Accelerated Degradation Experiment
Conditions
Procedure A: |
30 days exposure at 50 °C and 100% relative humidity. |
Procedure B: |
30 days exposure at 50 °C in a dry atmosphere. |
Appearance of the substance
The substance, originally in the form of a white or almost white, crystalline powder, changes after procedure A into yellowish agglomerates. After procedure B the appearance of the substance remains unchanged.
Gain of moisture
Before exposure to heat and humidity: |
4.7% |
After procedure A: |
5.3% |
After procedure B: |
4.7% |
Solubility and colour of solution
Dissolve 0.1 g of the substance in 10 ml of water. |
| |
|
Before exposure to heat and humidity: |
colourless |
After procedure A: |
yellow |
After procedure B: |
colourless |
Melting point
Before exposure to heat and humidity: |
119 °C |
After procedure A: |
117.7 °C |
After procedure B: |
119 °C |
Iodometric determination
Before exposure to heat and humidity: |
1030 U/mg |
After procedure A: |
994 U/mg |
After procedure B: |
1008 U/mg |
Microbiological activity (turbidimetric method)
Before exposure to heat and humidity: |
1065 U/mg |
After procedure A: |
1005 U/mg |
After procedure B: |
1055 U/mg |
Ultraviolet and infrared spectrophotometry
No changes are observed in the spectra.
Conclusion
Procaine benzylpenicillin is slightly decomposed under accelerated degradation conditions.
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