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Synthesis of potential impurities of cloxacillin sodium drug substance
Authors:Gollapalli Venkateswara Rao  Santhosh R. Pindi  Bollikolla Hari Babu  Bala Murali Krishna Khandapu
Affiliation:1. Chemical Research Department, APL Research Centre-II, Aurobindo Pharma Ltd., Sangareddy, India;2. Department of Chemistry, Acharya Nagarjuna University, Guntur, India
Abstract:The present work describes the synthesis and characterization of six related compounds of cloxacillin sodium ( 1 ) viz penicilloic acid of cloxacillin (2) , (3-(2-chlorophenyl)-5-methylisoxazole-4-carbonyl) glycine (Glycine analogue of cloxacillin) (3), CMICAA adduct of cloxacillin (4) , (4S)-2-(carboxy(3-(2-chlorophenyl)-5-methylisoxazole-4-carboxamido) methyl)-3-(2-ethylhexanoyl)-5,5-dimethylthiazolidine-4-carboxylic acid (N-2-ethylhexanoyl penicilloic acid of cloxacillin) ( 5 ), N-Acetylated penicilloic acid of cloxacillin ( 6 ), and Cloxacillin Penicillamide (7) . These related compounds are very essential in the process development of cloxacillin sodium and are used as reference standards to determine the quality of the drug substance.
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