Patent ID: 8716521

Claim:
A method of preparing a stable lyophilized formulation consisting essentially of canfosfamide hydrochloride and sodium citrate, wherein the said formulation is stable for therapeutic utility for at least 18 months at 5° C. and has a pH of 4.6±0.2 when reconstituted with water, which method comprises: (a) preparing a sodium citrate buffer of a pH of 6.5±0.1; (b) dissolving canfosfamide hydrochloride in the sodium citrate buffer of step (a) to provide a solution; (c) adjusting the pH of the solution of step (b) when pH is >4.8 to provide a resulting solution of pH of 4.6±0.2 by addition of a compatible acid; and (d) lyophilizing the resulting solution of step (c) to provide the said formulation.