Each vial contains: Zoledronic acid Monohydrate equivalent to Zoledronic acid 4 mg, Water for injection USP q.s.
Zinvel 4 mg/5ml solution for Intravenous infusion contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate.
Zoledronic acid is a white crystalline powder. Its molecular formula is C5H10N2O7P2•H2O and its molar mass is 290.1 g/Mol. Zoledronic acid is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid, and practically insoluble in organic solvents. The pH of a 0.7% solution of zoledronic acid in water is approximately 2.0.
It is available in vials as a sterile liquid concentrate solution for intravenous infusion. Each 5-mL vial contains 4.264 mg of zoledronic acid monohydrate, corresponding to 4 mg zoledronic acid as an anhydrous basis.
Excipients/Inactive Ingredients: Mannitol USP, Sodium citrate USP, Water for injection USP.