3666 newp0rt1于2011年11月25星期五.pdfVIP

USP 35 Official Monographs / Levocarnitine 3665 sum of all peak areas in the Sample solution, except for the Acceptance criteria: 97.0%–103.0% on the anhydrous basis major peak, is not greater than twice the major peak area of the Standard solution (1.0%). IMPURITIES • RESIDUE ON IGNITION 281: NMT 0.5% SPECIFIC TESTS • CHLORIDE AND SULFATE, Chloride 221 • OPTICAL ROTATION, Specific Rotation 781S: –102 to −106 Standard: 0.50 mL of 0.020 N hydrochloric acid at 20 Sample: 0.090 g of Levocarnitine Sample solution: 10 mg/mL in methanol Acceptance criteria: NMT 0.4% • LOSS ON DRYING 731: Dry about 1.000 g of the sample at • HEAVY METALS 231: NMT 20 ppm 105 to constant weight: it loses NMT 0.5% of its weight. • LIMIT OF POTASSIUM [NOTE—The Standard solution and the Sample solutions may ADDITIONAL REQUIREMENTS be modified, if necessary, to obtain solutions of suitable • PACKAGING AND STORAGE : Preserve in well-closed containers. concentrations adaptable to the linear or working range of Protect from light. the instrument.] • USP REFERENCE STANDARDS  11 Standard solution: 31.25 g/mL of potassium in water, USP Levocabastine Hydrochlori