Accelerated Degradation Experiment
20 days exposure at 50 °C and 100% relative humidity.
30 days exposure at 50 °C and 100% relative humidity.
30 days exposure at 50 °C and 100% relative humidity followed by 7 days at 70 °C and 100% relative humidity.
Appearance of the substance
The substance, originally in the form of a white, crystalline powder, changes after procedure A1 into a dark brown liquid.
Gain of moisture
Adsorbent: Silica gel F-254
Solution applied to the plate: Substance dissolved in methanol.
n-butanol .............. 6 volumes
acetic acid ............ 2 volumes
water .................... 2 volumes
Development conditions: The solvent is allowed to migrate until the front reaches a line 15 cm from the starting line.
Detection: The plate is left in a chromatographic chamber containing some iodine crystals until spots appear.
Results: After procedure Al, the intensity of the main spots decreases slightly by comparison with the spots obtained from the reference solution of phentolamine mesilate. An additional less mobile spot is also observed.
The absorbance of a solution of the sample subjected to procedure A1 indicates a degradation of 17.5%.
Phentolamine mesilate is subject to decomposition under accelerated degradation conditions.