Effect of Autoxidation of Hydrogenated Castor Oil Containing 60 Oxyethylene Groups on Degradation of Miconazole.

N‐Methylation and N‐Formylation of a Secondary Amine Drug (Varenicline) in an Osmotic Tablet

“…Cores were compressed with the individual components of the CR coating and subjected to an abbreviated accelerated (high temperature, high humidity) condition PEG is known to undergo oxidative degradation to generate (among other things), formic acid and formaldehyde. [8][9][10][11][12] Although the exact mechanism of the formation of these two products is not entirely established, Scheme 1 shows a reasonable autoxidation pathway. 12 Formaldehyde and formic acid (formate), can in theory, react with an amine drug.…”

Reactive Impurities in Excipients: Profiling, Identification and Mitigation of Drug–Excipient Incompatibility

“…The degradation of the active was accelerated by the formic acid in the formulation. In yet another study, nonspecific degradation of miconazole, which is a tertiary amine compound and commonly used as an antifungal agent, was observed in a liquid formulation of hydrogenated castor oil and lactic acid (57). The hydrogen peroxide, formaldehyde, and formic acid from the hydrogenated castor oil on stability were identified as the cause of this instability.…”