Nalorphine Hydrochloride Injection
» Nalorphine Hydrochloride Injection is a suitably buffered, sterile solution of Nalorphine Hydrochloride in Water for Injection. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of nalorphine hydrochloride (C19H21NO3·HCl).
Packaging and storage— Preserve in single-dose or in multiple-dose containers, preferably of Type I glass.
Identification— Apply 15 µL of Injection and 15 µL of a Standard solution of USP Nalorphine Hydrochloride RS in methanol containing 5 mg per mL to a suitable thin-layer chromatographic plate (see Chromatography 621) 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 UV light: the RF value of the principal spot obtained from the Injection corresponds to that obtained from the Standard solution.
Bacterial endotoxins 85 It contains not more than 11.6 USP Endotoxin Units per mg of nalorphine hydrochloride.
pH 791: between 6.0 and 7.5.
Other requirements— It meets the requirements under Injections 1.
Assay— Transfer an accurately measured volume of Injection, equivalent to about 10 mg of nalorphine hydrochloride, to a 25-mL centrifuge separator, add 1 mL of 3 N hydrochloric acid, and dilute with water to about 10 mL. Extract with five 5-mL portions 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-mL volumetric flask with the aid of water, dilute with water to volume, and mix. Proceed as directed in the Assay under Nalorphine Hydrochloride, beginning with “Concomitantly determine the absorbances.” Calculate the quantity, in mg, of C19H21NO3·HCl in each mL of the Injection taken by the formula:
(0.1C / V)(AU / AS)
in which V is the volume, in mL, of Injection taken, and C, AU, and AS are as defined therein.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Clydewyn M. Anthony, Ph.D.
(MDCCA05) Monograph Development-Cough Cold and Analgesics
Reference Standards Lili Wang, Technical Services Scientist
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3026