Stability studies

are performed for active pharmaceuticals and finished dosage forms.

Our service includes consulting and planning of your stability studies as well as all necessary testing and quality assessments. We store your samples at the desired storage conditions (e.g. ICH conditions and special conditions) and take over the complete management of samples, including the analysis of the stability samples at the agreed time.

Each chamber operates independently with its own temperature and humidity controls. All storage chambers are continuously monitored by CFR 21 Part 11 compliant software.

ICH storage conditions include:

    • Long-Term:      25°C/60% RH
    • Intermediate:   30°C/65% RH
    • Accelerated:     40°C/75% RH
    • 2°C – 8°C
    • -20°C
    • ICH photo-stability

Our storage features include:

    • Chambers with temperature settings to meet your needs, ranging from Room Temperature to 40°C
    • A variety of humidity settings
    • All storage conditions fully validated and monitored 24 hours 07 days
    • An Annual Master Plan for calibration and maintenance program for all chambers and equipment, including thermocouples and data loggers
    • Interim reports for every testing time point