Stabilities according to international guidelines

Stability studies play a fundamental role in the development and approval of new products and active pharmaceutical ingredients. We offer consultancy services and customized support to our clients during all phases of a study from the planning process and organization to the study implementation including analysis and data reporting.

Stability studies of Nordmark active pharmaceutical ingredients and drugs

Nordmark conducts stability studies on the active pharmaceutical ingredients and drugs it manufactures based on the following international regulations:

  • ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)
  • EMA (European Medicines Agency)
  • WHO (World Health Organization)

This allows us to cover the following climate conditions, which are valid and/or accepted worldwide:

WHO Climatic Zones for long-term stability studies

WHO Climate zoneClimateTemperature / 
relative humidity
Suitability
ITemperate Climate21°C (70°F)/45%Long-term stability
studies
IISubtropical and Mediterranean
climate
25°C (77°F)/60%Long-term stability
studies
IVAHot and humid climate30°C (86°F)/65%Long-term stability
studies
IVBHot and very humid climate30°C (86°F)/75%Long-term stability
studies

 

 

Additional climate conditions for storage precautions

Temperature / Relative humiditySuitability
30°C (86°F)/65 % Intermediate stability studies
40°C (104°F)/75 %Accelerated stability studies
2 - 8°C (36 - 46°F)Designated storage in a refrigerator, i.e. according to the European Pharmacopoeia’s "keep in a cool place"
 - 20°C (-4°F)For intended storage in a freezer, 

"to be kept frozen" according to the European Pharmacopoeia 


Stability studies conducted by Nordmark also include those on stability after the container/package has been opened (stability after opening) and stability testing of active pharmaceutical ingredients and drugs under irradiation with strong, simulated daylight (photostability). In addition, Nordmark is authorized to carry out stability tests on narcotics.

The analytical results data of the stability test is evaluated both by visual means/tables and graphical representations, using the most advanced mathematical and statistical methods. For this purpose, we use the software tool STATISTICA.