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Synthesis of Eflornithine Hydrochloride and Related Substances by Novel Process

Sanjeev R Patil, Dattatraya N Pansare*, Ashish Arsondkar, Anil S Bobade and Devanand B Shinde

The synthesis of five related substances/impurities of Eflornithine (5), formed during the preparation of Eflornithine bulk drug, is described. The products are methyl 2,5-diamino- pentanoate HCl (2), methyl 2,5-bis(benzylideneamino)pentanoate (3), 3-aminopiperidin-2-one HCl) (6), 3-amino-3-(difluoromethyl)piperidin-2-one HCl (7) and Dimer Impurity (8). The structures of these compounds were established on the basis of spectral data (IR, 1HNMR, 13CMR and MS).