Long-Term Stability Studies
Onyx Scientific performs long-term pharmaceutical stability testing and stability studies according to ICH guidelines for drug development, and follow-up stability studies for all ICH standard storage conditions and low temperature storage (-20°C). In addition to these standard conditions, we can organise special storage upon request (for example, special temperatures/relative humidity or various orientations of containers).
Based on specific needs, pharmaceutical stability testing protocols outlining all details of the study are written by us and approved by our customers prior to beginning a stability study. We have the know-how and experience to deal with unexpected situations during the stability study, such as the appearance of new degradation products, using our complete analytical equipment base and in-house expertise. Either a full stability report or only analytical data can be provided, as mutually agreed.
Short-Term Stability Studies
In addition to long-term storage, we can carry out short-term pharmaceutical stability testing studies as agreed with the customer.
Stress Tests and Stability-Indicating Method Development Forced degradation studies are performed to aid in the method development of stability indicating methods and give an idea of compound stability. Using our established forced degradation SOP, Onyx Scientific can provide the customer with valuable stability testing data which helps in early phase container and closure system design. The typical stress tests performed consist of the following:
- 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 necessary, 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 Onyx offers 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 using state of the art stability and photocabinets.
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|
In addition to the above, forced degradation studies are 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 HPLC using a validated, impurity indicating method.
Note that impurity identification and isolation is a service offering available from analytical services that compliments the stability studies above.