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 ± 5 °C |
n.a. |
Product storage in freezer |
| 5 ± 3 °C |
n.a. |
Product storage in refrigerator |
| 25 ± 2 °C |
60 ± 5 %RH |
Zone I and II |
| 30 ± 2 °C |
75 ± 5 %RH |
Zone IV |
| 40 ± 2 °C |
75 ± 5 %RH |
Accelerated studies |
| 50 ± 2 °C |
75 ± 5 %RH |
Stress / transportation studies |
| Further requirements as per customer request |
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