284 Amoxicillin / Official Monographs Acceptance criteria: 90.0%-110.0% PERFORMANCE TESTS « Disinrecearion (701) ‘Medium: ‘Water at 205° Time! 3 min Acceptance criteria: Meet the requirements + Dissouumion (711) Medium: Water; 900 mL Apparatus 2:75 rpm Butler: "27°29 of monobasie pt hosphate i fer: of monobasic potassium phosphate in 3 L of water. Agjust with » 459% (w/w) solution of po- tassium hydroxide to.a pH of 5.0.2 0.1, and dilate with water to obtain 4 L of solution, Mobile phase: Acetonitrile and Buffer (10:390). Pass ‘through fiter of 0am or finer pore size. Standard solution: 0.05 mg/ml of USP Amoxiclin RS in buffer. Use this solution within 6 h Sample solution: Pass a portion af the sample through Biter of O Sum or finer pore size, Dilute a sukable aliquot of the filtrate with water to oblain a concentra- {ion of 0.045 mg/mL of amoxieilin. Use this solution se apts Chromatographic system (Gee Chromatography (621), System Suitabity.) Mode: LC Detector: Uv 230 nm Columns “Guard: 2mm x 2m packing 12 Analytical: "3.9-mm x 30-cm, pac Column temperature: 401° Flow rate: 6.7 mL/min Injection volume: 10 pL system suttability Jample: Standard solution Sultability requirements ‘Capacity factor: 11-28 Column effciency:’ NIT 1700 theoretical plates Trailing factor: NT 2. Relative standard deviation: NMT 1.5% Analysis Samples: Standord sofation and Sample sottion Caletlate the percentage of the labeled amount of ‘amoxciin (CisHsNsO35) dissolved: Result = (rufn) x Cox Vx Dx Px Fx (1/0) x 100 peak response from the Sample solution ppeak response from the Standard solution = Concentration of USP Amoxiciin RS in the Standard souton (ng/ml) V = volume of medium, 960 mi D lution factor P —& potency of amoxicilin in USP Amoxicilin RS ‘g/ma) conversion factor, 0.001 mg/ug inbel clam, (g/l) Tolerances: NLT BOM (Q) ofthe labeled amount of amoxicillin (CisHisNsOsS) is dissolved. © UNiFonmity OF DOSAGE UNITS (905): Meet the requirements SPECIFIC TESTS ® DISPERSION FINENESS: Place 2 Tablets for Oral Suspension ‘in 100 mL. of water, and stir until completely dispersed, smooth dispersion that passes through a No. 25 sieve is obtained. > usp 41 ADDITIONAL REQUIREMENTS. * PACKAGING AND STORAGE: Preserve in tight containers © USP REFERENCE STANDARDS (11) USP Amoxicillin RS Amoxicillin and Clavulanate Potassium for Oral Suspension DEFINITION ‘Amoxicilin and Clavulanate Potassium for Oral Suspension Contains the equivalent of NLT 90.0% and NM 120.0% of the labeled amount of amoxiclin (Gi4HyyNsOsS) and the equivalent of NUT 90.0% and NMT'125.0%6 of the labeled amount of clavulanic acid (CsHsNO;). It contains fone or more suitable buffers, colors, flavors, preservatives, stabilizers, sweeteners, and suspending agents. IDENTIFICATION +/A._ The retention times ofthe major peal of the Sample Solution correspond to those of the Standard solution, as ‘obtained in the Assay. ASSAY ‘© PROCEDURE Buffer: 7.8.9 of monobasic sodium phosphate in '900 ml of water. Adjust with phosphoric acid or 10N sodium hydroxide toa pH of 4.4 + 0.1, and dilute with ‘water to 1000 mi. Mobile phase: Methanol and Buffer (1:19). Pass through a suitable fiter. Standard solution: "0.5 mg/ml of USP Amoxicilin RS ‘and 0.2 mg/ml of USP Clavulanate Lithium RS in water Sample solution: Nominally 0.5 mg/mL of amoxicilin in water, prepared as follows. Constitute Amoxicilin and Ciavulanate Potassium for Oral Suspension with ‘water using the volume specified in the labeling, Stir by mechanical means for min, and fier. Use within 1 Chromatographic system (See, Chromatography (621), System Suitability.) Mode: “LC Detector: UV 220 nm Column: 4-mm x 30-cm; 3- to 101m packing L1 Flow rate: 2 mL/min Injection volume: 20 ul. System suitability imple: Standard solution INotE—The relative retention times for clavulanic acid and amoxicilin are about 0.5 and 1.0, respectively.) Suitability requirements Resolution: 'NLT 3.5 between the am clavulanic acid peaks lin and Taling factor” R13 for each ana peak Relate standard deviation: NNT 0% foreach ‘sralyte peak Analyst ‘Samples: Standard solution and Sample solution Geledlate the percentage of the labeled amount of amoxicillin (CyeHisNaOS) in the Amoxicilin and Clavu- lanate Potassium for Oral Suspension taken: Result = (rut) x (CofGi) x P