Propranolol Hydrochloride Injection
» Propranolol Hydrochloride Injection is a sterile solution of Propranolol Hydrochloride in Water for Injection. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C16H21NO2·HCl.
Packaging and storage Preserve in single-dose, light-resistant containers, preferably of Type I glass.
USP Reference standards 11
USP Endotoxin RS
USP Propranolol Hydrochloride RS
Identification The chromatogram of the Assay preparation obtained as directed in the Assay exhibits a major peak for propranolol, the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation obtained as directed in the Assay.
Bacterial endotoxins 85 It contains not more than 55.6 USP Endotoxin Units per mg of propranolol hydrochloride.
pH 791: between 2.8 and 4.0.
Other requirements It meets the requirements under Injections 1.
Mobile phase, Standard preparation, Resolution solution, and Chromatographic system Prepare as directed in the Assay under Propranolol Hydrochloride.
Assay preparation Transfer an accurately measured volume of Injection, equivalent to about 5 mg of propranolol hydrochloride, to a 25-mL volumetric flask, dilute with methanol to volume, and mix.
Procedure Proceed as directed for Procedure in the Assay under Propranolol Hydrochloride. Calculate the quantity, in mg, of C16H21NO2·HCl in each mL of the Injection taken by the formula:
25(C / V)(rU / rS)in which C is the concentration, in mg per mL, of USP Propranolol Hydrochloride in the Standard preparation, V is the volume, in mL, of Injection taken, and rU and rS are the propranolol peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 4464