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:10/11/2017)... ... October 11, 2017 , ... Singh Biotechnology today announced that ... SBT-100, its novel anti-STAT3 (Signal Transducer and Activator of Transcription 3) B VHH13 ... cross the cell membrane and bind intracellular STAT3 and inhibit its function. Dysregulation ...
(Date:10/10/2017)... CA (PRWEB) , ... October ... ... a development-stage cancer-focused pharmaceutical company advancing targeted antibody-drug conjugate (ADC) therapeutics, today ... of targeted HPLN (Hybrid Polymerized Liposomal Nanoparticle), a technology developed in collaboration ...
(Date:10/10/2017)... California (PRWEB) , ... October 10, 2017 , ... Dr. ... speaking at his local San Diego Rotary Club. The event entitled ... Diego, CA and had 300+ attendees. Dr. Harman, DVM, MPVM was joined by ...
(Date:10/10/2017)... , Oct. 10, 2017 SomaGenics announced ... the NIH to develop RealSeq®-SC (Single Cell), expected to ... profiling small RNAs (including microRNAs) from single cells using ... highlights the need to accelerate development of approaches to ... "New techniques for measuring levels of ...
Breaking Biology Technology:
(Date:4/24/2017)... Janice Kephart , former 9/11 ... Partners, LLP (IdSP) , today issues the following ... March 6, 2017 Executive Order: Protecting the ... be instilled with greater confidence, enabling the reactivation ... applications are suspended by until at least July ...
(Date:4/13/2017)... According to a new market research report "Consumer ... Administration, and Authorization), Service, Authentication Type, Deployment Mode, Vertical, and Region - ... to grow from USD 14.30 Billion in 2017 to USD 31.75 Billion ... ... MarketsandMarkets Logo ...
(Date:4/6/2017)... 6, 2017 Forecasts by Product ... Readers, by End-Use (Transportation & Logistics, Government & Public ... & Fossil Generation Facility, Nuclear Power), Industrial, Retail, Business ... Are you looking for a definitive report on ... ...
Breaking Biology News(10 mins):