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MSN Laboratories

GENOTOXIC IMPURITY OF TERBINAFINE HCl. CHEMICAL NAME: (E)-4[4,4-Dimethyl-pent-yn-(E)-ylidene]-N* 1*,N*5-dimethyl-N* 1* , N*5*-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 th

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MSN Laboratories

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    1. 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

    2. GENOTOXIC IMPURITY OF TERBINAFINE HCl CHEMICAL NAME: (E)-4[4,4-Dimethyl-pent-yn-(E)-ylidene]-N* 1*,N*5-dimethyl-N* 1* , N*5*-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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