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 3 days at 70 °C and 100% relative humidity. |
Appearance of the substance
The substance, originally in the form of a white or faintly yellow, crystalline powder, changes after procedure A into a greyish anthracite coloured powder and after procedure B into a black powder.
Gain of moisture
After procedure A: 11%
Chromatographic test
Adsorbent: Silica gel F-254
Solution applied to the plate: Substance dissolved in a mixture of methanol and water (8:2).
Solvent system:
2-propanol: ...........................4 volumes
acetone: ................................2 volumes
concentrated ammonia: ........4 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 examined under ultraviolet light at a wavelength of maximum output at about 254 nm and 365 nm, and then 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 ergometrine hydrogen maleate display the same chromatographic characteristics of migration and detection. After procedure B, two additional spots are obtained and some tailing.
Conclusion
Ergometrine hydrogen maleate is subject to decomposition under accelerated degradation conditions.
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