Amoxicillin and Clavulanate Potassium Tablets
»Amoxicillin and Clavulanate Potassium Tablets contain the equivalent of not less than 90.0percent and not more than 120.0percent of the labeled amounts of amoxicillin (C16H19N3O5S)and clavulanic acid (C8H9NO5).
Packaging and storage— Preserve in tight containers.
Labeling— Label chewable Tablets to include the word “chewable”in juxtaposition to the official name.The labeling indicates that chewable Tablets may be chewed before being swallowed or may be swallowed whole.Tablets intended for veterinary use only are so labeled.
Identification— The retention times of the major peaks in the chromatogram of the Assay preparationcorrespond to those in the chromatogram of the Standard preparation,as obtained in the Assay.
Disintegration á701ñ: Tablets labeled for veterinary use only;30minutes,simulated gastric fluid TSbeing substituted for water in the test.
Dissolution á711ñ— [NOTE—Tablets labeled for veterinary use only are exempt from this requirement.]
Medium: water;900mL.
Apparatus 2: 75rpm.
Time: 30minutes;or 45minutes where the Tablets are labeled as chewable.
Procedure— Determine the amount of amoxicillin (C16H19N3O5S)and clavulanic acid (C8H9NO5)dissolved,employing the procedure set forth in the Assay,making any necessary volumetric adjustments.
Tolerances— Not less than 85%(Q)of the labeled amount of C16H19N3O5Sand not less than 80%(Q)of the labeled amount of C8H9NO5are dissolved in 30minutes.
FOR TABLETS LABELED AS CHEWABLE— Not less than 80%(Q)of the labeled amounts of C16H19N3O5Sand C8H9NO5is dissolved in 45minutes.
Uniformity of dosage units á905ñ: meet the requirements for Weight Variationwith respect to amoxicillin and for Content Uniformitywith respect to clavulanic acid.
Water,Method Iá921ñ: not more than 7.5%where the labeled amount of amoxicillin in each Tablet is 250mg or less;not more than 10.0%where the labeled amount of amoxicillin in each Tablet is more than 250mg but less than or equal to 500mg;not more than 11.0%where the labeled amount of amoxicillin in each Tablet is more than 500mg.Where Tablets are labeled as chewable,not more than 6.0%where the labeled amount of amoxicillin in each Tablet is 125mg or less;not more than 8.0%where the labeled amount of amoxicillin in each Tablet is more than 125mg.Where the Tablets are labeled for veterinary use only,not more than 10.0%.
Assay—
pH4.4sodium phosphate buffer,Mobile phase,Standard preparation,andChromatographic system— Prepare as directed in the Assayunder Amoxicillin and Clavulanate Potassium for Oral Suspension.
Assay preparation— Dissolve not fewer than 10Tablets,accurately counted,in water with the aid of mechanical stirring,transfer to a suitable volumetric flask,dilute with water to volume,and mix.Filter a portion of this solution,discarding the first 10mLof the filtrate.Dilute an accurately measured volume of the filtrate quantitatively and stepwise with water to obtain a solution containing about 0.5mg of amoxicillin per mL.Use this Assay preparationwithin 1hour.
Procedure— Proceed as directed for Procedurein the Assayunder Amoxicillin and Clavulanate Potassium for Oral Suspension.Calculate the quantity,in mg,of amoxicillin (C16H19N3O5S)in each Tablet taken by the formula:
(L/D)(CP/1000)(rU/rS),
in which Lis the labeled quantity,in mg,of amoxicillin in each Tablet;Dis the concentration,in mg per mL,of amoxicillin in the Assay preparationon the basis of the number of Tablets taken,the labeled quantity of amoxicillin in each Tablet,and the extent of dilution;Cis the concentration,in mg per mL,of USP Amoxicillin RSin the Standard preparation;Pis the potency,in µg of amoxicillin per mg,of USP Amoxicillin RS,and rUand rSare the amoxicillin peak responses obtained from the Assay preparationand the Standard preparation,respectively.Calculate the quantity,in mg,of clavulanic acid (C8H9NO5)in each Tablet taken by the formula:
(L/D)(CP/1000)(rU/rS),
in which Lis the labeled quantity,in mg,of clavulanic acid in each Tablet;Dis the concentration,in mg per mL,of clavulanic acid in the Assay preparation,on the basis of the number of Tablets taken,the labeled quantity of clavulanic acid in each Tablet,and the extent of dilution;Cis the concentration,in mg per mL,of USP Clavulanate Lithium RSin the Standard preparation;Pis the designated potency,in µg of clavulanic acid per mg,of USP Clavulanate Lithium RS;and rUand rSare the clavulanic acid peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 148
Pharmacopeial Forum:Volume No.29(3)Page 605
Phone Number:1-301-816-8335