Levocarnitine Tablets
DEFINITION
Levocarnitine Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of levocarnitine (C7H15NO3).
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: Dissolve 1 Tablet in 5 mL of water, filter, and add 5 mL of 1 N hydrochloric acid. Place 2 mL of the filtrate in a test tube and add a few drops of ammonium reineckate TS.
Acceptance criteria: A red-violet precipitate is produced.
ASSAY
• Procedure
Buffer: 0.05 M phosphate buffer, pH 4.5, prepared by dissolving 6.805 g of monobasic potassium phosphate in 1 L of water
Solution A: Acetonitrile and Buffer (65:35). Adjust with phosphoric acid to a pH of 4.7, and mix.
Mobile phase: See Table 1.
Table 1
| Time (min) | Acetonitrile (%) | Solution A (%) | Water (%) |
|---|---|---|---|
| 0 | 100 | 0 | 0 |
| 50 | 100 | 0 | 0 |
| 70 | 65 | 0 | 35 |
| 170 | 65 | 0 | 35 |
| 190 | 0 | 100 | 0 |
| 370 | 0 | 100 | 0 |
System suitability solution: 1.5 mg/mL of USP Levocarnitine RS and 7 µg/mL of USP Levocarnitine Related Compound A RS in water
Standard solution: 3 mg/mL of USP Levocarnitine RS in water
Sample solution: Transfer 10 Tablets, accurately weighed, to a 500-mL volumetric flask, and add water to volume. Shake until the Tablets have disintegrated completely, and pass through a filter of 0.45-µm pore size. Dilute a portion of the filtrate quantitatively with water to a nominal concentration of about 3 mg/mL of levocarnitine.
Chromatographic system
(See Chromatography 
621
, System Suitability.)
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 size: 20 µL
System suitability
Samples: System suitability solution and Standard solution
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
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of levocarnitine (C7H15NO3) in the portion of Tablets taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak area of levocarnitine from the Sample solution |
| rS | = | = peak area of levocarnitine from the Standard solution |
| CS | = | = concentration of USP Levocarnitine RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of levocarnitine in the Sample solution (mg/mL) |
Acceptance criteria: 90.0%–110.0%
PERFORMANCE TESTS
• Dissolution 711
711 Medium: Water; 900 mL
Apparatus 2: 75 rpm
Time: 30 min
Standard solution: Known concentration of USP Levocarnitine RS in Medium
Sample solution: Filtered portion of the solution under test, suitably diluted with Medium if necessary
Analysis
Samples: Standard solution and Sample solution
Proceed as directed in the Assay, making any necessary modifications.
Determine the percentage of the labeled amount of levocarnitine (C7H15NO3) dissolved:
Result = (rU/rS) × (CS × D × V/L) × 100
| rU | = | = peak area of levocarnitine in the Sample solution |
| rS | = | = peak area of levocarnitine in the Standard solution |
| CS | = | = concentration of USP Levocarnitine RS in the Standard solution (mg/mL) |
| V | = | = volume of Medium, 900 mL |
| D | = | = dilution factor for Sample solution |
| L | = | = label claim (mg/Tablet) |
Tolerances: NLT 75% (Q) of the labeled amount of levocarnitine (C7H15NO3) is dissolved.
• Uniformity of Dosage Units 905: Meet the requirements for Weight Variation
905: Meet the requirements for Weight VariationADDITIONAL REQUIREMENTS
• Packaging and Storage: Preserve in tight containers.
• USP Reference Standards 11
11 USP Levocarnitine RS 
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USP Levocarnitine Related Compound A RS
2-Propen-1-aminium, 3-carboxy-N,N,N-trimethyl-, chloride.
C7H14ClNO2 179.65
2-Propen-1-aminium, 3-carboxy-N,N,N-trimethyl-, chloride.
C7H14ClNO2 179.65
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Natalia Davydova Scientific Liaison 1-301-816-8328 | (DS2010) Monographs - Dietary Supplements |
| 711 | Margareth R.C. Marques, Ph.D. Senior Scientific Liaison 1-301-816-8106 | (GCDF2010) General Chapters - Dosage Forms |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 3667
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 35 or NF 30.