A: It meets the requirements under Identification—Organic Nitrogenous Bases 181.

B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that obtained from the Standard preparation obtained in the Assay.

(Official January 1, 2007)

Buffer solution , Mobile phase, Chromatographic system, and Standard preparation—Proceed as directed in the Assay under Meperidine Hydrochloride.

Assay preparation— Transfer an accurately measured volume of Injection, equivalent to about 300 mg to a 100-mL volumetric flask, dilute with water to volume, and mix. Transfer 1.0 mL of this solution to a 25-mL volumetric flask, dilute with Mobile phase to volume, and mix.

Procedure— Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the peak responses. Calculate the quantity, in mg, of C15H21NO2·HCl in the volume of Injection taken by the formula: in which C is the concentration, in mg per mL, of USP Meperidine Hydrochloride RS in the Standard preparation, and rU and rS are the meperidine peak responses obtained from the Assay preparation and the Standard preparation, respectively.