Intertek (www.intertek.com)
 

Stability and Pharmaceutical Testing

Industries serviced: Medical & Pharmaceutical

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

Intertek ASG

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

Intertek QTI

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

Intertek offers extensive capabilities in stability analysis for the pharmaceutical industry 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.

Stability 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.

Intertek provides on-site storage facilities in the USA and 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 Conditions 

  • 25ºC/60% RH
  • 30ºC/60% RH, 30ºC/65% RH and 30ºC/70% RH
  • 40ºC/75% RH
  • 50ºC/75% RH
  • 2-8ºC, -20ºC, -40ºC and -80ºC
  • Photostability (ICH Options 1 and 2)
  • Customized conditions
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 and Pharmaceutical Testing.

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