Meperidine Hydrochloride Oral Solution

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Meperidine Hydrochloride Oral Solution contains NLT 95.0% and NMT 105.0% of the labeled amount of meperidine hydrochloride (C₁₅H₂₁NO₂ · HCl).

2 IDENTIFICATION

A.

Sample solution: Transfer a volume of Oral Solution nominally 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.

Standard solution: Prepare in a way similar to that for the Sample solution, using USP Meperidine Hydrochloride RS.

Acceptance criteria: The UV absorption spectrum of the Sample solution exhibits maxima and minima at the same wavelengths as those of the Standard solution.

3 ASSAY

Procedure

Sample solution: Transfer a suitable volume of Oral Solution nominally 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.

Analysis: 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 (C H NO · HCl).

Acceptance criteria: 95.0%–105.0%

4 PERFORMANCE TESTS

Deliverable Volume 〈698〉: Meets the requirements for oral solution packaged in multiple-unit containers

Uniformity of Dosage Units 〈905〉: Meets the requirements for oral solution packaged in single-unit containers

5 SPECIFIC TESTS

pH 〈791〉: 3.5–4.1

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight, light-resistant containers.

USP Reference Standards 〈11〉

USP Meperidine Hydrochloride RS