Bretylium Tosylate in Dextrose Injection
»Bretylium Tosylate in Dextrose Injection is a sterile solution of Bretylium Tosylate and Dextrose in Water for Injection.It contains not less than 95.0percent and not more than 105.0percent of the labeled amounts of bretylium tosylate (C18H24BrNO3S)and dextrose (C6H12O6·H2O).It contains no antimicrobial agents.
Packaging and storage—
Preserve in single-dose glass or plastic containers.Glass containers are preferably of Type Ior Type IIglass.
Identification—
A:
The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparationas obtained in the Assay for bretylium tosylate.
Bacterial endotoxins á85ñ—
It contains not more than 0.20USP Endotoxin Unit per mg of bretylium tosylate.
pHá791ñ:
between 3.0and 6.5.
Other requirements—
It meets the requirements under Injections á1ñ.
Assay for bretylium tosylate—
pH3.1tetramethylammonium phosphate buffer,Mobile phase,Standard preparation,and Chromatographic system—
Proceed as directed in the Assayunder Bretylium Tosylate Injection.
Assay preparation—
Transfer an accurately measured volume of Injection,equivalent to about 10mg of bretylium tosylate,to a 50-mLvolumetric flask,dilute with water to volume,and mix.
Procedure—
Separately inject equal volumes (about 20µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of bretylium tosylate (C18H24BrNO3S)in each mLof the Injection taken by the formula:
50(C/V)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Bretylium Tosylate RSin the Standard preparation;Vis the volume,in mL,of Injection taken;and rUand rSare the bretylium peak responses from the Assay preparationand the Standard preparation,respectively.
Assay for dextrose—
Transfer an accurately measured volume of Injection,containing 2to 5g of dextrose,to a 100-mLvolumetric flask.Add 0.2mLof 6Nammonium hydroxide,dilute with water to volume,and mix.Determine the angular rotation in a suitable polarimeter tube at 25
(see Optical Rotation á781ñ).The observed rotation,in degrees,multiplied by 1.0425A,in which Ais the ratio 200divided by the length,in mm,of the polarimeter employed,represents the weight,in g,of dextrose (C6H12O6·H2O)in the volume of Injection taken.
(see Optical Rotation á781ñ).The observed rotation,in degrees,multiplied by 1.0425A,in which Ais the ratio 200divided by the length,in mm,of the polarimeter employed,represents the weight,in g,of dextrose (C6H12O6·H2O)in the volume of Injection taken.
Auxiliary Information—
Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(PA5)Pharmaceutical Analysis 5
USP28–NF23Page 280
Pharmacopeial Forum:Volume No.30(5)Page 1589
Phone Number:1-301-816-8305