High purity butoconazole nitrate with specified particle size and a process for the preparation thereof
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United States of America Patent
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Dec 1, 2009
Grant Date -
Sep 11, 2008
app pub date -
Jan 25, 2005
filing date -
Jan 27, 2004
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Abstract
One object of the invention is high purity butoconazole nitrate of the formula (I) (I) containing maximum 0.1 wt % of chemical impurities, wherein at least 95% of the particles of the substance are below 75 μm by diameter, whereas at least 99% of the particles are below 250 μm by diameter, and process for its preparation. A pharmaceutical composition comprising as active ingredient, high purity butoconazole nitrate of specified particle size in admixture with known auxiliaries is also within the scope of the invention.
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