Levocarnitine Oral Solution DEFINITION Levocarnitine Oral Solution is a solution of levocarnitine in water, and it contains suitable antimicrobial agents. It may contain a suitable flavor. It contains 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, both relative to the internal standard, as obtained in the Assay. ASSAY • Procedure Buffer: 0.05 M phosphate buffer, pH 2.4, prepared by mixing 11.5 mL of phosphoric acid, 1900 mL of water, and about 100 mL of 1 N sodium hydroxide Mobile phase: Dissolve 555 mg of sodium 1-heptanesulfonate in 980 mL of Buffer with stirring. Add 20 mL of methanol, and mix. Internal standard solution: 0.02 mg/mL of p-aminobenzoic acid in water Standard solution: Transfer about 10 mg of USP Levocarnitine RS to a 5-mL volumetric flask, add 1.0 mL of the Internal standard solution, and dilute with water to volume. Sample stock solution: Equivalent to 10 mg/mL of levocarnitine in water from an accurately measured volume of Oral Solution Sample solution: Wash a 10-mm × 4-cm disposable column containing 500 mg of packing L1, in order, with two column volumes of methylene chloride, two column volumes of methanol, and three column volumes of water. Pipet 5.0 mL of the Sample stock solution into the washed disposable column, and rinse the column twice with 6.0-mL portions of water. Collect the filtrate and washings in a 25-mL volumetric flask, add 5.0 mL of the Internal standard solution, and dilute with water to volume. Chromatographic system Mode: LC Detector: UV 225 nm Column: 3.9-mm × 30-cm; 10-µm packing L1 Flow rate: 1.5 mL/min Injection size: 40 µL System suitability Sample: Standard solution [NoteThe relative retention times for levocarnitine and p-aminobenzoic acid are 0.56 and 1.0, respectively. ] Suitability requirements Resolution: NLT 1.5 between the levocarnitine and internal standard peaks Relative standard deviation: NMT 2.0% for levocarnitine Analysis Samples: Standard solution and Sample solution Calculate the percentage of the labeled amount of levocarnitine (C7H15NO3) in the portion of Oral Solution taken: Result = (RU/RS) × (CS/CU) × 100
Acceptance criteria: 90.0%110.0% SPECIFIC TESTS • pH 791: 4.06.0 ADDITIONAL REQUIREMENTS • Packaging and Storage: Preserve in tight containers. Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 3667 Chromatographic Column Chromatographic columns text is not derived from, and not part of, USP 35 or NF 30. |