Levetiracetam Tablets - uspnf.com

1 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.

2 Sonication may be used to aid with dilute potassium hydroxide to a pH of solution: Nominally mg/mL of levetiracetamMobile phase: Acetonitrile and Buffer (15:85)from NLT 20 Tablets , finely crushed, in Diluent. SonicationStandard solution: (L/1000) mg/mL in Medium, where L ismay be used to aid Tablet label claim, in mgChromatographic systemSample solution: Pass a portion of the solution under test(See Chromatography 621 , System Suitability.)though a suitable filter of pore : LCChromatographic systemDetector: UV 220 nm(See Chromatography 621 , System Suitability.)Column: 25-cm; 4-mm packing L1 Mode: LCFlow rate: 2 mL/minDetector: UV 220 nmInjection size: 10 mLColumn: 15-cm; 5-mm packing L1 System suitabilityFlow rate: mL/minSample: Standard solutionInjection size: 10 mLSuitability requirementsSystem suitabilityTailing factor: NMT : Standard solutionRelative standard deviation: NMT requirementsAnalysisTailing factor: NMT : Standard solution and Sample solutionRelative standard deviation: NMT the percentage of Levetiracetam (C8H14N2O2) in theAnalysisportion of Tablets taken:Samples: Standard solution and Sample solutionDetermine the percentage of Levetiracetam ( C8H14N2O2)Result = (rU/rS) (CS/CU) 100dissolved.

3 RU= peak response from the Sample solutionResult = (rU/rS) (CS/L) V 100rS= peak response from the Standard solutionCS= concentration of USP Levetiracetam RS in therU= peak response from the Sample solutionStandard solution (mg/mL)rS= peak response from the Standard solutionCU= nominal concentration of Levetiracetam in theCS= concentration of USP Levetiracetam RS in theSample solution (mg/mL)Standard solution (mg/mL)L= label claim (mg/Tablet)V= volume of Medium, 900 mLTolerances: NLT 70% (Q) of the labeled amount of leve-tiracetam (C8H14N2O2) in 15 min for Tablets labeled to con-tain 250 mg, or 500 mg, or 750 mg; NLT 80% (Q) of thelabeled amount of Levetiracetam (C8H14N2O2) in 30 min forTablets labeled to contain 1000 mg Test 2: If the product complies with this test, the labelingindicates that the product meets USP Dissolution Test : Water; 900 mL, deaerate, if necessaryApparatus 2: 50 rpmTime: 15 minBuffer: of monobasic potassium phosphate, ad-justed with 10% potassium hydroxide to a pH of phase: Acetonitrile and Buffer (10:90)Standard solution: 54 mg/mL of USP Levetiracetam RS inMedium 2011 The United States Pharmacopeial ConventionAll Rights Bulletin2 LevetiracetamOfficial May 1, 2011 Sample solution: Pass a portion of the solution under testMode: LCthrough a suitable filter.

4 Dilute an aliquot with Medium toDetector: UV 200 nmobtain a concentration similar to that of the StandardColumn: 25-cm; 4-mm packing rate: 1 mL/minChromatographic systemInjection size: 10 mL(See Chromatography 621 , System Suitability.)System suitabilityMode: LCSamples: System suitability solution and Standard solutionDetector: UV 210 nmSuitability requirementsColumn: 15-cm; 5-mm packing L1 Resolution: NLT between Levetiracetam related com-Column temperature: 30 pound B and Levetiracetam , System suitability solutionFlow rate: mL/minTailing factor: NMT , Standard solutionInjection size: 20 mLRelative standard deviation: NMT , StandardSystem suitabilitysolutionSample: Standard solutionAnalysisSuitability requirementsSamples: Standard solution and Sample solutionTailing factor: NMT the percentage of each impurity in the portion ofRelative standard deviation: NMT taken:AnalysisResult = (rU/rS) (CS/CU) (1/F) 100 Samples: Standard solution and Sample solutionDetermine the percentage of Levetiracetam (C8H14N2O2)rU= peak response of each impurity from the Sampledissolved.

5 SolutionrS= peak response of Levetiracetam from the StandardResult = (rU/rS) (CS/L) D V 100solutionrU= peak response from the Sample solutionCS= concentration of USP Levetiracetam RS in therS= peak response from the Standard solutionStandard solution (mg/mL)CS= concentration of USP Levetiracetam RS in theCU= nominal concentration of Levetiracetam in theStandard solution (mg/mL)Sample solution (mg/mL)L= label claim (mg/Tablet)F= relative response factor as listed in Table 2D= dilution factor of the Sample solutionAcceptance criteria See Table volume of Medium, 900 mLTolerances: NLT 80% (Q) of the labeled amount of leve- Table 2tiracetam (C8H14N2O2) is 3: If the product complies with this test, the labelingRetentionResponseCriteria,indica tes that the product meets USP Dissolution Test (%)Medium: Water; 900 mLLevetiracetam relatedApparatus 2: 50 rpmcompound Ba, Time: 30 minBuffer, Mobile phase, Standard solution, Sample solution, Chromatographic system, System suitability, and Analy- Levetiracetam relatedsis: Proceed as directed for Test 1compound Aa, Tolerances: NLT 80% (Q) of the labeled amount of leve- Levetiracetam (C8H14N2O2) is dissolved.

6 (RB 1-May-2011)Any individual un- UNIFORMITY OF DOSAGE UNITS 905 : Meet the requirementsspecified impurity impurities ORGANIC IMPURITIES aThese impurities are listed for information only; they are process impuri-Buffer: of monobasic potassium phosphate andties, which are controlled in the drug of sodium 1-heptanesulfonate, adjusted with phos-b(S) acid to a pH of (S)-N-(1-Amino-1-oxobutan-2-yl) phase: Acetonitrile and Buffer (5:95)d(S)-2-(2-Oxopyrrolidine-1-yl)buta noic suitability solution: mg/mL of USP Leve-ADDITIONAL REQUIREMENTS tiracetam RS and mg/mL of USP Levetiracetam Related PACKAGING AND STORAGE: Preserve in tight containers. StoreCompound B RS in Mobile phaseat controlled room solution: mg/mL USP Levetiracetam RS in Mo-bile phaseSample solution: Equivalent to mg/mL of levetiracetamAdd the following:from NLT 20 Tablets , finely crushed, in Mobile phase.

7 [NOTE Sonicate if necessary, and centrifuge the solution LABELING: When more than one Dissolution test is given,before passing through a suitable filter.]the labeling states the Dissolution test used only if Test 1 is notChromatographic systemused. (RB 1-May-2011)(See Chromatography 621 , System Suitability.) USP REFERENCE STANDARDS 11 USP Levetiracetam RSUSP Levetiracetam Related Compound B RS(S) 2011 The United States Pharmacopeial ConventionAll Rights Reserved.