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.
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.
Assay
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.
Auxiliary Information
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USP35NF30 Page 4464
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