Investigation of a new amoxicillin sodium impurity unstable in solution

Journal of Pharmaceutical and Biomedical Analysis
L ValvoL Giannetti

Abstract

A new amoxicillin sodium impurity was detected by reversed-phase HPLC in commercial injectable preparations only when examined very soon after the drug was dissolved in the solvent vial (within about 10 min). The stability of this impurity was investigated by the degradation kinetic of its aqueous solutions. Ionspray mass spectrometry with flow-injection analysis and HPLC-MS methods were used to establish its nature. Some hypotheses concerning its chemical structure were formulated. The most likely assumption referred to the (5S,6R) amoxicillin piperazinedione diasteroisomer. The presence of the amoxicilloic acid methyl ester, an intermediate of the amoxicillin degradation process, was also hypothesized.

References

Sep 1, 1978·Journal of Pharmaceutical Sciences·A C MunroS R Woroniecki
Mar 1, 1985·Analytical Chemistry·C M WhitehouseJ B Fenn
May 1, 1994·Allergy·J M VegaS Terrados

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Citations

Feb 26, 2010·Journal of Environmental Science and Health. Part A, Toxic/hazardous Substances & Environmental Engineering·Assaf LammDror Avisar

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