Prompt Phenytoin Sodium Capsules, chemical structure, molecular formula, Reference Standards

Prompt Phenytoin Sodium Capsules

»Prompt Phenytoin Sodium Capsules contain not less than 95.0percent and not more than 105.0percent of the labeled amount of C15H11N2NaO2.

Packaging and storage— Preserve in tight containers.

Labeling— Label the Capsules with the statement “Not for once-a-day dosing,”printed immediately under the official name,in a bold and contrasting color and/or enclosed within a box.

USP Reference standards á11ñ— USP Phenytoin RS.USP Phenytoin Sodium RS.

Identification—

A: The contents of Capsules respond to Identificationtest Aunder Phenytoin Sodium.

B: The contents of Capsules respond to the flame test for Sodium á191ñ.

Dissolution á711ñ—

Medium: water;900mL.

Apparatus 1: 50rpm.

Time: 30minutes.

Procedure— Determine the amount of C15H11N2NaO2dissolved by measuring the UVabsorbance at 258nm on filtered portions of the solution under test,suitably diluted with Dissolution Mediumif necessary,in comparison with a Standard solution having a known concentration of USP Phenytoin Sodium RSin the same Medium.

Tolerances— Not less than 85%(Q)of the labeled amount of C15H11N2NaO2is dissolved in 30minutes.

Uniformity of dosage units á905ñ: meet the requirements.

Procedure for content uniformity— Proceed as directed in the test for Uniformity of dosage unitsunder Extended Phenytoin Sodium Capsules.

Assay— Proceed with Capsules as directed in the Assayunder Extended Phenytoin Sodium Capsules.

Auxiliary Information— Staff Liaison:Salvador C.Salado,M.S.,Scientist and Latin American Liaison

Expert Committee:(PA3)Pharmaceutical Analysis 3

USP28–NF23Page 1553

Phone Number:1-301-816-8165