Accelerated Degradation Experiment
Conditions
Procedure A1: |
10 days exposure at 50 °C and 100% relative humidity. |
Procedure A2: |
30 days exposure at 50 °C and 100% relative humidity. |
Procedure B: |
30 days exposure at 50 °C and 100% relative humidity followed by 7 days at 70 °C and 100% relative humidity. |
Appearance of the substance
The substance, originally in the form of a white or almost white powder remains unchanged after procedure A2, but changes to a rose-orange coloured liquid after procedure B.
Gain of moisture
Before exposure to heat and humidity: |
0.5% |
After procedure A2: |
2% |
After procedure B: |
80% |
Chromatographic test
Adsorbent: Silica gel F-254
Solution applied to the plate: Substance dissolved in methanol.
Solvent system:
concentrated ammonia .......... 4 volumes
water .................................... 16 volumes
2-propanol ........................... 30 volumes
ethyl acetate ......................... 50 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 spots obtained from the solutions of each of the samples subjected to procedures A1 and A2, and the spot obtained from the reference solution of salbutamol sulfate display the same chromatographic characteristics of migration and detection. No secondary spots are revealed. After procedure B, five additional spots are detected.
Conclusion
Salbutamol sulfate is subject to decomposition only at higher temperatures as seen after procedure B.
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