(1986; 119 pages)
Accelerated Degradation Experiment
30 days exposure at 50 °C and 100% relative humidity.
30 days exposure at 50 °C and 100% relative humidity followed by 4 days at 70 °C and 100% relative humidity.
Appearance of the substance
The substance, originally in the form of colourless crystals or a white, crystalline powder, changes gradually after procedures A and B into a hard, reddish-brown mass.
Gain of moisture
After procedures A and B: 8%
Adsorbent: Silica gel F-254
Solution applied to the plate: Substance dissolved in acetone.
Solvent system: chloroform
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 in a chromatographic chamber containing some iodine crystals until spots appear.
Results: The spots obtained from the solution of the sample subjected to procedure A and the spots obtained from the reference solution of colecalciferol indicate a degradation of about 50%. Several spots less mobile than the main spot and other more mobile spots are observed. After procedure B, the number of additional spots does not increase, but some are intensified.
Colecalciferol is subject to decomposition under accelerated degradation conditions.