Stability Testing, stability studies, cGMP stability testing

Stability Testing

Almac provides a complete onsite cGMP stability service, encompassing protocol design, study management and analysis.

Our state-of-the-art, walk-in rooms located in the UK and USA, provide comprehensive ICH-compliant, climatic storage facilities, including:

  • 25°C / 60% RH
  • 30°C / 65% RH
  • 30°C / 75% RH
  • 40°C / 75% RH
  • 5°C
  • -20°C
  • Photo-stability

All conditions are continually monitored, with back-up systems ensuring a totally secure and controlled environment.

Almac’s dedicated and experienced stability team are currently managing over 150 live programmes, including full ICH method development and validation. This capability enables us to conduct physical and chemical stability studies on both API and a diverse range of drug products.

We have the enviable capability of being able to combine our core stability testing services with world-class synthetic organic chemistry expertise.  This means that degradation pathways can be elucidated and the associated degradation products synthesised and characterised for susbsequent used in stability projects.

Almac Advantage

State of the Art Analytical Laboratories

With a recent investment of £9million in state-of-the-art analytical / microbiological laboratories we provide a comprehensive range of analytical solutions.

Experienced Analysts

Over 150 highly qualified, experienced analytical scientists

Integration of Analytical Scientists

We have a wide range of analytical scientists on a single site including; organic chemists, analytical development scientists and commercial quality control analysts.

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