Abstract
The racemization of ketorolac was studied in aqueous buffered solution at 25 and 80°C and analyzed in detail with respect to the catalytic species in solution. The reaction has a U shaped pH rate profile at 80°C with the pH of maximum stability occurring in the region of pH 3.0—7.5. AT90value of 8 months was observed for a 1.5% (R)‐ketorolac tromethamine solution at pH 7.4 and 25°C. Additionally, the data shows that alternative salt forms are necessary in order to prepare a stable single isomer formulation. Alternative buffers, in particular phosphate buffer, provide formulations exhibiting aT90greater than 2 years.
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