SPL Set ID: 59ba978b-a393-421c-9a67-77e690249d88

Esmolol Hydrochloride in Sodium Chloride 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 has the empirical 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 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 17.0 for propranolol. 11.1 Esmolol Hydrochloride in Sodium Chloride Injection Dosage Forms All esmolol hydrochloride in sodium chloride injection presentations are clear, colorless to light yellow, sterile, non-pyrogenic, iso-osmotic solutions of esmolol hydrochloride in sodium chloride. The formulations for esmolol hydrochloride in sodium chloride injection [10 mg/mL] [250 mL] and esmolol hydrochloride in sodium chloride injection [20 mg/mL] [100 mL] are described in the table below: Table 4. Esmolol Hydrochloride in Sodium Chloride Injection Formulations Esmolol Hydrochloride in Sodium Chloride Injection (10 mg/mL)[250 mL] Esmolol Hydrochloride in Sodium Chloride Injection (20 mg/mL)[100 mL] DOUBLE STRENGTH Esmolol Hydrochloride 10 mg/mL 20 mg/mL Sodium Chloride, USP 5.9 mg/mL 4.1 mg/mL Water for Injection, USP Q.S. to volume of 250 mL Q.S. to volume of 100 mL Sodium Acetate Trihydrate, USP 2.8 mg/mL 2.8 mg/mL Glacial Acetic Acid, USP 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 [10 mg/mL] [250 mL] and esmolol hydrochloride in sodium chloride injection [20 mg/mL] [100 mL] is 312 mOsmol/L. The 250 mL and 100 mL dual port bags have an aluminum overwrap and the container closure is not made with natural rubber latex. 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. Esmolol Hydrochloride Structural Formula