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, crystalline powder separates after procedures A and B into two phases, white crystals in a red-brown coloured liquid.
Gain of moisture
After procedures A and B: 10%
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 spots obtained from the solutions of each of the samples subjected to procedures A and B and the spot obtained from the reference solution of chlorphenamine hydrogen maleate display the same chromatographic characteristics of migration and detection. The same characteristics are observed from the spot corresponding to maleic acid.
Conclusion
No decomposition is detected by thin-layer chromatography. but the appearance of the substance changes after procedures A and B.
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