Oxymorphone Hydrochloride Injection
» Oxymorphone Hydrochloride Injection is a sterile solution of Oxymorphone Hydrochloride in Water for Injection. It contains not less than 93.0 percent and not more than 107.0 percent of the labeled amount of C17H19NO4·HCl.
Packaging and storage— Preserve in single-dose or in multiple-dose containers of Type I glass, protected from light.
Identification— The solution prepared for measurement of absorbance in the Assay exhibits maxima and minima at the same wavelengths as the Standard preparation prepared as directed in the Assay.
Bacterial endotoxins 85 It contains not more than 238.1 USP Endotoxin Units per mg of oxymorphone hydrochloride.
pH 791: between 2.7 and 4.5.
Other requirements— It meets the requirements under Injections 1.
Standard preparation— Transfer about 45 mg of USP Oxymorphone RS, accurately weighed, to a 50-mL volumetric flask, dissolve in about 10 mL of chloroform, dilute with chloroform to volume, and mix. Transfer 15.0 mL of this solution to a 100-mL volumetric flask, dilute with chloroform to volume, and mix. The concentration of USP Oxymorphone RS in the Standard preparation is about 135 µg per mL.
Assay preparation— Transfer an accurately measured volume of Injection, equivalent to about 15 mg of oxymorphone hydrochloride, to a 125-mL separator, and add water, if necessary, to bring the volume to 15 mL. Adjust by the addition of hydrochloric acid to a pH of less than 2, extract with five 15-mL portions of chloroform, and discard the chloroform extracts. Adjust the aqueous phase with ammonium hydroxide to a pH of 9.5, and extract with four 20-mL portions of chloroform. Filter the chloroform extracts through a chloroform-moistened pledget of cotton into a 100-mL volumetric flask, dilute with chloroform to volume, and mix.
Procedure— Concomitantly determine the absorbances of the solutions in 1-cm cells at the wavelength of maximum absorbance at about 282 nm, with a suitable spectrophotometer, using chloroform as the blank. Calculate the quantity, in mg, of C17H19NO4·HCl in each mL of the Injection taken by the formula:
(337.80 / 301.34)(0.1C / V)(AU / AS)
in which 337.80 and 301.34 are the molecular weights of oxymorphone hydrochloride and oxymorphone, respectively; C is the concentration, in µg per mL, of USP Oxymorphone RS in the Standard preparation; V is the volume, in mL, of Injection taken; and AU and AS are the absorbances of the Assay preparation and the Standard preparation, respectively.
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 3177