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Sci. Pharm. 2015, 83(1), 95-106; doi:10.3797/scipharm.1408-03 (registering DOI)

Identification, Isolation, and Characterization of a New Degradation Impurity in Nafcillin Sodium

Aurobindo Pharma Limited Research Centre-II, Survey No: 71 & 72, Indrakaran village, Sangareddy mandal, Medak district, 502329, Telangana, India
Authors to whom correspondence should be addressed.
Received: 4 August 2014 / Accepted: 15 October 2014 / Published: 15 October 2014
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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 1H-NMR, 13C-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-ethoxy-naphthalen-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.
Keywords: Nafcillin Sodium; Stability; Impurities; Characterization Nafcillin Sodium; Stability; Impurities; Characterization
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

VUNDAVILLI, J.K.; KOTHAPALLI, P.K.S.R.; PERURI, B.G.; KORRAPATI, P.R.V.V.; SHARMA, H.K.; NALLAPATI, S. Identification, Isolation, and Characterization of a New Degradation Impurity in Nafcillin Sodium. Sci. Pharm. 2015, 83, 95-106.

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