Abstract
The degradation of the superagonist LH-RH analog nafarelin acetate (I) in aqueous solution was followed by reverse-phase HPLC. The log k obsvs pH profile for I at 80°C displayed a U-shaped profile with a pH region of maximum stability between pH 4 and 6. In the acid pH region, specific acid-catalyzed hydrolysis of the glycinamide group occurs to give the free acid of I as a major degradation product. HPLC chromatograms indicate that numerous products, including a small amount of free acid, are formed in the region from pH 4 to 10. Degradation at lower temperatures indicate the pH of maximum stability was pH ~ 5.3 at 40°C with a predicted T 90 of 3.8 years at 25°C.
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