Cookies on the
LGC website
We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we’ll assume that you are happy to receive all cookies on the LGC website. However, if you would like to, you can change your cookie settings at anytime.
Question markFind out more

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.