Cefaclor Extended-Release Tablets
»Cefaclor Extended-Release Tablets contain the equivalent of not less than 90.0percent and not more than 110.0percent of the labeled amount of cefaclor (C15H14ClN3O4S).
Packaging and storage— Preserve in tight,light-resistant containers,at controlled room temperature.
Labeling— The labeling indicates the Drug Release Test with which the product complies.
USP Reference standards á11ñ— USP Cefaclor RS.USP Cefaclor,Delta-3Isomer RS.
Identification— The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Drug release á724ñ
Medium: 0.1Nhydrochloric acid;900mL.
Apparatus 1(10-mesh basket): 100rpm.
Times: 30,60,and 240minutes.
Procedure— Dilute filtered portions of the solution under test quantitatively with 0.1Nhydrochloric acid to obtain a test solution having a concentration of cefaclor (C15H14ClN3O4S)estimated to be about 25µg per mL.Determine the amount of cefaclor (C15H14ClN3O4S)dissolved by employing UVabsorption at the wavelength of maximum absorbance at about 265nm,in comparison with a Standard solution having a similar,known concentration of USP Cefaclor RSin the same Medium.
Tolerances— The percentages of the labeled amount of cefaclor (C15H14ClN3O4S)dissolved at the times specified conform to Acceptance Table 1.
Time
(minutes)		 Amount
dissolved
30 between 5%and 30%
60 between 20%and 50%
240 not less than 80%
Uniformity of dosage units á905ñ: meet the requirements.
Water,Method Iá921ñ: not more than 7.0%.
Related compounds—
Solvent,Blank solution,Solution A,Solution B,Mobile phase,Standard solution,System suitability solution,andChromatographic system— Proceed as directed for Related compoundsunder Cefaclor.
Test solution— Weigh and finely powder not fewer than 20Tablets.Transfer an accurately weighed portion of the composite,equivalent to about 50mg of cefaclor,to a 10-mLvolumetric flask.Dissolve in Solvent,using brief sonication,if necessary,to achieve dissolution.Avoid heating.Dilute with Solvent to volume,mix,and filter.Use this Test solutionwithin 3hours if stored at room temperature,or within 20hours when stored under refrigeration.
Procedure— Separately inject equal volumes (about 20µL)of the Standard solutionand the Test solutioninto the chromatograph,record the chromatograms,and measure the peak area responses for all the peaks.Calculate the mg of each related compound in the portion of Tablets taken by the formula:
0.01CP(ri/rS),
in which the terms are as defined for Related compoundsunder Cefaclor.Not more than 0.6%of any individual cefaclor-related compound is found;and the sum of all cefaclor-related compounds found is not more than 2.0%,not including the contribution of any peak that gives a result of less than 0.1%.
Assay—
Mobile phase,Standard preparation,Resolution solution,and Chromatographic system— Proceed as directed in the Assayunder Cefaclor.
Assay preparation— Weigh and finely powder not fewer than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 75mg of cefaclor,to a 250-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.Sonicate,if necessary,to dissolve the cefaclor.Filter to obtain a clear solution.
Procedure— Proceed as directed in the Assayunder Cefaclor.Calculate the quantity,in mg,of cefaclor (C15H14ClN3O4S)in the portion of Tablets taken by the formula:
5WS(P/1000)(rU/rS),
in which the terms are as defined therein.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 371
Pharmacopeial Forum:Volume No.28(4)Page 1245
Phone Number:1-301-816-8335