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
'/>"/>

SOURCE Microtest Laboratories
Copyright©2009 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2

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:11/20/2009)...OCKVILLE, Md., Nov. 20 N... it has priced an underwritten public offering of ... the public of $3.30 per share. The approximately...underwriting discounts and commissions, will be us...our VLP-based vaccines, internal research and deve...
(Date:11/20/2009)... METTLER TOLEDO recently announced that...r, “The Role of Process Analytical Technolog...dquo; on December 1, 2009. , ...ole of Process Analytical Technology (PAT) in Gree...mber 1, Process Analytical Technology (PAT) case s...
(Date:11/19/2009)...UVELT, N.Y., Nov. 19 Dr. Mate Hidv...ct, responds to a press release issued on November...company for making false and self-serving statemen... ,, Dr. Hidvegi stated from his office in Buda...esearch on Avemar does not apply to AveULTRA, ww...
(Date:11/19/2009)... MALVERN, Pa. and WALTHAM, Mass., Nov. 19 /PRNewsw...sion Resources find that the leading driver of ant...e is broad-spectrum activity against gram-positive...f organisms that can cause nosocomial pneumonia, s...primarily for agents that provide appropriate cove...
Breaking Biology Technology:Novavax Prices Public Offering of Common Stock 2Process Analytical Technology (PAT) in Green Chemistry and Green Engineering 2American BioSciences Rebuts Misleading Statements Made by Hungarian Competitor 2Broad-Spectrum Antibacterial Activity is the Most Important Driver of Antibiotic Selection for Nosocomial Pneumonia In Europe 2Broad-Spectrum Antibacterial Activity is the Most Important Driver of Antibiotic Selection for Nosocomial Pneumonia In Europe 3
...Pioneering medical device company Signostics annou...Food and Drug Administration (FDA) for its palm-si... (Photo: http://www.newscom.com/cgi-bin/prnh/2009...t-effective device that for the first time makes i...o use ultrasound in their clinical practice. Just ...
...otek,s Commitment to the Development of Farletuzum...nza,s Ability to Offer Specialty Development and M...Switzerland, May 19 Morphotek(R), Inc., a subsidi...za Group Ltd jointly announced today that they hav...upport the development and manufacturing of a subs...
...utic for IBD with Novel Mode of Action , , MOUNTA...ay announced that data from the company,s PROTECT-...ion in Crohn,s disease Trial) Phase II/III clinica...with moderate-to-severe Crohn,s disease will be pr...gestive Disease Week (DDW) meeting. Traficet-EN i...
Other Biology Technology:Signostics Receives FDA Clearance for World's Smallest Ultrasound Product 2Morphotek(R), Inc and Lonza Group Ltd Enter Into Manufacturing Services Agreement 2Morphotek(R), Inc and Lonza Group Ltd Enter Into Manufacturing Services Agreement 3Morphotek(R), Inc and Lonza Group Ltd Enter Into Manufacturing Services Agreement 4ChemoCentryx's Traficet-EN(TM) Phase II/III Induction Phase Data in Crohn's Disease to be Featured in Oral Presentation at 2009 Digestive Disease Week 2ChemoCentryx's Traficet-EN(TM) Phase II/III Induction Phase Data in Crohn's Disease to be Featured in Oral Presentation at 2009 Digestive Disease Week 3ChemoCentryx's Traficet-EN(TM) Phase II/III Induction Phase Data in Crohn's Disease to be Featured in Oral Presentation at 2009 Digestive Disease Week 4ChemoCentryx's Traficet-EN(TM) Phase II/III Induction Phase Data in Crohn's Disease to be Featured in Oral Presentation at 2009 Digestive Disease Week 5
(Date:11/23/2009)..., University of Southern California biomedical eng... develop a new tool to help clinicians distinguish...rom chronic problems manageable with drugs and lif...eters inserted into the arteries feeding the heart...umen") of these blood vessels, often revealing dep...
(Date:11/23/2009)...A novel approach to classify the gender of six-wee...icks from being killed shortly after birth, accord...ity of Technology in Germany and his team. Their u...r of young birds shows that it is a fast and accur...eeding industry to identify and select female eggs...
(Date:11/23/2009)...Sewer overflows are a nasty business, posing dange...lina State University is launching a new project w... Agency (EPA) that targets the fat and grease that...nd will give urban planners new tools to further r...overflows from "sanitary" sewer systems, as oppose...
Breaking Biology News(10 mins):Stable plaque or heart attack plaque? USC researcher builds new sensor to tell which is which 2Rescuing male turkey chicks 2Lose the fat: Targeting grease to curtail sewer overflows 2Drink Up 21 SCAN Health Plan Quenches Thirst of Area Seniors With 1 000 Cases of Bottled Water From Community Water Drive 54445 1Drink Up 21 SCAN Health Plan Quenches Thirst of Area Seniors With 1 000 Cases of Bottled Water From Community Water Drive 54445 2Mylan Pharmaceuticals Receives Final FDA Report and Reaffirms Its 48 Year Exemplary Record of Quality 54443 1Mylan Pharmaceuticals Receives Final FDA Report and Reaffirms Its 48 Year Exemplary Record of Quality 54443 2New Guidelines Provide Clarity About Probiotics 54441 1New Guidelines Provide Clarity About Probiotics 54441 2
...chers at Albert Einstein College of Medicine of Ye... brain enzyme may play a role in preventing weight... Cell Metabolism . , To understand what drives hu... have focused on the hypothalamus, an almond-sized...rols body temperature, hunger, and thirst. Specia...
...iscover a new species, it would be in some remote,...w York. But a team from the Sackler Institute for ...ural History has done the unexpected. Looking at t...rs found that the groupgenetically speakingcompris...t only ends a long debate about the taxonomy of th...
...aten to lead to the break-up of the Wilkins Ice Sh...ce shelf available to the public via the ,Webcam, ...pments as they occur. , The Wilkins Ice Shelf, a ...ntarctic Peninsula, has undergone many changes in ...late November), newly formed rifts were discovered...
Other Biology News:Brain enzyme may play key role in controlling appetite and weight gain 2Dwarf crocodiles split into three species 2
PIP Array from Echelon Biosciences Inc.
...rf Reference Series 2000 Pipette is a synonym for ... robust design, and superior operating comfort. It...e the measuring stroke and blow-out as well as eje...p" system ensures utmost accuracy and precision. E...
Goat Anti-Human STMN2 Polyclonal Antibody, Unconjugated from Abcam
Mouse Anti-Human PAEP Monoclonal Antibody, Unconjugated, Clone 6G2 from Novus Biologicals
Biology Products: