Papaverine Hydrochloride Injection
»Papaverine Hydrochloride Injection is a sterile solution of Papaverine Hydrochloride in Water for Injection.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of C20H21NO4·HCl.
Packaging and storage—
Preserve in single-dose or multiple-dose containers,preferably of Type Iglass.
Identification—
A:
Add 2mLof alcohol to 1mLof Injection,and evaporate on a steam bath,with the aid of a stream of nitrogen,to dryness.Dry the residue at 105
for 2hours:it responds to Identificationtest Aunder Papaverine Hydrochloride.
for 2hours:it responds to Identificationtest Aunder Papaverine Hydrochloride.
Bacterial endotoxins á85ñ—
It contains not more than 2.9USP Endotoxin Units per mg of papaverine hydrochloride.
pHá791ñ:
not less than 3.0.
Other requirements—
It meets the requirements under Injections á1ñ.
Assay—
Transfer 1.0mLof Injection to a 200-mLvolumetric flask,and dilute with water to volume.Pipet 3mLof this solution into a separator,add 10mLof water,and render alkaline with 6Nammonium hydroxide.Extract the alkaloid with successive 5-mLportions of chloroform,and evaporate the extracts to dryness.Dissolve the residue in 0.1Nhydrochloric acid,and dilute with the same medium to 100.0mL.Concomitantly determine the absorbances of this solution and of a Standard solution of USP Papaverine Hydrochloride RSin 0.1Nhydrochloric acid having a known concentration of about 4.5µg per mLin 1-cm cells at the wavelength of maximum absorbance at about 251nm,with a suitable spectrophotometer,using 0.1Nhydrochloric acid as the blank.Calculate the quantity,in mg,of C20H21NO4·HCl in the portion of Injection taken by the formula:
6.67C(AU/AS),
in which Cis the concentration,in µg per mL,of USP Papaverine Hydrochloride RSin the Standard solution,and AUand ASare the absorbances of the solution from the Injection and the Standard solution,respectively.
Auxiliary Information—
Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(PA5)Pharmaceutical Analysis 5
USP28–NF23Page 1466
Phone Number:1-301-816-8305