Long-Term Stability Studies
We have a track record in delivering long-term pharmaceutical stability testing and stability studies according to ICH guidelines for drug development. We can also take on follow-up stability studies for all ICH standard storage conditions and low temperature storage (-20°C).
If you have a special storage request (for example, special temperatures/relative humidity or various orientations of containers), let us know. When it comes to meeting individual customer needs, no request is too big for us.
Before beginning a stability study, pharmaceutical stability testing protocols outlining all details of the study are written by us and approved by you. We have the know-how, analytical equipment and experience to deal with unexpected situations during the stability study, such as the appearance of new degradation products. Either a full stability report or only analytical data can be provided, as mutually agreed.
Short-Term Stability Studies
We can carry out short-term pharmaceutical stability testing studies, always with your needs in mind.
Stress tests and stability-indicating method development forced degradation studies are performed to aid in the development of stability indicating methods and give an idea of compound stability. Using our established forced degradation standard operating procedure (SOP), we can provide you with valuable stability testing data which helps in early phase container and closure system design. The typical stress tests performed include:
- pH stress (acidic and basic conditions)
- Oxidative stress testing
- Thermal stress testing
- Photostability stress testing
During stress testing, analytical methods are checked and optimised to be stability-indicating. If you need them, we can develop customised stability-indicating methods.
Pharmaceutical stability testing of an API is a necessary requirement during lead optimisation and following selection of a clinical candidate. In conjunction with our solid state service and analytical laboratory we offer a full range of tests according to the ICH harmonised tripartite guidelines. Our stability offering encompasses both solid and solution forms for testing across a range of conditions, We use state of the art stability and photocabinets as standard. Only the best for our clients.
Both intermediate and long term assessment is available, alongside accelerated studies as indicated below:
Indication of stability study parameters
|Long term||25 °C ± 2 °C/60% RH ± 5% RH
30 °C ± 2 °C/65% RH ± 5% RH
|Intermediate||30 °C ± 2 °C/65% RH ± 5% RH||6 months|
|Accelerated||40 °C ± 2 °C/75% RH ± 5% RH||6 months|
Forced degradation studies are also available for both solids and solutions whereby compounds are exposed to various stress factors such as oxidative (peroxide), pH range, photostability (min. 1.2 million Lux hours) as well as varying relative humidity and temperature ranges. Purity assessments are measured at appropriate intervals by high performance liquid chromatography (HPLC) using a validated, impurity indicating method.
Impurity identification and isolation is also an offering available from analytical services that complements the stability studies above.
As part of our wider chemical offering, we can provide you with a range of proprietary chemical products. Please check out our product catalogue using the link below and get in touch if you would like to order or know more about any of our products and services.