Accelerated Degradation Experiment
Condition
Procedure A: 30 days exposure at 50 °C and 100% relative humidity
Appearance of the substance
The substance, originally in the form of a white or pale brownish yellow and odourless powder, changes after procedure A into a yellow-orange mass with a strong and disagreeable odour.
Gain of moisture
Before exposure to heat and humidity: |
4% |
After procedure A: |
46% |
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 to dry in air and examined under ultraviolet light at a wavelength of maximum output at about 254 nm, then sprayed with triketohydrindene hydrate 0.25% and heated at 100 °C until spots appear.
Results: The spots obtained from the solution of the sample subjected to procedure A do not show the same chromatographic characteristics of migration and detection as the spots obtained from a reference solution of bacitracin.
Conclusion
Bacitracin is subject to decomposition under accelerated degradation conditions.
Loading...
