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.
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 (C
15H
14ClN
3O
4S)estimated to be about 25µg per mL.Determine the amount of cefaclor (C
15H
14ClN
3O
4S)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 (C
15H
14ClN
3O
4S)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% |
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 (C
15H
14ClN
3O
4S)in the portion of Tablets taken by the formula:
5WS(P/1000)(rU/rS),
in which the terms are as defined therein.