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 4 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 pasty, light brown powder and after procedure B into a dark red-brown solution.
Gain of moisture
After procedures A and B: 33%
Chromatographic test
Adsorbent: Silica gel F-254
Solution applied to the plate: Substance dissolved in water.
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 chromatogram obtained from the solution of the sample subjected to procedure A in comparison to the chromatogram obtained from the reference solution of isoprenaline sulfate displays tailing below the main spot indicating a degradation of less than 10% After procedure B, the substance displays the same chromatographic characteristics as after procedure A. The degradation remains unchanged.
Conclusion
Isoprenaline sulfate is subject to decomposition under accelerated degradation conditions.
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