Meperidine Hydrochloride Injection
»Meperidine Hydrochloride Injection is a sterile solution of Meperidine Hydrochloride in Water for Injection.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of C15H21NO2·HCl.
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass.
Identification—
A: It meets the requirements under Identification—Organic Nitrogenous Bases á181ñ.
B: The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that obtained from the Standard preparationobtained in the Assay.
Bacterial endotoxins á85ñ— It contains not more than 2.4USP Endotoxin Units per mg of meperidine hydrochloride.
pHá791ñ: between 3.5and 6.0.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Buffer solution ,Mobile phase,Chromatographic system,and Standard preparation—Proceed as directed in the Assayunder Meperidine Hydrochloride.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 300mg to a 100-mLvolumetric flask,dilute with water to volume,and mix.Transfer 1.0mLof this solution to a 25-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.
Procedure— Separately inject equal volumes (about 20µL)of the Standard preparationand the Assay preparationinto 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/rS,
in which Cis the concentration,in mg per mL,of USP Meperidine Hydrochloride RSin the Standard preparation,and rUand rSare the meperidine peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Daniel K.Bempong,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 1208
Phone Number:1-301-816-8143
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