11 DESCRIPTION
Fentanyl Citrate Injection is a Schedule II controlled drug substance and is an opioid agonist. Fentanyl Citrate Injection, USP is a sterile, clear, colorless, non-pyrogenic, preservative free aqueous solution for intravenous or intramuscular injection.
Fentanyl Citrate Injection contains fentanyl citrate as the active pharmaceutical ingredient. The chemical name is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). The molecular weight is 528.60 g/mol. Its molecular formula is C22H28N2O ∙ C6H8O7 and has the following chemical structure.
Each mL of Fentanyl Citrate Injection contains 78.5 mcg of fentanyl citrate (equivalent to 50 mcg fentanyl base), sodium hydroxide (q.s.) as pH adjuster, in water for injection. Fentanyl Citrate Injection pH is between 4.5 to 7.0.