U.S. PHARMACOPEIA

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Prompt Phenytoin Sodium Capsules
» Prompt Phenytoin Sodium Capsules contain not less than 95.0 percent and not more than 105.0 percent 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.
Identification—
A: The contents of Capsules respond to Identification test A under Phenytoin Sodium.
B: The contents of Capsules respond to the flame test for Sodium 191.
Dissolution 711—
Medium: water; 900 mL.
Apparatus 1: 50 rpm.
Time: 30 minutes.
Procedure— Determine the amount of C15H11N2NaO2 dissolved by measuring the UV absorbance at 258 nm on filtered portions of the solution under test, suitably diluted with Dissolution Medium if necessary, in comparison with a Standard solution having a known concentration of USP Phenytoin Sodium RS in the same Medium.
Tolerances— Not less than 85% (Q) of the labeled amount of C15H11N2NaO2 is dissolved in 30 minutes.
Uniformity of dosage units 905: meet the requirements.
Procedure for content uniformity— Proceed as directed in the test for Uniformity of dosage units under Extended Phenytoin Sodium Capsules.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Assay— Proceed with Capsules as directed in the Assay under Extended Phenytoin Sodium Capsules.
Auxiliary Information— Staff Liaison : Ravi Ravichandran, Ph.D., Senior Scientist
Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives
USP29–NF24 Page 1725
Phone Number : 1-301-816-8330