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11 USP Monographs - Levofloxacin
11 USP Monographs - Levofloxacin
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370.38
( )-(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine6-carboxylic acid, hemihydrate Anhydrous DEFINITION Levofloxacin contains NLT 98.5% and NMT 102.0% of C18H20FN3O 4, calculated on the anhydrous basis. IDENTIFICATION A. INFRARED ABSORPTION obtained in the Assay. ASSAY PROCEDURE Solution A: 8.5 g/L of ammonium acetate, 1.25 g/L of cupric sulfate, pentahydrate, and 1.3 g/L of L-isoleucine in water Mobile phase: Methanol and Solution A (3:7) Standard solution: 1 mg/mL of USP Levofloxacin RS in Mobile phase Sample solution: 1 mg/mL of Levofloxacin in Mobile phase Chromatographic system (See Chromatography Mode: LC Detector: UV 360 nm Column: 4.6-mm 25-cm; 5-m packing L1 Column temperature: 45 Flow rate: 0.8 mL/min Injection size: 25 L 621 , System Suitability.) 197K [100986-85-41]. [138199-71-0].
B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as
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System suitability Sample: Standard solution Suitability requirements Tailing factor: 0.51.5 Relative standard deviation: NMT 1.0% Analysis Samples: Standard solution and Sample solution Calculate the percentage of C18H20FN3O 4 in the portion of Levofloxacin taken: Result = (r U/rS) (CS/CU) 100
rU rS CS CU
= = peak response of Levofloxacin from the Sample solution = = peak response of levofloxacin from the Standard solution = = concentration of USP Levofloxacin RS in the Standard solution (mg/mL) = = concentration of Levofloxacin in the Sample solution (mg/mL)
Acceptance criteria: 98.5%102.0% on the anhydrous basis IMPURITIES Inorganic Impurities RESIDUE ON IGNITION 281 : NMT 0.2%. Use a platinum crucible. 231 : NMT 10 ppm
Solution A, Mobile phase, Sample solution, and Chromatographic system: Proceed as directed in the Assay. System suitability solution: 1 mg/mL of USP Levofloxacin RS in Mobile phase Sensitivity solution: 0.3 g/mL of USP Levofloxacin RS in Mobile phase System suitability Samples: System suitability solution and Sensitivity solution Suitability requirements Relative standard deviation: NMT 1.0%, System suitability solution Signal-to-noise ratio: NLT 10, Sensitivity solution Analysis Sample: Sample solution Calculate the percentage of each individual impurity in the portion of Levofloxacin taken: Result = (r U/rS) (1/F) 100
rU rS F
= = peak area response of each impurity = = peak area response of levofloxacin = = relative response factor (see Impurity Table 1)
Acceptance criteria Individual impurities: See Impurity Table 1. Total impurities: NMT 0.5%.
[NOTE
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impurities.
Impurity Table 1
Name
Acceptance Criteria, NMT (%) 0.3 0.3 0.3 0.3 0.8 0.1
PACKAGING AND STORAGE : Preserve in tight and light-resistant containers. Store at room temperature. USP REFERENCE STANDARDS USP Levofloxacin RS
USP34
11
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Expert Committee
Pharmacopeial Forum: Volume No. 35(6) Page 1459 Chromatographic Column LEVOFLOXACIN Chromatographic columns text is not derived from, and not part of, USP 34 or NF 29.
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