Stability studies provide evidence of how a drug substance or product varies over time under the influence of a variety of environmental factors such as temperature and humidity. Stability testing evaluates the extent to which a formulated product retains throughout its period of storage the same properties and characteristics possessed at the time of its packing.
To ensure that you meet your regulatory commitment we can provide assistance with any part of your stability program from a complete solution where we design your protocol, store and test your products and provide analysis of the results in a concise report to storage only or testing only.
We offer storage for ‘long-term’ studies (at storage conditions recommended by the product label) and ‘accelerated’ studies (designed to increase the rate of chemical degradation).
We can design protocols in accordance with current ICH guidelines, WHO guidelines or bespoke in-house requirements to ensure that the data that is generated delivers the most possible for your specific product.
- Residual solvents
- Related Substances & Impurities
- Potency / Assay
- Physical / Chemical
- Microbial Limits Test
- Efficacy of Antimicrobial Preservation (Antimicrobial Effectiveness)