Accelerated Degradation Experiment
Conditions
Procedure A1: |
8 hours exposure at 50 °C and 100% relative humidity. |
Procedure A2: |
24 hours exposure at 50 °C and 100% relative humidity. |
Procedure A3: |
2 1/2 days exposure at 50 °C and 100% relative humidity. |
Procedure B: |
30 days exposure at 50 °C and 100% relative humidity. |
Appearance of the substance
The substance, originally in the form of a white or almost white powder, changes after procedure A1 into a hard and sticky yellow mass, after procedure A2 into a yellow-orange gel, after procedures A3 and B into a yellow-orange liquid.
Gain of moisture
Before exposure to heat and humidity: |
4.6% |
After procedure B: |
9.3% |
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 examined under ultraviolet light at a wavelength of maximum output at about 254 nm, and then 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 B are more numerous than the corresponding spots obtained from the reference solution of carbenicillin sodium.
Acidimetric titration
After procedure A2: |
50% degraded |
After procedure B: |
100% degraded |
Iodometric titration
After procedure A1: |
30% degraded |
After procedure A2: |
70% degraded |
After procedure A3: |
90% degraded |
After procedure B: |
93% degraded |
Conclusion
Carbenicillin sodium is subject to decomposition under accelerated degradation conditions.
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