Stability testing

Shelf-life studies of drug substances in commercial dosage forms are an essential element of the quality control process for manufactured pharmaceuticals.

Our high-calibre team can design and manage comprehensive stability studies and product stability protocols, with analysis at set time points that follow the ICH (International Committee on Harmonisation) guidelines.

Douglas Manufacturing has international standard stability chambers with 24 hour monitoring and alarms, and full storage facilities.

Services include:

Storage of product formulations to validated ICH standard conditions

• 5°C ± 3°C
• 25°C ± 2°C / 60% ± 5% RH (Relative Humidity)
• 30°C ± 2°C / 65% ± 5% RH
• 30°C ± 2°C / 75% ± 5% RH (Asean conditions)
• 40°C ± 2°C / 75% ± 5% RH

Short-term, long-term and accelerated aging trials

Trial formulations to well-established commercial products

Rapid troubleshooting of problems and identification of OOS (Out of Specification) root causes

Comprehensive reports, tables and trend analysis provided