Accelerated Degradation Experiment
Conditions
Procedure A1: |
10 days exposure at 50 °C and 100% relative humidity. |
Procedure A2: |
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 a white, crystalline powder changes after procedure A1 into a yellow liquid.
Gain of moisture
Chromatographic test
Adsorbent: Aluminium oxide F-254
Solution applied to the plate: Substance dissolved in ethane 95%.
Solvent system:
methanol .......................... 100 volumes
concentrated ammonia ..........3 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 A1 and the spots obtained from the reference solution of hyoscyamine sulfate display the same chromatographic characteristics of migration and detection.
Ultraviolet spectrophotometry and colorimetric determination
After procedure A1, the UV measurement and the colorimetric determination after formation of a picrate at 400 nm, indicate a degradation of slightly larger than 10%
Conclusion
Hyoscyamine sulfate is subject to decomposition under accelerated degradation conditions.
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