Process for the preparation of crystalline clopidogrel hydrogen sulphate Form I
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United States of America Patent
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Issued Date -
Aug 7, 2008
app pub date -
Jan 28, 2008
filing date -
Jan 29, 2007
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Abstract
The present invention describes an improved industrial process for crystallizing polymorph Form I of (+) clopidogrel hydrogen sulphate (also called clopidogrel bisulphate) in either a Type-I solvent or a Type-II. Type I solvent is an organic solvent containing two or more functional groups with a proviso that at least one functional group is different from the other(s). The Type II solvent is selected from methyl ethyl ketone, cyclopentylmethyl ether, dipropylglycolether, dibutylglycol ether, propylmethyl cellosolve, butylmethylcellosolve, propylethylellosolve, butylethylcellosolve or their cross combinations. The process produces Form I in a reproducible manner without detectable contamination of polymorph designated as Form II.
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