MSN Laboratories

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MSN Laboratories

• An Improved process technology for the
  production of Terbinafine hydrochloride
  substantially free from Genotoxic impurity
• And
• Montelukast sodium substantially free from
  sulfoxide and cis isomer
• PRESENTED BY S.T. RAJAN AT CPhI PARIS 1ST OCTOBER
  TO 3RD OCTOBER 2006

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GENOTOXIC IMPURITY OF TERBINAFINE HCl

• CHEMICAL NAME (E)-44,4-Dimethyl-pent-yn-(E)-ylid
  ene-N 1,N5-dimethyl-N 1 ,
  N5-bisnaphthalene-1-yl methyl-pent-2-ene-1,5
  diamine (Genotoxic impurity)
• It has been brought to the attention of the IMB
  and other Health Authorities as well as EDQM that
  the said impurity that may be found in
  terbinafine drug substance is considered to be
  mutagenic. The said impurity was evaluated for
  potential mutagenic activity and found acceptable
  levels of cytotoxicity and thus concluded that
  the said impurity is a mutagen under mutagenicity
  conditions, hence it is named as genotoxic.

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IMPURITIES OF MONTELUKAST SODIUM