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 very slightly yellow, crystalline powder, changes after procedure A into a creamy white powder.
Gain of moisture
After procedure A: 2.4%
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:
cyclohexane: ..........................10 volumes
acetone: ..................................20 volumes
toluene ....................................20 volumes
concentrated ammonia: .............1 volume
The solvent is mixed, decanted and after separation of the aqueous layer, the organic layer is used for the test.
Results: A series of spots are obtained from the solution of the sample subjected to procedure A compared to the spot obtained from the reference solution of emetine hydrochloride.
High performance liquid chromatography
After procedure A: 13% degraded
Ultraviolet spectrophotometry
The spectrum of a 0.1% solution of the sample subjected to procedure A in methanol confirms degradation.
Conclusion
Emetine hydrochloride is subject to decomposition under accelerated degradation conditions.
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