STABILITY STUDIES


According to ICH, EMA, FDA, and WHO guidelines, stability studies are mandatory for new drug substances and products to demonstrate stability and quality of the product. ABX offers a wide range of stability monitoring studies tailored to your specific project. These include long-term and ongoing stability studies as well as accelerated or intermediate stability studies according to ICH Q1A. Moreover, we offer short-term temperature fluctuation studies or forced degradation studies applying customized and product specific validations of analytical procedures according to ICH Q2.


STABILITY EQUIPMENT

Modern stability chambers and cabinets are available for following conditions with climatic zones I-IV.

Zone Type of Climate
Zone I Temperate zone
Zone II Mediterranean / subtropical zone
Zone III Hot dry zone
Zone IVa Hot humid / tropical zone
Zone IVb ASEAN testing conditions hot / higher humidity


We cover stability studies for all zones and product storages, which are:

Temperature Relative humidity Applies for
–20 °C ± 5 °C n.a. Product storage in freezer
5 °C ± 3 °C n.a. Product storage in refrigerator
25 °C ± 2 °C 60 ± 5 %RH Zone I, II, and III
30 °C ± 2 °C 75 ± 5 %RH Zone IV
40 °C ± 2 °C 75 ± 5 %RH Accelerated studies
50 °C ± 2 °C 75 ± 5 %RH Stress / transportation studies
Further requirements as per customer request