USP Monographs: Cloxacillin Sodium for Oral Solution

Cloxacillin Sodium for Oral Solution

» Cloxacillin Sodium for Oral Solution is a dry mixture of Cloxacillin Sodium and one or more suitable buffers, colors, flavors, and preservatives. It contains the equivalent of not less than 90.0 percent and not more than 120.0 percent of the labeled amount of cloxacillin (C19H18ClN3O5S).

Packaging and storage— Preserve in tight containers.

USP Reference standards

— USP Cloxacillin Sodium RS.

Uniformity of dosage units

905

—

FOR SOLID PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.

Deliverable volume

698

: meets the requirements.

791

: between 5.0 and 7.5, in the solution constituted as directed in the labeling.

Water, Method I

921

: not more than 1.0%.

Residual solvents

467

: meets the requirements.

(Official January 1, 2007)

Assay—

Buffer, Mobile phase, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Cloxacillin Sodium.

Assay preparation— Constitute Cloxacillin Sodium for Oral Solution as directed in the labeling. Transfer an accurately measured volume of the resulting solution, equivalent to about 125 mg of cloxacillin, to a 250-mL volumetric flask, dilute with Buffer to volume, mix, and stir for 15 minutes. Filter about 25 mL of this mixture, discarding the first 5 mL of the filtrate. Use the clear filtrate as the Assay preparation.

Procedure— Proceed as directed for Procedure in the Assay under Cloxacillin Sodium. Calculate the quantity, in mg, of cloxacillin (C19H18ClN3O5S) in the portion of Cloxacillin Sodium for Oral Solution taken by the formula:

0.25CE(rU / rS),

in which the terms are as defined therein.

Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist

Expert Committee : (MDANT05) Monograph Development-Antibiotics

USP29–NF24 Page 574

Pharmacopeial Forum : Volume No. 28(4) Page 1092

Phone Number : 1-301-816-8223


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