Stability Studies

Long-Term Stability Studies
Solvias performs long-term 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 and -80 °C). Furthermore, we can organize special storage upon request (for example, special temperatures/relative humidity or various orientations of containers).

Based on their specific needs, stability protocols outlining all details of the study are written 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 portfolio and in-house expertise. Either a full stability report or only analytical data will be provided, as mutually agreed.

Short-Term Studies
Apart from long-term studies, Solvias can also provide short-term studies such as use tests, temperature cycle tests, and others considered to be useful in the development phase of a drug.

Stress Tests and Stability-Indicating Method Development
Solvias has standard procedures for performing stress testing of samples in accordance with ICH conditions, and in agreement with the customer's specific needs. Stress testing typically includes:

• Oxidative stress
• Thermal stress
• pH stress (acidic and alkaline conditions)

During stress testing, analytical methods are checked and optimized to be stability-indicating. If necessary, we can develop customized stability-indicating methods.

Photostability Testing
Solvias is equipped to perform photostability testing according to the ICH Q1B guidelines:

• Confirmatory Study
• Forced Degradation Study