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      Study on Isomeric Impurities in Cefotiam Hydrochloride

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          Abstract

          In this study, two isomeric impurities were identified in cefotiam hydrochloride injection preparation and were characterized. Column-switching HPLC-MS and NMR techniques were used to identify the impurity 1 as the Δ3(4) isomers of cefotiam. Using software-based calculations, it was predicted that neither of the isomeric impurities was embryotoxic. This study provides a reference for the production, storage, and quality control of cefotiam and related cephalosporin antibiotics.

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          Most cited references13

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          A systematic toxicity evaluation of cephalosporins via transcriptomics in zebrafish and in silico ADMET studies

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            Degradation kinetics and isomerization of cefdinir, a new oral cephalosporin, in aqueous solution. 1.

            Hydrolytic degradation products of cefdinir were studied in acidic (pH 1), neutral (pH 6), and basic (pH 9) solutions. Seven major degradation products were isolated by preparative and/or high-performance liquid chromatography and characterized by UV, IR, 1H-NMR, and mass spectra. To clarify degradation pathways in each pH solution, kinetic and product analyses during hydrolysis of cefdinir were carried out along with the followup reaction of representative degradation products. Cefdinir was shown to degrade via two major degradation routes: beta-lactam ring-opening and pH-dependent isomerizations (lactonization, epimerization at C-6 or C-7, syn-anti isomerization of N-oxime function).
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              United States Pharmacopoeia

              (2017)
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                Author and article information

                Contributors
                Journal
                Front Chem
                Front Chem
                Front. Chem.
                Frontiers in Chemistry
                Frontiers Media S.A.
                2296-2646
                15 January 2021
                2020
                : 8
                : 619307
                Affiliations
                National Institutes for Food and Drug Control , Beijing, China
                Author notes

                Edited by: Alberto Salomone, University of Turin, Italy

                Reviewed by: Gabriella Massolini, University of Pavia, Italy; Juan Manuel Lázaro-Martínez, University of Buenos Aires, Argentina

                *Correspondence: Shang-chen Yao Chunmei_Liu@ 123456hmci.honda.com.cn

                This article was submitted to Analytical Chemistry, a section of the journal Frontiers in Chemistry

                †These authors have contributed equally to this work

                Article
                10.3389/fchem.2020.619307
                7873999
                a7d82c92-6e93-4ce5-8e7c-8cc525fb9672
                Copyright © 2021 Tian, Chong, Liu, Han, Hu, Yao and Xu.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 20 October 2020
                : 15 December 2020
                Page count
                Figures: 5, Tables: 4, Equations: 0, References: 14, Pages: 7, Words: 3666
                Categories
                Chemistry
                Original Research

                cefotiam hydrochloride,column switching,hplc-ms,isomer,nuclear magnetic resonance

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