Meperidine Hydrochloride

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 contains NLT 98.0% and NMT 102.0% of meperidine hydrochloride (C₁₅H₂₁NO₂ · HCl), calculated on the dried basis.

2 IDENTIFICATION

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

B. Identification Tests—General, Chloride〈191〉

Sample solution: 10 mg/mL

Acceptance criteria: Meets the requirements

C. 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

Solution A: 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 Solution A (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: 0.6 mg/mL of Meperidine Hydrochloride in water

Sample solution: 0.12 mg/mL of Meperidine Hydrochloride from the Sample stock solution in Mobile phase

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 for the meperidine peak

Relative standard deviation: NMT 2%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of meperidine hydrochloride (C₁₅H₂₁NO₂ · HCl) in the portion of Meperidine Hydrochloride taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of meperidine from the Sample solution

r_S = peak response of meperidine from the Standard solution

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

C_U = concentration of Meperidine Hydrochloride in the Sample solution (mg/mL)

Acceptance criteria: 98.0%–102.0% on the dried basis

4 OTHER COMPONENTS

Content of Chloride

Sample solution: Transfer about 500 mg of Meperidine Hydrochloride, previously dried, to a 250-mL conical flask. Add 15 mL of water, 5 mL of glacial acetic acid, 50 mL of methanol, and 0.2 mL of eosin Y TS.

Analysis: Titrate the Sample solution with 0.1 N silver nitrate VS to a rose-colored endpoint. Each mL of 0.1 N silver nitrate is equivalent to 3.545 mg of chloride.

Acceptance criteria: 12.2%–12.7% of chloride is found.

5 IMPURITIES

Residue on Ignition 〈281〉: NMT 0.1%

Organic Impurities

Sample solution: 10 mg/mL in water

Chromatographic system

Mode: GC

Detector: Flame ionization

Column: 2-mm × 2-m glass; 10% phase G3 on support S1A

Temperatures

Column: 190°

Injection port: 255°

Detector: 280°

Carrier gas: Helium

Flow rate: 28 mL/min

Injection volume: 2.0 μL

Analysis

Sample: Sample solution

Calculate the area percentage of each peak.

Acceptance criteria: No peak other than the principal peak (except for the solvent peak) constitutes more than 1.0% of the total area.

6 SPECIFIC TESTS

Loss on Drying 〈731〉

Analysis: Dry under vacuum at a pressure between 20 and 40 mm of mercury at 80° for 4 h.

Acceptance criteria: NMT 1.0%

Melting Range or Temperature 〈741〉

Sample: Dried under vacuum at 80° for 4 h

Acceptance criteria: 186°–189°

7 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed, light-resistant containers, and store at room temperature.

USP Reference Standards 〈11〉

USP Meperidine Hydrochloride RS