USP Monographs: Nafcillin Sodium for Oral Solution

Nafcillin Sodium for Oral Solution

» Nafcillin Sodium for Oral Solution contains not less than 90.0 percent and not more than 120.0 percent of the labeled amount of nafcillin (C21H22N2O5S). It contains one or more suitable buffers, colors, diluents, dispersants, flavors, and preservatives.

Packaging and storage— Preserve in tight containers.

USP Reference standards

— USP Nafcillin 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 5.5 and 7.5, in the solution constituted as directed in the labeling.

Water, Method I

921

: not more than 5.0%.

Residual solvents

467

: meets the requirements.

(Official January 1, 2007)

Assay— Proceed as directed under Antibiotics—Microbial Assays

, using Nafcillin Sodium for Oral Solution constituted as directed in the labeling. Dilute an accurately measured volume of the solution quantitatively with Buffer No. 1 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.

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

Expert Committee : (MDANT05) Monograph Development-Antibiotics

USP29–NF24 Page 1470

Phone Number : 1-301-816-8223


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