Accelerated Degradation Experiment
Conditions
Procedure A: |
30 days exposure at 50 °C and 100% relative humidity. |
Procedure B: |
30 days exposure at 50 °C and 100% relative humidity followed by 5 days at 70 °C and 100% relative humidity. |
Appearance of the substance
The substance, originally in the form of a white or almost white, crystalline powder, changes after procedure A. into a light yellow powder and after procedure B into a light brown solution containing crystals of the same colour.
Gain of moisture
After procedures A and B: 65%
Chromatographic test
Adsorbent: Silica gel F-254
Solution applied to the plate: Substance dissolved in methanol.
Solvent system:
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: The spots obtained from the solution of the sample subjected to procedure A and the spots obtained from the reference solution of isoprenaline hydrochloride display the same chromatographic characteristics of migration and detection. After procedure B, tailing is observed below the main spot indicating a degradation of 5%.
Ultraviolet and infrared spectrophotometry
After procedures A and B: |
no change in the spectra. |
Conclusion
Isoprenaline hydrochloride is subject to decomposition under accelerated . degradation conditions.
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