Reclast
Reclast®
(zoledronic acid) Injection
Solution for Intravenous Infusion
DRUG DESCRIPTION
Reclast® contains zoledronic acid which in solution is available as zoledronate at physiological pH. Zoledronate is a bisphosphonate that inhibits osteoclast-mediated bone resorption. The parent compound from which zoledronate is prepared is zoledronic acid monohydrate which is designated chemically as (1-hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is
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Zoledronic acid monohydrate is a white crystalline powder with the molecular formula of C5H10N2O7P2 • H2O and a molar mass of 290.1g/Mol. Zoledronic acid monohydrate 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.
Reclast® (zoledronic acid) Injection is available as a sterile solution in bottles for intravenous infusion. One bottle with 100 mL solution contains 5.330 mg of zoledronic acid monohydrate, equivalent to 5 mg zoledronic acid on an anhydrous basis. Inactive Ingredients: mannitol, USP, as bulking agent, and sodium citrate, USP, as buffering agent, water for injection, USP. Zoledronic acid is marketed for oncology indications under the brand name Zometa® (zoledronic acid) Injection 4 mg concentrate for intravenous infusion.
Generic Name: Zoledronic Acid Injection
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