Patent ID: 7642271

Claim:
An aqueous, stable, injectable, sterile pharmaceutical solution comprising: a) 0.5 to 10 mg/mL 1-[5-[(aminoiminomethyl)amino]-1-oxo-2-[[(1,2,3,4-tetrahydro-3-methyl-8-quinolinyl)sulfonyl]amino]pentyl]-4-methyl-2- piperidinecarboxylic acid hydrate (argatroban); b) 0.01 to 3 N acid to solubilize the argatroban, wherein the acid comprises at least one of phosphoric acid, acetic acid, tartaric acid, citric acid, formic acid, malic acid and hydrochloric acid; c) a buffering agent to maintain the solution at a pH of 4.5 to 5.5; and d) 1 to 100 mg/ml osmotic-adjusting agent, wherein the pharmaceutical solution is stable for at least 24 months and is free from dehydrated alcohol and free from saccharides.