Process for the preparation of isotonic aqueous injection of ropivacaine

摘要

The preparation of an injectable solution of ropivacaine by dissolving ropivacaine base in aqueous acidic solution having a molar ratio of acid to ropivacaine base greater than 1:1 eliminates the need for a hydrochloride or hydrochloride monohydrate intermediate in the manufacture of the injectable. The osmolality can be adjusted as needed. The excess acid is neutralized with a base.