Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry and Computational Chemistry

Abstract

Synthesis and Characterisation of Fingolimod Impurities: A Drug for Multiple Sclerosis

Author(s): Maruthi Raju N, Venkateswara Rao B, Siddaiah V

Fingolimod (1) is an immunomodulating drug, frequently used for treating Multiple Sclerosis (MS) approved by the US-FDA. During the process development of Fingolimod, some process related impurities were observed along with the final API. These impurities were identified as N,N-dimethyl (2), N-methyl (3), nitromono methyl (4), monomethyl (5), nitrohydroxy (6) and hydroxy (7) impurities. The present work describes the synthesis and characterization of these impurities.


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