Composiciones farmacéuticas de clevidipina y métodos para producir concentraciones de baja impureza de las mismas

摘要

A pharmaceutical composition is provided which comprises clevidipine as an active ingredient and has a level of the degradants Substance 23, Substance 24 and Substance 25 that is approximately equal to or no more than 0.2% on a weight-by-weight of impurity basis to clevidipine and an amount of the impurity H168/79 that is no greater than about 1.5%.