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Stability testing

Stabilty testing at LGC

Stability testing, storage and programme management

Stability testing provides essential data on how the quality of a pharmaceutical product varies over time under the influence of different environmental factors such as temperature, humidity and photostability. The data generated during stability testing helps to establish either a retest period for a drug substance, or a shelf life and recommended storage conditions for a product.

cGMP stability storage

LGC has on-site cGMP stability storage at ICH conditions. We will manage your stability programmes and meet all of your analytical needs for long term assessment of API and drug products, including:
  • Protocol design
  • Accelerated and long-term stability testing
  • Drug substance stability testing
  • Finished drug product stability testing
  • Comparator testing and bioequivalence studies
  • Photostability (ICH Q1B)
  • Temperature cycling studies
We have comprehensive compendial testing capabilities for a variety of dosage forms to assess your API or drug product, and assign a shelf life (re-test period), including:
  • Solid oral dose
  • Inhaled and nasal
  • Parenteral
  • Topical/creams

For further information on our stability services, please download a copy of our fact sheet or do not hesitate to contact us.