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Propranolol Hydrochloride Injection
»Propranolol Hydrochloride Injection is a sterile solution of Propranolol Hydrochloride in Water for Injection.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C16H21NO2·HCl.
Packaging and storage—
Preserve in single-dose,light-resistant containers,preferably of Type Iglass.
Identification—
The chromatogram of the Assay preparationobtained as directed in the Assayexhibits a major peak for propranolol,the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparationobtained as directed in the Assay.
Bacterial endotoxins á85ñ—
It contains not more than 55.6USP Endotoxin Units per mg of propranolol hydrochloride.
pHá791ñ:
between 2.8and 4.0.
Other requirements—
It meets the requirements under Injections á1ñ.
Assay—
Mobile phase,Standard preparation,Resolution solution,and Chromatographic system—
Prepare as directed in the Assayunder Propranolol Hydrochloride.
Assay preparation—
Transfer an accurately measured volume of Injection,equivalent to about 5mg of propranolol hydrochloride,to a 25-mLvolumetric flask,dilute with methanol to volume,and mix.
Procedure—
Proceed as directed for Procedurein the Assayunder Propranolol Hydrochloride.Calculate the quantity,in mg,of C16H21NO2·HCl in each mLof the Injection taken by the formula:
25(C/V)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Propranolol Hydrochloride in the Standard preparation,Vis the volume,in mL,of Injection taken,and rUand rSare the propranolol peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information—
Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(PA5)Pharmaceutical Analysis 5
USP28–NF23Page 1660
Phone Number:1-301-816-8305
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