Accelerated Degradation Experiment
Conditions
Procedure A: |
30 days exposure at 50 °C and 100% relative humidity. |
Procedure B: |
30 days exposure at 50 °C and 100% relative humidity followed by 5 days at 70 °C and 100% relative humidity. |
Appearance of the substance
The substance, originally in the form of white, crystalline granules or a white, crystalline powder, changes after procedure B into a yellow mass.
Gain of moisture
Before exposure to heat and humidity: |
0.7% |
After procedure A: |
1.5% |
pH-value
Before exposure to heat and humidity: |
6.45 |
After procedures A and B: |
6.50 |
Specific optical rotation
Prepare a 3% solution in water.
Before exposure to heat and humidity: |
47 ° |
After procedure A: |
46 ° |
Colorimetric determinations of organic impurities
Add 2 ml of concentrated sulfuric acid to 0.5 g of each of the samples subjected to procedures A and B: a yellow to brown coloration is produced.
Add 1 ml of 0.005% of chromotrope 2B in concentrated sulfuric acid to each of the samples subjected to procedures A and B: the initial violet coloration changes to blue-green.
Conclusion
Calcium gluconate is subject to slight decomposition under accelerated degradation conditions.
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