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 7 days at 70 °C and 100% relative humidity. |
Appearance of the substance
The substance, originally in the form of fine, white crystals, changes after procedure A into an amber-coloured liquid.
Gain of moisture
Chromatographic test
Adsorbent: Silica gel F-254
Solution applied to the plate: Substance dissolved in 0.01 N sulfuric acid.
Solvent system:
methanol ........................... 100 volumes
concentrated ammonia ...... 1.5 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 orciprenaline sulfate display the same chromatographic characteristics of migration and detection. No additional spots are obtained.
Ultraviolet spectrophotometry and colorimetric determination
After procedure A, the UV absorbance at 276 nm and the colorimetric determination through the reaction with chloranil, indicate a degradation of about 35%.
Conclusion
Orciprenaline sulfate is subject to decomposition under accelerated degradation conditions.
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