U.S. PHARMACOPEIA

Search USP29  
Cefadroxil for Oral Suspension
» Cefadroxil for Oral Suspension is a dry mixture of Cefadroxil and one or more suitable buffers, colors, diluents, and flavors. It contains the equivalent of not less than 90.0 percent and not more than 120.0 percent of the labeled amount of C16H17N3O5S.
Packaging and storage— Preserve in tight containers.
Identification— Constitute 1 container of Cefadroxil for Oral Suspension as directed in the labeling. Mix a portion of the resulting suspension with water to obtain a concentration of about 2 mg of cefadroxil per mL, and filter: the filtrate so obtained responds to Identification test B under Cefadroxil.
Uniformity of dosage units 905—
FOR SOLID PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume 698: meets the requirements.
pH 791: between 4.5 and 6.0, in the suspension constituted as directed in the labeling.
Water, Method I 921: not more than 2.0%.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
pH 5.0 Buffer, Mobile phase, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Cefadroxil.
Assay preparation— Constitute a container of Cefadroxil for Oral Suspension as directed in the labeling. Transfer an accurately measured volume of the oral suspension thus obtained, equivalent to about 250 mg of cefadroxil, to a 250-mL volumetric flask, dilute with pH 5.0 buffer to volume, and stir by mechanical means for 5 minutes. Pass about 25 mL of the resulting solution through a suitable filter of 0.8 µm or finer porosity, and use the clear filtrate as the Assay preparation. Use this solution on the day prepared.
Procedure— Proceed as directed for Procedure in the Assay under Cefadroxil. Calculate the quantity, in mg, of C16H17N3O5S in each mL of Cefadroxil for Oral Suspension taken by the formula:
0.25(CE / V)(rU / rS),
in which V is the volume, in mL, of Cefadroxil for Oral Suspension taken, and the other terms are as defined therein.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 404
Pharmacopeial Forum : Volume No. 31(4) Page 1045
Phone Number : 1-301-816-8223