Navigation Links
Microtest Laboratories is an Industry Leader in ICH Stability Testing
Date:5/26/2009

AGAWAM, Mass., May 26 /PRNewswire/ -- 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 degrees Celsius -- 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 (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.

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.

Available Topic Expert(s): For information on the listed expert(s), click appropriate link.

Steve Richter, Ph.D.

https://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=42622


'/>"/>
SOURCE Microtest Laboratories
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Microtest Labs Adds Dissolution Testing to its Suite of Analytical and Stability Testing Services
2. Microtest Labs Expands Clean Room, Contamination Testing Services
3. Microtest Labs Adds Dissolution Testing to its Suite of Analytical and Stability Testing Services
4. Microtest Labs Offers Free Microbial Identification Testing, Free Shipping on Other Tests, to MD&M West Attendees
5. Microtest Labs Doubles Microbial Identification, Analytical Services
6. Microtest Offers Free White Paper: Virus Testing for Biological Products: Partnering With a Contract Lab
7. Dr. Chris Huber Joins Asymchem Laboratories Inc. as Director of Chemical Development
8. Charleston Laboratories, Inc. Completes Exploratory Bioequivalence Study of CL-108
9. AIT Laboratories Announces Name, Brand Identity for New Division
10. Roxane Laboratories, Inc. Announces the Launch of Mycophenolate Mofetil 250mg Capsules and 500mg Tablets
11. Virco Lab, Inc. Enters Into Collaboration with SmartGene, Inc. Enhancing HIV Resistance Test Services for Laboratories and Physicians
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... , ... December 01, 2016 , ... ... long-term client Nanowear on their recent FDA Class II 510(k) clearance for their ... significant hurdle in commercializing remote cardiac monitoring devices that rely on cloth-based nanosensors. ...
(Date:12/2/2016)... bioLytical Laboratories, a world leader in rapid infectious disease tests, introduced the Company,s newest ... members. (Photo: http://photos.prnewswire.com/prnh/20161201/444905 ) Continue Reading ... ... , , bioLytical was invited ... introduce the INSTI HIV Self Test to 350 pharmacy representatives in Nairobi ...
(Date:11/30/2016)... Nov. 30, 2016 Biotest Pharmaceuticals Corporation (BPC), ... to announce the addition of its newest plasma collection ... Nebraska . The 15,200 square foot state-of-the-art facility ... 2016 and brings the total number of BPC,s plasma ... Carlisle , BPC,s Chief Executive Officer said "We are ...
(Date:11/30/2016)... November 2016   Merck , ein ... Unterzeichnung einer Reihe von Vereinbarungen mit Evotec ... AG Screeningleistungen für Mercks Palette genetischer Reagenzien ... auf diese Bibliotheken in Kombination mit Evotecs ... Weg zur Ermittlung und Erforschung neuer Arzneimitteltargets.    ...
Breaking Biology Technology:
(Date:11/29/2016)... CANNES, France , November 29, 2016 Nearly ... Continue Reading ... ... System is part of an efficient Identity Management. (PRNewsFoto/DERMALOG Identification Systems) ... DERMALOG is Germany's largest Multi-Biometric ...
(Date:11/21/2016)... Nov. 21, 2016   Neurotechnology , a ... technologies, today announced that the MegaMatcher On Card ... submitted for the NIST Minutiae Interoperability Exchange ... the mandatory steps of the evaluation protocol. ... continuing test of fingerprint templates used to establish ...
(Date:11/15/2016)... 2016  Synthetic Biologics, Inc. (NYSE MKT: SYN), ... the gut microbiome, today announced the pricing of ... its common stock and warrants to purchase 50,000,000 ... to the public of $1.00 per share and ... the offering, excluding the proceeds, if any from ...
Breaking Biology News(10 mins):