SPL Set ID: 4cfdfa50-579b-43e7-bc0a-e831d3099bfd

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, USP is: 4-[2-Hydroxy –3-[(1-methylethyl)amino]-propoxy]benzenepropanoic acid methyl ester hydrochloride and has the following structure: Esmolol hydrochloride, USP has the molecular formula C 16 H 25 NO 4 .HCl and a molecular weight of 331.83 g/mol. 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 3.0 to 5.0 is 1.7. 12 11.1 Esmolol Hydrochloride in Sodium Chloride Injection Dosage Form Esmolol hydrochloride in sodium chloride injection is clear, colorless to light yellow, sterile, nonpyrogenic, iso-osmotic solution. The formulations for esmolol hydrochloride in sodium chloride injection, 2,500 mg/250 mL (10 mg/mL) and esmolol hydrochloride in sodium chloride injection [DOUBLE STRENGTH], 2,000 mg/100 mL (20 mg/mL) are described in the table below: Table 4: Esmolol Hydrochloride in Sodium Chloride Injection Formulations Esmolol Hydrochloride in Sodium Chloride Injection Esmolol Hydrochloride in Sodium Chloride Injection [DOUBLE STRENGTH] Esmolol Hydrochloride, USP 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 5.0 (4.5 to 5.5) Hydrochloric Acid Q.S. to adjust pH to 5.0 (4.5 to 5.5) Q.S. = Quantity sufficient The calculated osmolarity of esmolol hydrochloride in sodium chloride injection, 2,500 mg/250 mL (10 mg/mL) and esmolol hydrochloride in sodium chloride injection [DOUBLE STRENGTH] 2,000 mg/100 mL (20 mg/mL) is 312 mOsmol/L. The 250 mL and 100 mL Magiflex bags are non-latex, non-PVC with dual PP ports. 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.