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

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

Jagadeesh Kumar Vundavilli, Pavan Kumar S R Kothapalli, Badarinadh Gupta Peruri, Prasada Rao V V Korrapati, Hemant Kumar Sharma, Sreenivas Nallapati

Sci Pharm. 2014 Oct 15;83(1):95-106.

PMID: 26839804

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.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP7177506	Nafcillin sodium		7177-50-6	Price

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