Stability Studies

Formurex maintains standard environmental chambers in compliance with ICH storage conditions, including 25°C/60% RH, 30°C/65% RH, 40°C/75% RH, -20°C, and 5°C. All chambers are continuously monitored 24/7 and supported by a backup power generator to ensure uninterrupted operation.

• Draft/review/approve stability protocols.
• Prepare and update stability reports.
• Monitor stability through trend charts with expert input on statistical analysis.
• Update and consult with sponsors on the analysis of stability trends.
• Ensure expiry dates on lots of DS and DP intended for clinical use are updated on a timely basis with appropriate amendments to certificates of analysis (COA).
• Communicate expiry date changes to stakeholders.
• Prepare stability tables and charts for regulatory submissions as directed by the client.