Zoruxa

Zoruxa Description

zoledronic acid

Manufacturer:

Gland Pharma

Distributor:

Zuellig Pharma

Marketer:

Mega Lifesciences
Full Prescribing Info
Description
Each 100 mL contains Zoledronic acid monohydrate equivalent to Zoledronic acid 5 mg, water for Injection USP q.s to 100 mL.
Zoruxa contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (l-Hydroxy-2-imidazol-l-yl­ phosphonoethyl) phosphonic acid monohydrate.
Zoledronic acid monohydrate is a white crystalline powder. Its molecular formula is C5H10N2O7P2•H2O and a molar mass of 290.1 g/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.
Zoledronic Acid Injection is available in vials as a sterile liquid concentrate solution for intravenous infusion. Each 100 ml vial contains 5.330 mg of Zoledronic Acid monohydrate, corresponding to 5 mg Zoledronic acid on an anhydrous basis.
Excipients/Inactive Ingredients: Mannitol USP as Tonicity Agent, Sodium Citrate Dihydrate USP as Buffering Agent and Water for Injection USP as solvent.
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