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 8 days at 70 °C and 100% relative humidity. |
Appearance of the substance
The substance, originally in the form of a white or slightly creamy white, crystalline powder, changes after procedures A and B into a viscous dark red-brown liquid.
Gain of moisture
After procedures A and B: 50%
Chromatographic test
Adsorbent: Silica gel F-254
Solution applied to the plate: Substance dissolved in water.
Solvent system:
ammonia: ............................5 volumes
toluene: .............................60 volumes
dioxan: ..............................35 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 reference substance of chlorpromazine hydrochloride reveals several secondary spots indicating small amounts of impurities. The spots obtained from the solutions of each of the samples subjected to procedures A and B and the spots obtained from the reference solution of chlorpromazine hydrochloride display the same chromatographic characteristics of migration and detection. The secondary spots remain unchanged, no more numerous nor intense. By comparison with a reference concentration series, the degradation was assessed at about 1%.
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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