Meperidine Hydrochloride Oral Solution
» Meperidine Hydrochloride Oral Solution contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of meperidine hydrochloride (C15H21NO2·HCl).
Packaging and storage— Preserve in tight, light-resistant containers.
Identification— Transfer a volume of Oral Solution, equivalent to about 100 mg of meperidine hydrochloride, to a 125-mL separator, add 40 mL of water and 3 mL of 1 N sodium hydroxide, and extract with three 25-mL portions of n-hexane. Wash the combined extracts with two 20-mL portions of water, discard the water, and then extract with three 25-mL portions of 0.1 N hydrochloric acid. Transfer the extracts to a 100-mL volumetric flask, dilute with 0.1 N hydrochloric acid to volume, and mix: the UV absorption spectrum of this solution exhibits maxima and minima at the same wavelengths as that of a similar preparation of USP Meperidine Hydrochloride RS, concomitantly measured.
Uniformity of dosage units 905
for oral solution packaged in single-unit containers: meets the requirements.
Deliverable volume 698
for oral solution packaged in multiple-unit containers: meets the requirements.
pH 791: between 3.5 and 4.1.
Assay— Transfer an accurately measured volume of Oral Solution, equivalent to about 250 mg of meperidine hydrochloride, to a separator, and add 3 mL of 1 N sodium hydroxide. Extract with five 20-mL portions of chloroform, and filter the extracts through a pledget of cotton into a 250-mL conical flask. Wash the cotton with 5 mL of chloroform, and add the washing to the combined filtrates. Add 10 mL of glacial acetic acid and 2 drops of crystal violet TS, and titrate with 0.1 N perchloric acid VS to a blue endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 28.38 mg of meperidine hydrochloride (C15H21NO2·HCl).
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Clydewyn M. Anthony, Ph.D.
(MDCCA05) Monograph Development-Cough Cold and Analgesics
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 2882
Pharmacopeial Forum: Volume No. 30(1) Page 129