title: Identification, Isolation, and Characterization of a New Degradation Impurity in Nafcillin Sodium.
abstract: A new degradant of Nafcillin Sodium was found at a level of 1.8% w/w during the gradient reversed-phase HPLC analysis in stability storage samples. This impurity was identified by LC-MS and was characterized by (1)H-NMR, (13)C-NMR, LC/MS/MS, elemental analysis, and IR techniques. Based on the structural elucidation data, this impurity was named as N-[(2S)-2-carboxy-2-{[(2-ethoxynaphthalen-1-yl)carbonyl]amino}ethylidene]-3-({N-[(2-ethoxynaphthalen-1-yl)carbonyl]glycyl}sulfanyl)-D-valine. This impurity was prepared by isolation and was co-injected into the HPLC system to confirm the retention time. To the best of our knowledge, this impurity has not been reported elsewhere. The identification and structural elucidation of this degradant impurity has been discussed in detail.
authors.affiliation: Aurobindo Pharma Limited Research Centre-II, Survey No: 71 & 72, Indrakaran village, Sangareddy mandal, Medak district, 502329, Telangana, India.
authors.forename: Jagadeesh Kumar
authors.initials: JK
authors.lastname: Vundavilli
authors.affiliation: Aurobindo Pharma Limited Research Centre-II, Survey No: 71 & 72, Indrakaran village, Sangareddy mandal, Medak district, 502329, Telangana, India.
authors.forename: Pavan Kumar S R
authors.initials: PK
authors.lastname: Kothapalli
authors.affiliation: Aurobindo Pharma Limited Research Centre-II, Survey No: 71 & 72, Indrakaran village, Sangareddy mandal, Medak district, 502329, Telangana, India.
authors.forename: Badarinadh Gupta
authors.initials: BG
authors.lastname: Peruri
authors.affiliation: Aurobindo Pharma Limited Research Centre-II, Survey No: 71 & 72, Indrakaran village, Sangareddy mandal, Medak district, 502329, Telangana, India.
authors.forename: Prasada Rao V V
authors.initials: PR
authors.lastname: Korrapati
authors.affiliation: Aurobindo Pharma Limited Research Centre-II, Survey No: 71 & 72, Indrakaran village, Sangareddy mandal, Medak district, 502329, Telangana, India.
authors.forename: Hemant Kumar
authors.initials: HK
authors.lastname: Sharma
authors.affiliation: Aurobindo Pharma Limited Research Centre-II, Survey No: 71 & 72, Indrakaran village, Sangareddy mandal, Medak district, 502329, Telangana, India.
authors.forename: Sreenivas
authors.initials: S
authors.lastname: Nallapati
keywords: Characterization; Impurities; Nafcillin Sodium; Stability
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