SPL Set ID: b5143563-ff45-433a-a9e2-f8b8340db1f5

Argatroban is a synthetic direct thrombin inhibitor and the chemical name is 1-[5 [(aminoiminomethyl) amino]-1-oxo-2-[[(1, 2, 3, 4-tetrahydro-3-methyl-8- quinolinyl) sulfonyl] amino] pentyl]-4-methyl-2-piperidinecarboxylic acid, monohydrate. Argatroban has 4 asymmetric carbons. One of the asymmetric carbons has an R configuration (stereoisomer Type I) and an S configuration (stereoisomer Type II). Argatroban consists of a mixture of R and S stereoisomers at a ratio of approximately 65:35. The molecular formula of argatroban is C 23 H 36 N 6 O 5 S•H 2 O. Its molecular weight is 526.66 g/mol. The structural formula is shown below: Argatroban is a white, odorless crystalline powder that is freely soluble in glacial acetic acid, slightly soluble in ethanol, and insoluble in acetone, ethyl acetate, and ether. Argatroban Injection 50 mg/50 mL (1 mg/mL) is a sterile clear, colorless to pale yellow, solution. Argatroban 50 mg/50 mL (1 mg/mL) is available in 50-mg (in 50- mL) single-dose clear vials, with flip-off seals. Each mL of sterile, non-pyrogenic solution contains 1 mg Argatroban. Inert ingredients (per vial): 260 mg Propylene glycol, 152 mg Dehydrated alcohol, and 450 mg Sodium Chloride. argatroban-injection-1