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 or almost white, crystalline powder, changes after procedures A and B into a viscous orange coloured liquid.
Gain of moisture
After procedures A and B: 38%
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 secondary spots obtained from the solution of the sample subjected to procedure A are more numerous and intense than the corresponding spots obtained from the reference solution of benzylpenicillin potassium. After procedure B, the spots are intensified.
Conclusion
Benzylpenicillin potassium is subject to decomposition under accelerated degradation conditions.
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