Stability

Stability testing generates evidence on the quality of APIs and products over time. It is possible to determine shelf life and storage conditions for the product by stressing it under a combination of light, temperature and humidity.

Product Degradation

This data is a key part of submissions to regulatory bodies and the stress testing of drug substances. This helps identify degradation products, their pathways and ultimately product safety.

Development & Validation

Stability Storage Conditions BCM can offer

During development and validation of analytical methods, BCM perform stress studies. This is to help predict how a product formulation may perform under harsh storage conditions. We optimise our methods to ensure a number of items, for example, any impacts on the formulation during the stability study are detected. We store products in ICH Climatic Zones I to IV, providing us with confidence in our data when testing samples.

25°C/60% RH
30°C/65% RH
30°C/75% RH
40°C/75% RH
5°C
Light

Pharmaceutical Stability Studies

We offer an assortment of studies that may be considered important to your product submission, for instance, transit excursion studies and in use studies. We have a team of experts who will be on hand to help design your stability study and assure its delivery.

Stability Studies

Our services include full pivotal and in-use testing for multi-dose products for new licence applications under ICH guidelines.

More info

Storage

Our Nottingham site offers storage in a range of walk-in stability cabinets at a variety of conditions. We are able to support all ICH conditions, as well as a range of bespoke and cosmetic conditions, and storage of aerosols in our ICH cabinets.

More info