Accelerated Degradation Experiment
Conditions
Procedure A1: |
20 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 yellowish white powder, changes after procedures A2 and B into small humid agglomerates.
Gain of moisture
Before exposure to heat and humidity: |
6% |
After procedures A2 and B: |
30% |
Chromatographic test
Adsorbent: Silica gel F-254
Solution applied to the plate: Substance dissolved in methanol.
Solvent system:
chloroform ................ 9 volumes
acetone ...................... 1 volume
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: After procedure A1 a secondary spot is observed that is more mobile than the main spot. After procedure B the secondary spots are intensified.
Conclusion
Thiopental sodium is subject to decomposition under accelerated degradation conditions.
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