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Amoxicillin and Clavulanate Potassium Tablets
» Amoxicillin and Clavulanate Potassium Tablets contain the equivalent of not less than 90.0 percent and not more than 120.0 percent 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 preparation correspond to those in the chromatogram of the Standard preparation, as obtained in the Assay.
Disintegration 701: Tablets labeled for veterinary use only; 30 minutes, simulated gastric fluid TS being substituted for water in the test.
Dissolution 711— [NOTE—Tablets labeled for veterinary use only are exempt from this requirement.]
Medium: water; 900 mL.
Apparatus 2: 75 rpm.
Time: 30 minutes; or 45 minutes 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 C16H19N3O5S and not less than 80% (Q) of the labeled amount of C8H9NO5 are dissolved in 30 minutes.
FOR TABLETS LABELED AS CHEWABLE— Not less than 80% (Q) of the labeled amounts of C16H19N3O5S and C8H9NO5 is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements for Weight Variation with respect to amoxicillin and for Content Uniformity with respect to clavulanic acid.
Water, Method I 921: not more than 7.5% where the labeled amount of amoxicillin in each Tablet is 250 mg or less; not more than 10.0% where the labeled amount of amoxicillin in each Tablet is more than 250 mg but less than or equal to 500 mg; not more than 11.0% where the labeled amount of amoxicillin in each Tablet is more than 500 mg. Where Tablets are labeled as chewable, not more than 6.0% where the labeled amount of amoxicillin in each Tablet is 125 mg or less; not more than 8.0% where the labeled amount of amoxicillin in each Tablet is more than 125 mg. Where the Tablets are labeled for veterinary use only, not more than 10.0%.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Assay—
pH 4.4 Sodium phosphate buffer, Mobile phase, Standard preparation, and Chromatographic system— Prepare as directed in the Assay under Amoxicillin and Clavulanate Potassium for Oral Suspension.
Assay preparation— Dissolve not fewer than 10 Tablets, 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 10 mL of the filtrate. Dilute an accurately measured volume of the filtrate quantitatively and stepwise with water to obtain a solution containing about 0.5 mg of amoxicillin per mL. Use this Assay preparation within 1 hour.
Procedure— Proceed as directed for Procedure in the Assay under 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 L is the labeled quantity, in mg, of amoxicillin in each Tablet; D is the concentration, in mg per mL, of amoxicillin in the Assay preparation on the basis of the number of Tablets taken, the labeled quantity of amoxicillin in each Tablet, and the extent of dilution; C is the concentration, in mg per mL, of USP Amoxicillin RS in the Standard preparation; P is the potency, in µg of amoxicillin per mg, of USP Amoxicillin RS, and rU and rS are the amoxicillin peak responses obtained from the Assay preparation and 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 L is the labeled quantity, in mg, of clavulanic acid in each Tablet; D is 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; C is the concentration, in mg per mL, of USP Clavulanate Lithium RS in the Standard preparation; P is the designated potency, in µg of clavulanic acid per mg, of USP Clavulanate Lithium RS; and rU and rS are the clavulanic acid peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 162
Pharmacopeial Forum : Volume No. 29(3) Page 605
Phone Number : 1-301-816-8223