Meperidine Hydrochloride Injection

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 Injection is a sterile solution of Meperidine Hydrochloride in Water for Injection. It contains NLT 95.0% and NMT 105.0% of the labeled amount of meperidine hydrochloride (C₁₅H₂₁NO₂ · HCl).

2 IDENTIFICATION

A. Identification—Organic Nitrogenous Bases 〈181〉: Meets the requirements

B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

Procedure

Buffer: Transfer about 6.8 g of monobasic potassium phosphate to a 1000-mL volumetric flask. Dissolve in and dilute with water to volume.

Add 10 mL of triethylamine, and mix. Adjust with phosphoric acid to a pH of 7.0, and filter.

Mobile phase: Acetonitrile and Buffer (550:450), filtered and degassed

Standard stock solution: 0.6 mg/mL of USP Meperidine Hydrochloride RS in water

Standard solution: 0.12 mg/mL of USP Meperidine Hydrochloride RS from the Standard stock solution in Mobile phase

Sample stock solution: Transfer a measured volume of Injection equivalent to about 300 mg to a 100-mL volumetric flask, and dilute with water to volume.

Sample solution: Transfer 1.0 mL of the Sample stock solution to a 25-mL volumetric flask, dilute with Mobile phase to volume, and mix.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 230 nm

Column: 3.9-mm × 30-cm; packing L1

Flow rate: 1 mL/min

Injection volume: 20 μL

System suitability

Sample: Standard solution

Suitability requirements

Column efficiency: NLT 2000 theoretical plates

Tailing factor: NMT 2

Relative standard deviation: NMT 2%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of meperidine hydrochloride (C₁₅H₂₁NO₂ · HCl) in the portion of Injection taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Meperidine Hydrochloride RS in the Standard solution (mg/mL)

C_U = nominal concentration of meperidine hydrochloride in the Sample solution (mg/mL)

Acceptance criteria: 95.0%–105.0%

4 SPECIFIC TESTS

pH 〈791〉: 3.5–6.0

Bacterial Endotoxins Test 〈85〉: It contains NMT 2.4 USP Endotoxin Units/mg of meperidine hydrochloride.

Other Requirements: It meets the requirements in Injections and Implanted Drug Products 〈1〉.

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in single-dose or multiple-dose containers, preferably of Type I glass.

USP Reference Standards 〈11〉

USP Meperidine Hydrochloride RS