Title of Invention | A NOVEL METHOD FOR PREPARING HIGH PURITY ANHYDROUS PAROXETINE HYDROCLORIDE ISOPROPANOL SOLVATE |
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Abstract | A novel form of anhydrous Paroxetine hydrochloride is prepared by dissolving Paroxetine base in ispropanol, which is treated with a solution of hydrougen chloride in isopropanol. 50 to 60% of isopropanol used in the reaction is then distilled at atmospheric pressure. The product thus obtained after drying contains isopropanol not more than 3% and water content which is less than 2.0% The product is found to be stable even after 3 days upon direct exposure t 75% RH at 40C andt the product is unchanged as confirmed by X-ray powder difractogram. The product is also found t be stable for three months as per ICH satiability conditions. |
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Patent Number | 235757 | |||||||||||||||||||||
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Indian Patent Application Number | 614/MUM/2003 | |||||||||||||||||||||
PG Journal Number | 35/2009 | |||||||||||||||||||||
Publication Date | 28-Aug-2009 | |||||||||||||||||||||
Grant Date | 21-Aug-2009 | |||||||||||||||||||||
Date of Filing | 12-Jun-2003 | |||||||||||||||||||||
Name of Patentee | CADILA HEALTHCARE LIMITED | |||||||||||||||||||||
Applicant Address | ZYDUS TOWER, SATELLITE CROSS ROAD, AHMEDABAD-380 015 | |||||||||||||||||||||
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PCT International Classification Number | C07D405/12 | |||||||||||||||||||||
PCT International Application Number | N/A | |||||||||||||||||||||
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