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 Variation
ADDITIONAL 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