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US Patent 9732043 Process for preparing 5-amino-2,3-dihydrophthalazine-1,4-dione monosodium salt

Patent 9732043 was granted and assigned to Bach Pharma on August, 2017 by the United States Patent and Trademark Office.

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Patent
Patent

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Patent Applicant
Bach Pharma
Bach Pharma
Current Assignee
Bach Pharma
Bach Pharma
Patent Jurisdiction
United States Patent and Trademark Office
United States Patent and Trademark Office
Patent Number
9732043
Date of Patent
August 15, 2017
Patent Application Number
14615704
Date Filed
February 6, 2015
Patent Primary Examiner
‌
Douglas M Willis
Patent abstract

The present invention comprises methods of manufacturing a highly purified, pharmaceutical grade phthalazinedione (for example, 5-amino-2,3-dihydrophthalazine-1,4-dione) for administration to a human or animal. The manufacturing methods identify and isolate starting materials (for example, 3-nitrophthalic acid), and prepare intermediate products (for example, 3-nitrophthalhydrazide), which are suitable for the commercial batch process production of highly purified and high-yielding intermediate products and final phthalazinedione products. In an embodiment, a solution of 3-nitrophthalhydrazide and sodium hydroxide in water is prepared and hydrogenated to yield 5-amino-2,3-dihydrophthalazine-1,4-dione.

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