The stability of drugs and other products are important when their storage life has to be decided. DB Lab offers stability testing at many different conditions as well as light sensitivity tests under controlled conditions

In order to obtain approval of pharmaceuticals and herbal medical products, the Danish Medical Agency demands documentation regarding stability. The stability studies are made in accordance with ICH guidelines.

DB Lab has climate chambers for storage at standard conditions (25°C, 60% RH) and accelerated conditions
(30°C, 65% RH or 40°C, 75% RH). Other conditions can be arranged.

In addition, we have a photostability chamber for testing the influence of light on pharmaceuticals and herbal medical products under monitored temperature and humidity conditions.

DB Lab offers to monitor the stability studies, to take out samples, and to carry out tests according to a pre-arranged plan.

DB Lab has climate chambers with UV- and VIS light. Products can be exposed for a certain known amount of light of a certain wavelength at constant temperature and humidity conditions. The light intensity is continuous measured with a traceable calibrated light meter.

DB Lab has

• Climate chambers
• Climate chambers for photostability testing

TYPICAL CONDITIONS

25°C±2°C / 60%±5% R.H.
25°C±2°C / 40%±5% R.H.
30°C±2°C / 65%±5% R.H.
30°C±2°C / 75%±5% R.H.
40°C±2°C / 75%±5% R.H.
40°C±2°C / <25% R.H.

   5°C±3°C
-20°C±5°C
-80°C±5°C

Other conditions are possible