Mepivacaine 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

Mepivacaine Hydrochloride Injection is a sterile solution of Mepivacaine Hydrochloride in Water for Injection. It contains NLT 95.0% and NMT 105.0% of the labeled amount of mepivacaine hydrochloride (C₁₅H₂₂N₂O · HCl).

2 IDENTIFICATION

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

B.

Analysis: Extract a volume of Injection, equivalent to 200 mg of mepivacaine, with two 10-mL portions of ether, and discard the ether extracts.

Render the remaining solution slightly alkaline with sodium carbonate TS, and extract the precipitate with ether. Evaporate the ether extract on a steam bath to dryness, and dry the residue under vacuum at 60° for 1 h.

Acceptance criteria: The mepivacaine obtained melts between 149° and 153°.

3 ASSAY

Procedure

Buffer: 3.40 g/L of monobasic potassium phosphate and 4.35 g/L of dibasic potassium phosphate in water. Adjust with potassium hydroxide or phosphoric acid to a pH of 6.3.

Mobile phase: Acetonitrile and Buffer (35:65)

System suitability solution: 0.05 mg/mL of methylparaben and 1.0 mg/mL of USP Mepivacaine Hydrochloride RS in Mobile phase

Standard solution: 1.0 mg/mL of USP Mepivacaine Hydrochloride RS in Mobile phase

Sample solution: Nominally 1 mg/mL of mepivacaine hydrochloride from Injection in Mobile phase

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 263 nm

Column: 4.6-mm × 25-cm; 5-μm packing L11

Column temperature: 40°

Flow rate: 1 mL/min

Injection volume: 10 μL

System suitability

Samples: System suitability solution and Standard solution

[Note—The relative retention times for mepivacaine and methylparaben are 1.0 and 1.4, respectively.]

Suitability requirements

Resolution: NLT 2.0 between methylparaben and mepivacaine, System suitability solution

Capacity factor: NLT 1.0 for the mepivacaine peak, System suitability solution

Tailing factor: NMT 2.0 for the mepivacaine peak, System suitability solution

Relative standard deviation: NMT 2.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of mepivacaine hydrochloride (C₁₅H₂₂N₂O · HCl) in the volume 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 Mepivacaine Hydrochloride RS in the Standard solution (mg/mL)

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

Acceptance criteria: 95.0%–105.0%

4 SPECIFIC TESTS

pH 〈791〉: 4.5–6.8

Bacterial Endotoxins Test 〈85〉: It contains NMT 0.8 USP Endotoxin Unit/mg of mepivacaine 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. Injection labeled to contain 2% or less of mepivacaine hydrochloride may be packaged in 50-mL multiple-dose containers.

USP Reference Standards 〈11〉

USP Mepivacaine Hydrochloride RS