SPL Set ID: ac7ff1eb-6e73-4cc8-9114-c5a4483ad4c3

1 drug(s) with this SPL Set ID

Open DailyMed details

Zoledronic Acid ZOLEDRONIC ACID
4 mg/5 ml Injection
AUROMEDICS PHARMA LLC FDA Rx Only

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: Zoledronic acid monohydrate is a white to off white crystalline powder. Its molecular formula is C 5 H 10 N 2 O 7 P 2 •H 2 O 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 injection is available in 5 mL vials as a sterile clear, colorless 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 24 mg of sodium citrate, USP. Inactive Ingredients: Mannitol USP, water for injection, and sodium citrate USP, as buffering agent. Zoledronic Acid Monohydrate Chemical Structure

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