Process for the preparation of an isotonic aqueous ropivacaine injection.

摘要

Process for the preparation of a solution of ropivacaine base in an aqueous medium comprising: (1) providing ropivacaine base or a suspension of ropivacaine base in an aqueous medium; (2) mixing said ropivacaine base or suspension with hydrochloric acid wherein the acid is present in an amount effective to dissolve said ropivacaine extramolar amount; and (3) adjusting the pH of the solution with sodium hydroxide to a range of about 3.9 to about 6.5.