Intertek (www.intertek.com)
 

Stability Testing for Pharmaceuticals

Industries serviced: Medical & Pharmaceutical

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USA:+1-908-534-4445 x669
EMEA UK:+44 161 721 5247

Intertek QTI

P.O. Box 470
291 Route 22 East
Salem Industrial Park
Whitehouse, NJ 08888
USA

Intertek ASG

P.O. Box 42
Hexagon Tower
Blackley
Manchester, M9 8ZS
United Kingdom

Stability testing and analysis for the pharmaceutical industry.

Intertek laboratories provide stability evaluation, testing and analysis for a wide range of products, and specializes in method performance (development, validation and transfer) and the managing of large cGMP-compliant, registration stability programs for both small and large molecules.

On-site storage stability facilities are located at Intertek QTI in the USA and Intertek ASG in the UK, with walk-in chambers for all ICH conditions and reach-in chambers for specialized conditions. All chambers are continuously monitored by automated monitoring systems with full back-up power and back-up water supplies. Stability and storage programs include long-term stability, accelerated stability and comparative stability in addition to forced degradation studies.

Stability Testing Storage Conditions: 

  • 25ºC/60% Relative Humidity (RH)
  • 30ºC/60% RH, 30ºC/65% RH and 30ºC/70% RH
  • 40ºC/75% RH
  • 50ºC/75% RH
  • 2-8ºC, -20ºC, -40ºC and -80ºC storage capacity
  • Photostability (ICH Options 1 and 2)
  • Customized conditions
Stability testing evaluations for drug substance and drug product are essential components of pharmaceutical development. Stability testing provides data on how the quality of a compound varies over time under the influence of different environmental factors such as temperature, humidity and light. This in turn enables recommended storage conditions, re-testing intervals and shelf lives to be established. Comprehensive testing capabilities also include dissolution, Karl Fischer, hardness, disintegration, friability and characterization of impurities and degradants.

to see how Intertek can help your organization with Stability Testing for Pharmaceuticals.

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