x Fx 100 tv = Pa response of amoxil fom the Sample soliton r= peak response of amoxiciin from the Standard solton = concentration of USP Amoxiclin RS in the Standard solaton (mg/ml) jinal concentrasor of amoxiilin in the Sample solution (gir) wusp 41 P= potency of amoxicilin in USP Amoxictitin RS ugima) = conversion factor, 0.001 maja Caleulate the percentage of the Iebeled amount of lavulanic acl (GHsNOs) in the Amoxicilin and Clavulanate Potassium for Oral Suspension taken: Result = (n/n) « (GG) x Px 100 ty = peak response of clavulanic acid from the Sample station t= peak response of clavulanic acid from the ‘Standard solution G —=concentration of USP Clavulanate Lithium RS In the Standard solution (mg/ml) y= gia caper of ctare ai in re Sorpl soution (rim P= potency of clavulanic ae In USP Clavulanate Lithium RS (ma/ma) ‘Acceptance criteria: 90.09%6-120.0% of the labeled arnaunt of amoxilin (GHiuNsOs8) and '90.08-125.006 of the labeled amount of clavulanic acid (CaHNOs) PERFORMANCE TESTS ‘© DELIVERABLE VOLUME (698) For powder packaged in multiple-unit containers: Meets the requirements ‘= Uuironmary oF Dosace Unrrs (905) For powder packaged in single-unit containers: Meets the requirements SPECIFIC TESTS = PH (791) Sample solution: Constitute as directed in the labeling, ‘and perform the test immediately after constitution, Acceptance criteria: 3.8-6.6 ‘» MICROBIAL ENUMERATION TESTS (61) and Tests FoR Speci. ‘ep Mictooncansis (62) The total aerobic microbial count does not exceed 103 cfufg, and the total com- bined molds and yeasts count does not exceed 10" cfuf 3 ADDITIONAL REQUIREMENTS ‘© PACKAGING AND STORAGE: Preserve in tight containers, at ‘controlled room temperature. ‘© USP REFERENCE STANDARDS (11) USP Amoxicillin RS USP Clavulanate Lithium RS Amoxicillin and Clavulanate Potassium Tablets DEFINITION Amoxicilin and Clavulanate Potassium Tablets contain the ‘equivalent of NLT 90.0% and NMT 120.0% of the labeled amounts of amoxicillin (CydHiyNsOsS) and clavulanic acid IDENTIFICATION. «The retention times of the major peaks of the Sample solu- tion correspond to those of te Standard solution, as ob- tained in the Assay. ASSAY * PROCEDURE Buffer: 7,89 of monobasic soclum phosphate in ‘900 mL of water. Adjust with phosphonic acid or 10 N sodium hydroxide to a pH of 4.4 = 0.1, and dilute with water to 1000 mL. Mobile phase: Methanol and Buffer (1:19). Pass through a suitable fiter. Official Monographs / Amoxicilin, 285 ‘and 0.2 mg/ml of USP Clavulanate Lithium RS in water suitable volumetric flask, and dilute with water to ie Sample solution: Dilute a suitable volume of the Sam- Gen te Gee Chetan CEN, Sytem Sutaby.) Mode: LC Raced la 2 Pes 200 2 ws toumpedng Li Flow rate: 2mL/min ee Injection size: 20 ul sniecion so sac pase oes ‘lavulanie acid peaks KIS 15 foreach ana peak Tailing factor: Relative standard devi NMT 2. Analysis ‘Samples: Standard solution and Sample solution Calculate the percentage of CyeHisNhOsS in each Tablet a Result = (tu/ts) x (Cs/Cu) x Px F x 100 wy = peakrespnse of amon Fo te Sample za ipods of amoxil om th « ‘ljons of emo om the P Standard soltion cs =cancentaton USP Amoxin RS nthe ‘Standard solution (mg/mL) ca = nor concerts Sonn nthe So aly P potency of USP Amoxicillin RS (jwa/ma) F onvetsion factor, €.001 maf Galette the percentage’ CHANG ih each Tablet Taken: Result = (ruts) x (Ci/Cy) x P x 100 peak response of clavulanic acid from the Sample solution 5 = peak response of clavulanic acid from the ‘Standard solution x = concentration of USP Clavulanate Lithium RS in the Standard solution (mg/mL) @ jaminal concentration of clavulanic acid in the Sample solution (mg/ml) P= potency of clavulanic acid in USP Clavulanate Lithium RS (mg/mg) Acceptance criteria: 90-0%-120.0% PERFORMANCE TESTS + DISINTEGRATION (701): Tablets labeled for veterinary use ‘only; 30 min, simulated gastric fluid TS being substituted for water in the test + DissowuTion (711) INoTE—Tablets labeled for veterinary use only are ex- tempt from this requirement. Test'1 Medium: Water; 900 mL Apparatus 2:75 som ime; 30 min oF 48 min were the Tablets ae labeled Analysis: Determine the amount of CisHieNOs$ and GINO: dissolved, using the Analysis set forth in the Assay, making any necessary volumetric adjustments, ie o S =