PROCESS FOR PRODUCING PURE AND STABLE FORM OF 2-METHYL-4-(4- METHYL- 1 -PIPERAZINYL)-10H-THIENO[2,3-b] [ 1,5]BENZODIAZEPINE

摘要

Disclosed is an improved process for producing pure and thermally color stable crystalline Form I of 2-methyl-4-(4-methyl-l-piperazinyl)-10H-thieno[2,3-b][l,5] benzodiazepine and product thereof. The process comprises of reacting 2-(2- aminoanilino)-5-methylthiophene-3-carbonitrile with N-methyl piperazine in conjunction with N-methylpiperazine acid salt, to produce 2-methyl-4-(4-methyl-l- piperazinyl)-10H-thieno[2,3-b][l,5] benzodiazepine. Also disclosed is a process for obtaining the Polymorphic Form I of 2-methyl-4-(4-methyl-l-piperazinyl)-10H- thieno[2,3-b][l ,5J benzodiazepine by crystallizing the crude 2-methyl-4-(4-methyl-l- piperazinyl)-10H-thieno [2,3-b][l ,5] benzodiazepine in a mixture of solvents. Further the invention also provides a new polymorph of Olanzapine, dihydrate Form Ji and process for its preparation and a new hydrate Form J<SUB>2</SUB> of Olanzapine having moisture content 1 -3% and process for its preparation.