High purity butoconazole nitrate with specified particle size and a process for the preparation thereof

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 proce...

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Bibliographische Detailangaben
Hauptverfasser: Czibula, Laszlo, Dobay, Laszlo, Werkne Papp, Eva, Nagyne Bagdy, Judit, Sebok, Ferenc
Format: Patent
Sprache:eng
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Beschreibung
Zusammenfassung: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.