Nalorphine Hydrochloride Injection
»Nalorphine Hydrochloride Injection is a suitably buffered,sterile solution of Nalorphine Hydrochloride in Water for Injection.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of Nalorphine Hydrochloride (C19H21NO3·HCl).
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass.
Identification— Apply 15µLof Injection and 15µLof a Standard solution of USP Nalorphine Hydrochloride RSin methanol containing 5mg per mLto a suitable thin-layer chromatographic plate (see Chromatography á621ñ)coated with a 0.25-mm layer of chromatographic silica gel mixture.Allow the applications to dry,and develop the chromatogram in an equilibrated chamber containing methanol until the solvent front has moved about three-fourths of the length of the plate.Remove the plate from the developing chamber,mark the solvent front,and allow the solvent to evaporate.Observe the plate under short-and long-wavelength UVlight:the RFvalue of the principal spot obtained from the Injection corresponds to that obtained from the Standard solution.
Bacterial endotoxins á85ñ It contains not more than 11.6USP Endotoxin Units per mg of nalorphine hydrochloride.
pHá791ñ: between 6.0and 7.5.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Transfer an accurately measured volume of Injection,equivalent to about 10mg of nalorphine hydrochloride,to a 25-mLcentrifuge separator,add 1mLof 3Nhydrochloric acid,and dilute with water to about 10mL.Extract with five 5-mLportions of chloroform,separating the layers by centrifugation before drawing off each chloroform extract,and discard the chloroform extracts.Transfer the aqueous layer to a 100-mLvolumetric flask with the aid of water,dilute with water to volume,and mix.Proceed as directed in the Assayunder Nalorphine Hydrochloride,beginning with “Concomitantly determine the absorbances.”Calculate the quantity,in mg,of C19H21NO3·HCl in each mLof the Injection taken by the formula:
in which Vis the volume,in mL,of Injection taken,and C,AU,and ASare as defined therein.
Auxiliary Information— Staff Liaison:Daniel K.Bempong,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 1328
Phone Number:1-301-816-8143