Patent ID: 7989452

Claim:
A sterile aqueous injectable pharmaceutical composition suitable for parenteral administration comprising a therapeutically effective dose of a hydralazine hydrochloride composition in a pharmaceutically acceptable carrier or diluent, the aqueous injectable pharmaceutical composition further comprising polyethylene glycol and sterile water for injection, wherein said hydralazine hydrochloride composition comprises hydralazine hydrochloride, less than about 1% by weight of phthalazine compounds, less than about 0.0005% hydrazine by weight, and less than about 15 parts per million metal ions, and wherein said pharmaceutical composition has no visible particulate matter 30 months after manufacture, said pharmaceutical composition has less than 6000 10 micron particles per container 30 months after manufacture and said pharmaceutical composition has less than 600 25 micron particles per container 30 months after manufacture.