SPL Set ID: 60b10020-f802-4fef-a487-0f11eca246c5

Esmolol Hydrochloride 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. Esmolol Hydrochloride is a clear, colorless to light yellow, sterile, non-pyrogenic solution of esmolol hydrochloride. The formulations for Esmolol Hydrochloride are described in the table below: Table 4. Esmolol Hydrochloride Formulations Esmolol Hydrochloride Esmolol Hydrochloride DOUBLE STRENGTH Esmolol Hydrochloride 10 mg/mL 20 mg/mL Ethanol 1% v/v 1% v/v Propylene Glycol 10 mg/mL 10 mg/mL Water for Injection, USP Q.S. to volume of 250 mL Q.S. to volume of 100 mL Sodium Acetate Trihydrate , USP 0.68 mg/mL 0.68 mg/mL Glacial Acetic Acid, USP 0.27 mg/mL 0.27 mg/mL Osmolarity 320 to 450 mOsmol/L 440 to 500 mOsmol/L Sodium Hydroxide Q.S. to adjust pH to 5.0 (4.5 to 6.5) Q.S. = Quantity sufficient 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. structural formula