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Sci. Pharm. 2013, 81(4), 933-950; doi:10.3797/scipharm.1304-14

Isolation and Characterisation of Degradation Impurities in the Cefazolin Sodium Drug Substance

Orchid Chemicals and Pharmaceuticals Limited, Research and Development Centre, Sozhanganallur, Chennai 600 119, Tamilnadu, India
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Received: 15 April 2013 / Accepted: 4 June 2013 / Published: 4 June 2013
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Abstract

Two unknown impurities were detected in the cefazolin sodium bulk drug substance using gradient reversed-phase high-performance liquid chromate-graphy (HPLC). These impurities were isolated by preparative HPLC and characterized by using spectroscopic techniques like LC-MS, LC-MS/MS, 1D, 2D NMR, and FT-IR. Based on the spectral data, the impurities have been characterized as N-(2,2-dihydroxyethyl)-2-(1H-tetrazol-1-yl)acetamide (Impu rity-I) and 2-{carboxy[(1H-tetrazol-1-ylacetyl)amino]methyl}-5-methylidene-5,6-dihydro-2H-1,3-thiazine-4-carboxylic acid (Impurity-II). The structures of these impurities were also established unambiguously by co-injection into HPLC to confirm the retention time. To the best of our knowledge, these two impurities were not reported elsewhere.
Keywords: Cefazolin sodium; Degradation Impurities; LC-MS/MS; NMR; β-Lactam Cefazolin sodium; Degradation Impurities; LC-MS/MS; NMR; β-Lactam
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

SIVAKUMAR, B.; PARTHASARATHY, K.; MURUGAN, R.; JEYASUDHA, R.; MURUGAN, S.; SARANGHDAR, R.J. Isolation and Characterisation of Degradation Impurities in the Cefazolin Sodium Drug Substance. Sci. Pharm. 2013, 81, 933-950.

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