rate during development studies
• For use in routine QC analysis for lot release and to measure lot-to-lot variability
• For use in stability studies to study the effects of time/temperature/humidity on the dosage form
• To compare one dosage form to another (different formulations, different processes, analysis of competitor's samples)
• To estimate release and absorption rates in humans after an in vitro - in vivo correlation is established
• Dissolution is a sample preparation technique. Samples still need to be analyzed separately, usually by Microtest’s HPLC or UV Spectroscopy testing. Typical samples are oral dosage forms, although it can also be used on topicals and transdermal systems.

In addition to dissolution testing, Microtest provides a host of analytical assays, including HPLC Assays, GC Analysis, Protein Analysis, FTIR Analysis, and UV/VIS Analysis.

Microtest’s analytical testing processes follow guidelines from all major standards authorities, including the United States Pharmacopeia (USP), the Japanese and European Pharmacopoeias, the U.S. Food and Drug Administration (FDA), the International Organization for Standardization (ISO), and the Association for Advancement of Medical Instrumentation (AAMI).

For more information, visit the Microtest website at www.microtestlabs.com/analytical-chemistry-testing or call 1-800-631-1680.

Or, visit Microtest at the 2009 Bio International Convention in Atlanta, May 18th-21st, in Booth 2803 in the Massachusetts Pavilion.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Public Relations contact: Tiziani Whitmyre Inc. (www.tizinc.com/services/public-relations/index.html)

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