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 a white or almost white, crystalline powder, changes after procedure A into a grey mass.
Gain of moisture
After procedure A: 34%
Chromatographic test
Adsorbent: Aluminium oxide F-254
Solution applied to the plate: Substance dissolved in ethane 95%.
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 fluphenazine hydrochloride display the same chromatographic characteristics of migration, but the intensity of the spots of the sample subjected to the test diminish.
Ultraviolet spectrophotometry and colorimetric determination
After procedure A, the UV measurement at 260 nm and the colorimetric determination after formation of a picrate at 400 nm , indicate a degradation of about 10%.
Conclusion
Fluphenazine hydrochloride is subject to decomposition under accelerated degradation conditions.
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