Meperidine Hydrochloride Injection
» Meperidine Hydrochloride Injection is a sterile solution of Meperidine Hydrochloride in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of C15H21NO2·HCl.
Packaging and storage Preserve in single-dose or in multiple-dose containers, preferably of Type I glass.
USP Reference standards 11
USP Endotoxin RS
A: It meets the requirements under IdentificationOrganic 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.
Bacterial endotoxins 85 It contains not more than 2.4 USP Endotoxin Units per mg of meperidine hydrochloride.
pH 791: between 3.5 and 6.0.
Other requirements It meets the requirements under Injections 1.
Buffer solution , Mobile phase, Chromatographic system, and Standard preparationProceed 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:
2500CrU / rSin 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.
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USP35NF30 Page 3802