Lidocaine Hydrochloride Jelly

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

Lidocaine Hydrochloride Jelly is Lidocaine Hydrochloride in a suitable, water-soluble, sterile, viscous base. It contains NLT 95.0% and NMT 105.0% of the labeled amount of lidocaine hydrochloride

(C₁₄H₂₂N₂O · HCl).

2 IDENTIFICATION

Change to read:

A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K (CN 1-May-2020)

Standard: Prepare as directed in Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K (CN 1-May-2020) , using USP Lidocaine RS.

Sample: Place in a separator containing 10–15 mL of water a quantity of Jelly, equivalent to 300 mg of lidocaine hydrochloride. Mix to assure thorough dilution of the Jelly, and add 4 mL of 6 N ammonium hydroxide. Extract with four 15-mL portions of chloroform. Combine the chloroform extracts, and evaporate with the aid of a current of warm air to dryness. Redissolve the crystals in solvent hexane, evaporate with the aid of warm air, and dry the residue in vacuum over silica gel for 24 h.

Acceptance criteria: The residue so obtained 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

Solution A: 0.1% phosphoric acid, prepared by adding 1.0 mL of 85% phosphoric acid to 1 L of water

Solution B: Acetonitrile

Mobile phase: See Table 1.

Table 1

Diluent: Acetonitrile and Solution A (1:1)

System suitability solution: 0.1 mg/mL of USP Lidocaine RS and 0.04 mg/mL of USP Ropivacaine Related Compound A RS in Diluent

[Note—USP Ropivacaine Related Compound A RS is 2,6-dimethylaniline hydrochloride.]

Standard solution: 0.1 mg/mL of USP Lidocaine RS in Diluent

Sample solution: Nominally 0.12 mg/mL of lidocaine hydrochloride in Diluent from a portion of Jelly. Sonicate the solution for about 10 min.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 210 nm

Column: 4.6-mm × 15-cm; 5-μm packing L1

Flow rate: 0.8 mL/min

Injection volume: 5 μL

System suitability

Samples: System suitability solution and Standard solution

[Note—The relative retention times of 2,6-dimethylaniline and lidocaine are about 0.93 and 1.0, respectively.]

Suitability requirements

Tailing factor: NMT 1.5 for the lidocaine peak, System suitability solution

Relative standard deviation: NMT 2.0%, Standard solution

Resolution: NLT 1.8 between lidocaine and 2,6-dimethylaniline, System suitability solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of lidocaine hydrochloride (C₁₄H₂₂N₂O · HCl) in the portion of Jelly taken:

Result = (r_U/r_S) × (C_S/C_U) × (M_r1/M_r2) × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

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

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

M_r1 = molecular weight of lidocaine hydrochloride, 270.80

M_r2 = molecular weight of lidocaine, 234.34

Acceptance criteria: 95.0%–105.0%

4 PERFORMANCE TESTS

Minimum Fill 〈755〉: Meets the requirements

5 SPECIFIC TESTS

pH 〈791〉: 6.0–7.0

Sterility Tests 〈71〉: Meets the requirements

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers, and store at controlled room temperature.

USP Reference Standards 〈11〉

USP Lidocaine RS

USP Ropivacaine Related Compound A RS

2,6-Dimethylaniline hydrochloride.

C₈H₁₂ClN 157.64