Lacosamide 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

Lacosamide Injection is a sterile solution of Lacosamide in Water for Injection. It contains NLT 90.0% and NMT 105.0% of the labeled amount of lacosamide (C₁₃H₁₈N₂O₃). It contains no antimicrobial agents.

2 IDENTIFICATION

A. The UV spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

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

Mobile phase: Acetonitrile and water (13:87). To each liter add 0.75 mL of methanesulfonic acid.

Diluent: Acetonitrile and water (13:87)

System suitability solution: 1 mg/mL of USP Lacosamide RS and 2 μg/mL each of USP Lacosamide Related Compound D RS and USP

Lacosamide Related Compound F RS in Diluent

Standard solution: 1 mg/mL of USP Lacosamide RS in Diluent

Sample solution: Nominally 1 mg/mL of lacosamide from Injection prepared as follows. Transfer an appropriate volume of Injection to a suitable volumetric flask, and dilute with Diluent to volume.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 215 nm. For Identi

cation A, use a diode array detector in the range of 230–300 nm.

Column: 4.6-mm × 15-cm; 5-μm packing L7

Temperatures

Autosampler: 10°

Column: 35°

Flow rate: 2 mL/min

Injection volume: 5 μL

Run time: NLT 2.5 times the retention time of lacosamide

System suitability

Samples: System suitability solution and Standard solution

[Note—The relative retention times for lacosamide related compound D, lacosamide related compound F, and lacosamide are 0.38, 0.48, and 1.0, respectively.]

Suitability requirements

Resolution: NLT 1.5 between lacosamide related compound D and lacosamide related compound F, System suitability solution

Tailing factor: NMT 1.5, Standard solution

Relative standard deviation: NMT 1.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of lacosamide (C₁₃H₁₈N₂O₃) in the portion of Injection taken:

Result = (r_U/r_S)x(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 Lacosamide RS in the Standard solution (mg/mL)

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

Acceptance criteria: 90.0%–105.0%

4 IMPURITIES

Organic Impurities

Mobile phase, Diluent, System suitability solution, Sample solution, and Chromatographic system: Proceed as directed in the Assay.

Sensitivity solution: 0.001 mg/mL of USP Lacosamide RS in Diluent

Standard solution: 0.002 mg/mL of USP Lacosamide RS in Diluent

System suitability

Samples: System suitability solution, Sensitivity solution, and Standard solution

[Note—The relative retention times for lacosamide related compound D, lacosamide related compound F, and lacosamide are 0.38, 0.48, and 1.0, respectively.]

Suitability requirements

Resolution: NLT 1.5 between lacosamide related compound D and lacosamide related compound F, System suitability solution

Relative standard deviation: NMT 5.0%, Standard solution

Signal-to-noise ratio: NLT 10, Sensitivity solution

Analysis

Samples: Sample solution and Standard solution

Calculate the percentage of each degradation product in the portion of Injection taken:

Result = (r_U/r_S)x(C_S/C_U) × 100

r_U = peak response of each degradation product from the Sample solution

r_S = peak response of lacosamide from the Standard solution

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

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

Acceptance criteria: The reporting threshold is 0.10%.

Lacosamide related compound D: NMT 0.80%

Any individual unspecified degradation product: NMT 0.20%

Total degradation products: NMT 2.0%

5 SPECIFIC TESTS

pH 〈791〉: 3.8–5.0

Particulate Matter in Injections 〈788〉: Meets the requirements for small-volume injections

Sterility Tests 〈71〉: Meets the requirements

Bacterial Endotoxins Test 〈85〉: Meets the requirements

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed Type 1 glass vials. Store at controlled room temperature.

USP Reference Standards 〈11〉

USP Lacosamide RS

USP Lacosamide Related Compound D RS

2-Amino-N-benzyl-3-methoxypropanamide oxalate.

C₁₁H₁₆N₂O₂ · C₂H₂O₄ 298.30

USP Lacosamide Related Compound F RS

2-Acetamido-N-benzyl-3-hydroxypropanamide.

C₁₂H₁₆N₂O₃ 236.27 (USP 1-May-2021)