Procainamide Hydrochloride Injection
»Procainamide Hydrochloride Injection is a sterile solution of Procainamide Hydrochloride in Water for Injection.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of C13H21N3O·HCl.
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass.
Labeling— Label it to indicate that the Injection is not to be used if it is darker than slightly yellow,or is discolored in any other way.
Identification— It responds to the Thin-Layer Chromatographic Identification Test á201ñ,5µLof the clear supernatant being used to prepare the Assay preparationin the Assayand 5µLof the stock solution being used to prepare the Standard preparationin the Assaybeing applied to the plate,and a solvent system consisting of a mixture of ethyl acetate,methanol,and ammonium hydroxide (22:2:1)being used to develop the chromatogram.
Bacterial endotoxins á85ñ— It contains not more than 0.35USP Endotoxin Unit per mg of procainamide hydrochloride.
pHá791ñ: between 4.0and 6.0.
Particulate matter á788ñ: meets the requirements under Small-volume injections.
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 Procainamide Hydrochloride.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 500mg of procainamide hydrochloride,to a 500-mLvolumetric flask,dilute with methanol to volume,and mix.Transfer 5.0mLof this stock solution to a 100-mLvolumetric flask,reserving the remainder of the stock solution for the Identificationtest.Dilute with Mobile phaseto volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Procainamide Hydrochloride.Calculate the quantity,in mg,of C13H21N3O·HCl in each mLof the Injection taken by the formula:
10,000(C/V)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Procainamide Hydrochloride RSin the Standard preparation,Vis the volume,in mL,of Injection taken,and rUand rSare the 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 1625
Phone Number:1-301-816-8305