» Anileridine Injection is a sterile solution of Anileridine in Water for Injection, prepared with the aid of Phosphoric Acid. It contains not less than 90.0 percent and not more than 115.0 percent of the labeled amount of anileridine (C22H28N2O2), as the phosphate.
Packaging and storage Preserve in single-dose or multiple-dose containers, preferably of Type I glass, protected from light.
A: Dilute a volume of Injection, equivalent to about 1.25 mg of anileridine, with water to 5 mL, and add 2 mL of a 1 in 100 solution of p-dimethylaminobenzaldehyde in alcohol: a yellow color develops immediately.
B: A volume of Injection, diluted with water to a concentration of about 25 mg of anileridine in 1000 mL, exhibits absorbance maxima at 234 ± 1 and 285 ± 2 nm.
Bacterial endotoxins 85 It contains not more than 7.2 USP Endotoxin Units per mg of anileridine.
pH 791: between 4.5 and 5.0.
Other requirements It meets the requirements under Injections 1.
Standard preparation [notePrepare on the day of the assay.] Dissolve an accurately weighed quantity of USP Anileridine Hydrochloride RS in 0.1 N hydrochloric acid, and quantitatively dilute with the same solvent to obtain a solution having a known concentration of about 250 µg per mL. (Each mg of anileridine hydrochloride is equivalent to 0.8286 mg of anileridine.)
Assay preparation Transfer to a 500-mL volumetric flask an accurately measured volume of Injection, equivalent to about 100 mg of anileridine, dilute with 0.1 N hydrochloric acid to volume, and mix.
Procedure Transfer 5.0 mL each of the Standard preparation, the Assay preparation, and 0.1 N hydrochloric acid to provide the blank to separate 200-mL volumetric flasks. To each flask add 25 mL of water, 5 mL of 1 N hydrochloric acid, and 5 mL of sodium nitrite solution (1 in 1000), and mix. Allow to stand for 2 minutes, then add to each flask 5 mL of ammonium sulfamate solution (1 in 200), and mix. Allow to stand for 3 minutes, then add 5 mL of N-(1-naphthyl)ethylenediamine dihydrochloride solution (1 in 1000), and mix. Allow to stand for 1 hour, 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 560 nm, with a suitable spectrophotometer, using the reagent blank to set the instrument. Calculate the quantity, in mg, of anileridine (C22H28N2O2) in each mL of the Injection taken by the formula:
(352.48 / 425.40)(0.5C / V)(AU / AS)in which 352.48 and 425.40 are the molecular weights of anileridine and anileridine hydrochloride, respectively; C is the concentration, in µg per mL, of USP Anileridine Hydrochloride RS in the Standard preparation; V is the volume, in mL, of Injection taken; and AU and AS are the absorbances of the solutions from the Assay preparation and the Standard preparation, respectively.
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USP32NF27 Page 1558