Hydromorphone Hydrochloride Injection
»Hydromorphone Hydrochloride Injection is a sterile solution of Hydromorphone Hydrochloride in Water for Injection.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of hydromorphone hydrochloride (C17H19NO3·HCl).
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass,protected from light.
Identification— Place a volume of Injection,equivalent to about 10mg of hydromorphone hydrochloride,in a separator.Extract with four 10-mLportions of chloroform,and discard the extracts.Add 1mLof sodium carbonate TS,and extract with three 10-mLportions of chloroform.Filter the chloroform extracts into a glass-stoppered,50-mLflask,and evaporate on a steam bath with the aid of a current of air to dryness.Dissolve the residue in 1mLof chloroform:the IRabsorption spectrum of the solution so obtained exhibits maxima only at the same wavelengths as that of a similar preparation of USP Hydromorphone Hydrochloride RS.
Bacterial endotoxins á85ñ— It contains not more than 88.0USP Endotoxin Units per mg of hydromorphone hydrochloride.
pHá791ñ: between 3.5and 5.5.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Standard preparation— Using an accurately weighed quantity of USP Hydromorphone Hydrochloride RS,prepare a solution in water having a known concentration of about 0.2mg per mL.
Assay preparation— Quantitatively dilute an accurately measured volume of Injection,if necessary,with water to obtain a solution containing about 0.2mg per mL.
Procedure— Transfer 20.0mLeach of the Standard preparationand the Assay preparationto separate 50-mLvolumetric flasks.To each flask add,with mixing,1.0mLof hydrochloric acid and 1.0mLof sodium nitrite solution (1in 20).Insert the stoppers,allow to stand for 40to 45minutes,with occasional swirling,then add 2mLof ammonium hydroxide,and mix.Allow to stand for 2minutes,then dilute with water to volume,and mix.Concomitantly determine the absorbances of the solutions in 1-cm cells at the wavelength of maximum absorbance at about 440nm,with a suitable spectrophotometer,using water as the blank.Calculate the quantity,in mg,of hydromorphone hydrochloride (C17H19NO3·HCl)in each mLof the Injection taken by the formula:
(VA/VI)(C)(AU/AS),
in which VAis the volume,in mL,of the Assay preparation;VIis the volume,in mL,of Injection taken to prepare the Assay preparation;Cis the concentration,in mg per mL,of USP Hydromorphone Hydrochloride RSin the Standard preparation;and AUand ASare the absorbances of the solutions from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 973
Phone Number:1-301-816-8139