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 2 days at 70 °C and 100% relative humidity. |
Procedure C: |
3 days exposure at 100 °C in a dry atmosphere. |
Appearance of the substance
The substance, originally in the form of a white to yellowish, crystalline powder, changes after procedure A1 into a greenish liquid. No change is observed after procedure C.
Gain of moisture
After procedure A1: |
20% |
After procedure A2: |
27% |
After procedure B: |
30% |
Chromatographic test
Adsorbent: Silica gel F-254
Solution applied to the plate: Substance dissolved in methanol.
Solvent system:
methanol ................. 1 volume
acetone ................... 1 volume
triethanolamine ....... 0.03 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 sprayed with iodoplatinate reagent (a mixture of 5 ml of a 5% solution of hexachloroplatinate in 1 N hydrochloric acid, with 45 ml of a 10% solution of potassium iodide, and 100 ml of water).
Results: The spots obtained from the solutions of each of the samples subjected to procedures A1, A2, B and C, and the spots obtained from the reference solution of promazine hydrochloride display the same chromatographic characteristics of migration and detection.
Ultraviolet spectrophotometry
The absorbance is measured at about 310 nm using a 0.0005% solution of the samples subjected to the test in 0.01 N hydrochloric acid.
After procedure A2: |
68%. Taking the content of moisture of 27% into consideration, it represents a degradation of slightly less than 10%. |
After procedure C: |
no degradation is observed. |
Conclusion
Promazine hydrochloride is subject to decomposition after procedures A and B.
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