Pharmaceutical batch(es) or pharmaceutical formulation(s) comprising
bivalirudin as the active ingredient, and a method of preparing the
pharmaceutical batch(es) or pharmaceutical formulation(s). The
pharmaceutical batch(es) or pharmaceutical formulation(s) may have a
maximum impurity level of Asp.sup.9-bivalirudin that does not exceed
about 0.6%. Also, the pharmaceutical batch(es) or pharmaceutical
formulation(s) may have a reconstitution time that does not exceed about
42 seconds. The method of preparing the pharmaceutical batch(es) or
pharmaceutical formulation(s) may comprise dissolving bivalirudin in a
solvent to form a first solution, efficiently mixing a pH-adjusting
solution with the first solution to form a second solution in which the
pH-adjusting solution may comprise a pH-adjusting solution solvent, and
removing the solvent and the pH-adjusting solution solvent from the
second solution.