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ZOLEDRONIC ACID INJECTION - PREMIXED SOLUTION FOR INTRAVENOUS INFUSION (FOR SINGLE DOSE) Description (zoledronic acid for injection - PREMIXED SOLUTION FOR INTRAVENOUS INFUSION (FOR SINGLE DOSE))

11 DESCRIPTION

Zoledronic Acid Injection 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 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 290.1g/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 Injection is available in 100-mL polypropylene, non-DEHP bags as a sterile liquid premixed solution for intravenous infusion. In addition, the bags are not made with natural rubber latex.

  • Each 100 mL premixed bag contains 4.264 mg zoledronic acid monohydrate, corresponding to 4 mg zoledronic acid on an anhydrous basis, 900 mg of sodium chloride, USP, 220 mg of mannitol, USP, water for injection and 24 mg of sodium citrate, USP.
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