ICH stability studies


Long-term stability under controlled storage conditions

Stability testing, which is performed in suitable climate chambers at controlled temperature and relative humidity (r.h.) can be offered as part of formulation development projects, supply of pre-clinical material or as independent service package.

Standard storage conditions available at Coriolis Pharma are:

frozen storage
-156 °C, -80 °C, -40 °C, -30 °C and -20 °C

storage according to ICH guidelines for liquid and lyophilized products
(e.g., 2-8 °C, 25 °C/60% r.h., 30 °C, 40 °C/75% r.h.).

Virtually all other temperature and relative humidity conditions can be offered as well, e.g., for kinetic studies.

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