Transcription of Levetiracetam Tablets - uspnf.com
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Levetiracetam Tablets - uspnf.com
Revision BulletinOfficial May 1, 2011 Levetiracetam1 Acceptance criteria: the following:.PERFORMANCE TESTSsLevetiracetam TabletsChange to read:DEFINITIONL evetiracetam Tablets contain NLT and NMT of Dissolution 711 the labeled amount of Levetiracetam (C8H14N2O2). Test 1 (RB 1-May-2011)Medium: Water; 900 mLIDENTIFICATIONA pparatus 2: 50 rpm A. INFRARED ABSORPTION 197K Time: See Table 1. B. The retention time of the major peak of the Sample solu-tion corresponds to that of the Standard solution, as obtainedin the 1 Tablet StrengthTimeASSAY(mg/Tablet)(min) PROCEDUREB uffer: of monobasic potassium phosphate of sodium 1-heptanesulfonate, adjusted with phos-50015phoric acid to a pH of phase: Acetonitrile and Buffer (8:92)100030 Diluent: Acetonitrile and water (20:80)Standard solution: mg/mL of USP Levetiracetam RS inBuffer: of monobasic potassium phosphate, ad-Diluent.
Revision Bulletin 2 Levetiracetam Official May 1, 2011 Sample solution: Pass a portion of the solution under test Mode: LC through a suitable filter. Dilute an aliquot with Medium to Detector: UV 200 nm obtain a concentration similar to that of the Standard Column: 4.6-mm × 25-cm; 4-µm packing L1 solution.
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