5-CHLORO-4-HYDROXY-1-METHYL-2-OXO-N-PHENYL-1,2-DIHYDROQUINOLINE-3-CARBOXAMIDE, SALTS THEREOF AND USES THEREOF

摘要

PROBLEM TO BE SOLVED: To provide laquinimod preparations and methods of producing the same that minimize the amount of DELAQ (des-ethyl-laquinimod; 5-chloro-4-hydroxy-1-methyl-2-oxo-N-phenyl-1,2-dihydroquinoline-3-carboxamide), which is an undesirable synthetic by-product of laquinimod synthesis used in treatment of multiple sclerosis (MS).SOLUTION: A production method comprises: determining by an apparatus the total amount of DELAQ in a sample of a laquinimod batch; and validating the batch for distribution if the sample of the batch is determined to contain DELAQ of less than 0.1 wt.% relative to the combined weight of laquinimod and DELAQ. Also provided is a pharmaceutical composition using the batch.SELECTED DRAWING: None