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ZOLEDRONIC ACID INJECTION - CONCENTRATE FOR INTRAVENOUS INFUSION Description (zoledronic acid for injection - CONCENTRATE FOR INTRAVENOUS INFUSION)

11 DESCRIPTION

Zoledronic acid is 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 and its structural formula is:

Chemical Structure

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.

Zoledronic acid is available in 5 mL vials as a sterile liquid solution for dilution prior to intravenous infusion.

  • Each 5 mL solution for dilution prior to intravenous infusion vial contains 4.264 mg zoledronic acid monohydrate, corresponding to 4 mg zoledronic acid on an anhydrous basis, 220 mg of mannitol, USP, water for injection, and sodium citrate, to adjust pH.

Inactive Ingredients: mannitol, USP, as bulking agent, water for injection, and sodium citrate, USP, as buffering agent.

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