SPL Set ID: 3853a26d-782d-f4e7-e063-6294a90a6e47

Esmolol hydrochloride injection is a beta adrenergic receptor blocker with a very short duration of action (elimination half-life is approximately 9 minutes). Esmolol hydrochloride is: (±)-Methyl p-[2-hydroxy-3-(isopropylamino) propoxy] hydrocinnamate hydrochloride and has the following structure: Esmolol hydrochloride, USP has the molecular formula C 16 H 26 NO 4 Cl and a molecular weight of 331.8. It has one asymmetric center and exists as an enantiomeric pair. Esmolol hydrochloride, USP is a white to off-white crystalline powder. It is a relatively hydrophilic compound which is very soluble in water and freely soluble in alcohol. Its partition coefficient (octanol/water) at pH 7.0 is 0.42 compared to 17 for propranolol. Esmolol Chemical Structure 11.1 Esmolol Hydrochloride Injection Dosage Forms All Esmolol hydrochloride injection presentations are a clear, colorless to light yellow, sterile, nonpyrogenic solution of esmolol hydrochloride. The formulation for esmolol hydrochloride in sodium chloride injection and esmolol hydrochloride injection is described in the table below: Table 4 Esmolol Hydrochloride Injection Formulations Esmolol Hydrochloride in Sodium Chloride Injection Esmolol Hydrochloride in Sodium Chloride Injection Double Strength Esmolol Hydrochloride Injection Esmolol Hydrochloride, USP 10 mg/mL 20 mg/mL 10 mg/mL Sodium Chloride, USP 5.9 mg/mL 4.1 mg/mL 5.9 mg/mL Water for Injection, USP Q.S. to volume of 250 mL Q.S. to volume of 100 mL Q.S. to volume of 10 mL Sodium Acetate Trihydrate, USP 2.8 mg/mL 2.8 mg/mL 2.8 mg/mL Glacial Acetic Acid, USP 0.546 mg/mL 0.546 mg/mL 0.546 mg/mL Sodium Hydroxide Q.S. to adjust pH to 4.5 to 5.5 Hydrochloric Acid Q.S. to adjust pH to 4.5 to 5.5 Q.S. = Quantity sufficient The calculated osmolarity of esmolol hydrochloride in sodium chloride injection and esmolol hydrochloride in sodium chloride injection double strength is 312 mOsmol/L. The 250 mL and 100 mL bags are non-latex, non-PVC flexible containers with dual polypropylene ports. The flexible containers are manufactured from a specially designed multilayer polypropylene. Solutions in contact with the plastic container leach out certain chemical compounds from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.