Accelerated Degradation Experiment
Conditions
Procedure A: |
8 days exposure at 50 °C and 100% relative humidity. |
Procedure B: |
30 days exposure at 50 °C and 100% relative humidity. |
Procedure C: |
30 days exposure at 50 °C and dry atmosphere. |
Appearance of the substance
The substance, originally in the form of a white or yellowish white and odourless or almost odourless powder, changes after procedure A into a dark brown liquid with a strong odour. After procedure C there is no further change.
Gain of moisture
Before exposure to heat and humidity: |
2.6% |
After procedure B: |
37% |
Ultraviolet spectrophotometry
The spectrum of an aqueous solution of the sample subjected to procedure B shows a deformation of the curve with an absorption maximum at about 310 nm. After procedure C, no further change is observed
Microbiological activity
The results are expressed with reference to the dried substance.
Before exposure to heat and humidity: |
667 U/mg |
After procedure B: |
625 U/mg |
Conclusion
Neomycin sulfate is subject to decomposition under accelerated degradation conditions.
Loading...
