Cefaclor Chewable Tablets
» Cefaclor Chewable Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of cefaclor (C15H14ClN3O4S).
Packaging and storage— Preserve in tight containers. Store at 25, excursions permitted between 15 and 30.
Labeling— The product label and product labeling indicate that the Chewable Tablets must be chewed or crushed before administration.
USP Reference standards 11—
USP Cefaclor RS Click to View Structure
USP Cefaclor Delta-3 Isomer RS
Identification— The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Dissolution 711—
Medium: water; 900 mL.
Apparatus 2: 50 rpm.
Time: 30 minutes.
Procedure— Determine the amount of cefaclor dissolved by employing UV absorption at the wavelength of maximum absorbance at about 264 nm on filtered portions of the solution under test, suitably diluted with Medium, if necessary, in comparison with a Standard solution having a known concentration of USP Cefaclor RS in the same Medium. Calculate the amount of cefaclor dissolved by the formula:
Click to View Image
in which AU and AS are the absorbances obtained from the solution under test and the Standard solution, respectively; CS is the concentration, in mg per mL, of the Standard solution; 900 is the volume, in mL, of Medium; 100 is the conversion factor to percentage; D is the dilution factor of the solution under test; and LC is the Tablet label claim, in mg.
Tolerances— Not less than 80% (Q) of the labeled amount of cefaclor is dissolved in 30 minutes.
Uniformity of dosage units 905: meet the requirements.
Water, Method I 921: not more than 5.0%.
Related compounds—
Solvent, Blank solution, Solution A, Solution B, Mobile phase, Standard solution, System suitability solution, and Chromatographic system— Proceed as directed for Related compounds under Cefaclor.
Test solution— Weigh and finely powder not fewer than 20 Chewable Tablets. Transfer an accurately weighed portion of the composite, equivalent to about 50 mg of cefaclor, to a 10-mL volumetric flask. Dissolve in Solvent, using brief sonication, if necessary, to dissolve. Avoid heating. Dilute with Solvent to volume, mix, and filter. [note—Use this Test solution within 3 hours if stored at room temperature, or within 20 hours when stored under refrigeration. ]
Procedure— Separately inject equal volumes (about 20 µL) of the Standard solution and the Test solution into the chromatograph, record the chromatograms, and measure the peak area responses for all the peaks. Calculate the quantity, in mg, of each related compound in the portion of Chewable Tablets taken by the formula:
0.01CP(ri / rS)
in which the terms are as defined for Related compounds under Cefaclor. Not more than 1.0% of any individual cefaclor related compound is found; and the sum of all cefaclor related compounds found is not more than 3.0%, 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 Assay under Cefaclor.
Assay preparation— Weigh and finely powder not fewer than 20 Chewable Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 75 mg of cefaclor, to a 250-mL volumetric flask, dilute with Mobile phase to volume, and mix. Sonicate, if necessary, to dissolve the cefaclor. Filter to obtain a clear solution.
Procedure— Proceed as directed in the Assay under Cefaclor. Calculate the quantity, in mg, of cefaclor (C15H14ClN3O4S) in the portion of Chewable Tablets taken by the formula:
5WS (P/1000)(rU / rS)
in which the terms are as defined therein.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Senior Scientific Liaison
1-301-816-8161		 (SM12010) Monographs - Small Molecules 1
Reference Standards RS Technical Services
1-301-816-8129
rstech@usp.org
711 Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison
1-301-816-8106		 (GCDF2010) General Chapters - Dosage Forms
USP35–NF30 Page 2527
Pharmacopeial Forum: Volume No. 33(4) Page 641