PREGABALIN -4-ELIMINATE, PREGABALIN 5-ELIMINATE, THEIR USE AS REFERENCE MARKER AND STANDARD, AND METHOD TO PRODUCE PREGABALIN CONTAINING LOW LEVELS THEREOF

摘要

The present invention provides 3- (aminomethyl)-5-methylhex-4-enoic acid (Pregabalin- 4-eliminate or PRG-4E) and 3- (aminomethyl)-5-methylhex-5-enoic acid (Pregabalin-5-eliminate or PRG-5E), and their uses as reference markers and standards for determining the purity of Pregabalin. The invention also provides a method to produce Pregabalin containing low levels of these impurities.