Process for preparation of substantially pure polymorphic form i of olanzapine
AssigneeTomasz Kozluk Nobilus Ent
InventorTomasz Kozluk
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Abstract
A process for preparation of substantially pure polymorphic Form I of olazapine consists in that olanzapine starting material is subjected to: a) at least one digestion step in an acidic aqueous medium, with an optional addition of active charcoal, and then to neutralizing to pH within the range from about 6.0 to about 11.0, and b) at least one step of separation of impurities in a water—organic solvent system, followed by crystallization from the solution in methylene chloride, and wherein steps a) and b) are separated by steps of isolation of precipitate of olanzapine and can be accomplished in any order.
Claims18
A process for preparation of substantially pure polymorphic Form I of olanzapine, characterized in that olanzapine starting material is subjected to:
- a) at least one digestion step in an acidic aqueous medium, with optional addition of active charcoal, and then neutralizing to pH within the range from about 6.0 to about 11.0, and
- b) at least one step of impurities separation in a water—organic solvent system,
- followed by crystallization from the solution in methylene chloride,
- and wherein the steps a) and b) are separated by steps of isolation of precipitate of olanzapine and can be accomplished in any order.
Substantially pure polymorphic Form I of olanzapine containing less than 0.10% impurity S, prepared by the method according to any of the preceding claims.
Dependencies are inferred from the claim text.