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.
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Identification—
A:
It meets the requirements under Identification—Organic Nitrogenous Bases 
181
.
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.
85—
It contains not more than 2.4 USP Endotoxin Units per mg of meperidine hydrochloride.
pH 791:
between 3.5 and 6.0.
791:
between 3.5 and 6.0.
Other requirements—
It meets the requirements under Injections 1.
1.
Assay—
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:
2500CrU / rS
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.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Clydewyn M. Anthony, Ph.D.
Senior Scientific Liaison 1-301-816-8139 |
(SM22010) Monographs - Small Molecules 2 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
|
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
USP35–NF30 Page 3802