Abstract
The oxidative decomposition of dipyrone was studied in a preliminary way by utilizing hydrogen peroxide and molecular oxygen. During these studies, it was determined that hydrolysis of dipyrone will also occur and form at least two decomposition products: bis[N-methyl(antipyrinyl)amino]methane and N-methyl-aminoantipyrine. The structures of these two products were confirmed by studies of their TLC, melting points, and spectral characteristics compared to synthesized knowns. Stability studies conducted at pH values ranging from 4.8 to 8.8 showed that the initial rate of loss of dipyrone was very rapid regardless of the initial pH of the solution. Within the range of values examined, the dipyrone solutions showed the least decomposition at pH values above 7.8. These preliminary studies suggest that dipyrone should show optimum stability if stored completely anhydrous and excluded from the atmosphere. In liquid dosage forms, improved stability should be obtained by flushing the head-space with an inert atmosphere and by incorporating a suitable antioxidant.
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