Quantification of Genotoxic Alkylating Impurity Butyl3-Methyl-3-(6-methoxy-2-naphtyl) Glycidate at ppm Level by LCMS/MS in Naproxen Drug Substance

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Quantification of Genotoxic Alkylating Impurity Butyl3-Methyl-3-(6-methoxy-2-naphtyl) Glycidate at ppm Level by LCMS/MS in Naproxen Drug Substance

Journal Title: UNKNOWN - Year 2013, Vol 2, Issue 12

Abstract

The objective of present research work is to develop a suitable LCMS/MS method for the quantitative determination of suspected genotoxic impurity namely Sec. Butyl 3-methyl-3-(6-methoxy-2-naphtyl) glycidate present in Naproxen drug substance at ppm level. The LCMS/MS method was developed on Luna C18, 50 mm column using the mobile phase consists a mixture of 10 mM Ammoinium acetate and Acetonirile with isocratic composition of 10:90 at a flow rate of 0.8 mL/min respectively. Ion source is electospray ionization (ESI) positive mode, source temperature is 350

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EP ID EP339137
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