Anileridine Injection
»Anileridine Injection is a sterile solution of Anileridine in Water for Injection,prepared with the aid of Phosphoric Acid.It contains not less than 90.0percent and not more than 115.0percent of the labeled amount of anileridine (C22H28N2O2),as the phosphate.
Packaging and storage— Preserve in single-dose or multiple-dose containers,preferably of Type Iglass,protected from light.
Identification—
A: Dilute a volume of Injection,equivalent to about 1.25mg of anileridine,with water to 5mL,and add 2mLof a 1in 100solution of p-dimethylaminobenzaldehyde in alcohol:a yellow color develops immediately.
B: Avolume of Injection,diluted with water to a concentration of about 25mg of anileridine in 1000mL,exhibits absorbance maxima at 234±1and 285±2nm.
Bacterial endotoxins á85ñ— It contains not more than 7.2USP Endotoxin Units per mg of anileridine.
pHá791ñ: between 4.5and 5.0.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Standard preparation— [NOTE—Prepare on the day of the assay.]Dissolve an accurately weighed quantity of USP Anileridine Hydrochloride RSin 0.1Nhydrochloric acid,and quantitatively dilute with the same solvent to obtain a solution having a known concentration of about 250µg per mL.(Each mg of anileridine hydrochloride is equivalent to 0.8286mg of anileridine.)
Assay preparation— Transfer to a 500-mLvolumetric flask an accurately measured volume of Injection,equivalent to about 100mg of anileridine,dilute with 0.1Nhydrochloric acid to volume,and mix.
Procedure— Transfer 5.0mLeach of the Standard preparation,the Assay preparation,and 0.1Nhydrochloric acid to provide the blank to separate 200-mLvolumetric flasks.To each flask add 25mLof water,5mLof 1Nhydrochloric acid,and 5mLof sodium nitrite solution (1in 1000),and mix.Allow to stand for 2minutes,then add to each flask 5mLof ammonium sulfamate solution (1in 200),and mix.Allow to stand for 3minutes,then add 5mLof N-(1-naphthyl)ethylenediamine dihydrochloride solution (1in 1000),and mix.Allow to stand for 1hour,dilute with water to volume,and mix.Determine the absorbances of the solutions in 1-cm cells at the wavelength of maximum absorbance at about 560nm,with a suitable spectrophotometer,using the reagent blank to set the instrument.Calculate the quantity,in mg,of anileridine (C22H28N2O2)in each mLof the Injection taken by the formula:
(352.48/425.40)(0.5C/V)(AU/AS),
in which 352.48and 425.40are the molecular weights of anileridine and anileridine hydrochloride,respectively;Cis the concentration,in µg per mL,of USP Anileridine Hydrochloride RSin the Standard preparation;Vis the volume,in mL,of Injection taken;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 159
Phone Number:1-301-816-8139