Levocarnitine Injection

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

DOWNLOAD PDF HERE

1 DEFINITION

Levocarnitine Injection is a sterile solution of Levocarnitine in Water for Injection. It contains NLT 90.0% and NMT 110.0% of the labeled amount of levocarnitine (C₇H₁₅NO₃ ).

2 IDENTIFICATION

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

B. Color Reaction

Analysis: Transfer 2 mL of Injection to a test tube, add 5 mL of 1 N hydrochloric acid and a few drops of ammonium reineckate TS.

Acceptance criteria: A red-violet precipitate is produced.

3 ASSAY

3.1 Procedure

Buffer: 0.05 M phosphate buffer, prepared by dissolving 6.805 g of monobasic potassium phosphate in 1 L of water

Mobile phase: Acetonitrile and Buffer (65:35). Adjust with phosphoric acid to a pH of 4.7, and mix.

System suitability solution: 5 mg/mL of USP Levocarnitine RS and 0.024 mg/mL of USP Levocarnitine Related Compound A RS in water

Standard solution: 10 mg/mL of USP Levocarnitine RS in water

Sample solution: Pool the contents of 10 containers, and dilute an accurately measured volume of Injection quantitatively with water to obtain a solution having a nominal concentration of about 10 mg/mL of levocarnitine.

3.2 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 205 nm

Column: 3.9-mm × 30-cm; 10-μm packing L8

Flow rate: 1 mL/min

Injection volume: 5 μL

3.3 System suitability

Samples: System suitability solution and Standard solution

3.4 Suitability requirements

Resolution: NLT 1.0 between levocarnitine related compound A (crotonoylbetaine) and levocarnitine, System suitability solution

Relative standard deviation: NMT 2.0% for levocarnitine, Standard solution

3.5 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of levocarnitine (C₇H₁₅NO₃ ) in the portion of Injection taken:

Result = (r_U/r_S)x(C_S/C_U) × 100

r_U = peak area of levocarnitine from the Sample solution

r_S = peak area of levocarnitine from the Standard solution

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

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

Acceptance criteria: 90.0%–110.0%

4 SPECIFIC TESTS

Bacterial Endotoxins Test 〈85〉 : It contains NMT 0.1 USP Endotoxin Units/mg of levocarnitine.

pH 〈791〉: 6.0–6.5

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

Injections and Implanted Drug Products 〈1〉: Meets the requirements

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in single-dose containers, preferably of Type I glass. Store below 25°. Do not freeze.

USP Reference Standards 〈11〉

USP Levocarnitine RS

USP Levocarnitine Related Compound A RS

2-Propen-1-aminium, 3-carboxy-N,N,N-trimethyl-, chloride.

C₇H₁₄ClNO₂ 179.65