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