Quetiapine Hemifumarate Purification by Crystallization
AssigneeFermion Oy
InventorsArme Grumann, Soini Huhta, Petteri Rummakko, Viesturs Lusis
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Abstract
The present invention relates to a process for preparing and purifying crystalline quetiapine hemifumarate, which comprises preparing crystalline quetiapine hemifumarate via a crystalline salt, which is not a salt of fumaric acid.
Claims13
A process for preparing crystalline quetiapine hemifumarate comprising the steps:
- a) crystallizing quetiapine first salt from a suitable solvent and;
- b) converting the first salt to quetiapine hemifumarate.
A process for crystallizing quetiapine hemifumarate comprising a) dissolving quetiapine base in a solvent;
- b) converting quetiapine to the first quetiapine salt;
- c) cooling the mixture to precipitate the first quetiapine salt;
- d) isolating the first quetiapine salt;
- and e) converting the first quetiapine salt to quetiapine hemifumarate.
A process for purifying quetiapine hemifumarate comprising a) dissolving crude quetiapine hemifumarate in a solvent;
- b) optionally liberating quetiapine base from quetiapine hemifumarate;
- c) converting quetiapine to the first quetiapine salt;
- d) cooling the mixture to precipitate the first quetiapine salt;
- e) isolating the first quetiapine salt;
- and f) converting the first quetiapine salt to quetiapine hemifumarate.
Quetiapine hemifumarate not containing detectable amount of 2-(4-dibenzo[b,f]thiazepin-11-yl-piperazin-1-yl) made by using 2-(2-chloroethoxy)ethanol or 2-hydroxyethoxyethylpiperazine as raw material.
Dependencies are inferred from the claim text.