Montelukast EP Impurity F also known as Montelukast Related Compound E;Montelukast Methyl ketone, in various pharmacopoeias, is a highly characterized standard. It meets strict regulatory requirements set by USP, EMA, JP, and BP, making it a crucial component in Abbreviated New Drug Applications (ANDA), New Drug Applications (NDA), and the commercial production of Montelukast.
References
Emerce, Esra, et al. “Determination of the Impurities in Drug Products Containing Montelukast and in Silico/in Vitro Genotoxicological Assessments of Sulfoxide Impurity.†Toxicology Letters, vol. 238, no. 2, Oct. 2015, pp. 90–99, https://doi.org/10.1016/j.toxlet.2015.07.003. ? Wang, D. “Simultaneous Determination of Montelukast Sodium S-Enantiomer and A5 Enantiomers in Montelukast Sodium Bulk Drug by Normal-Ph
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