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.
USP Reference standards 11
USP Phenytoin RS Click to View Structure
USP Phenytoin Sodium RS Click to View Structure
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.
Assay— Proceed with Capsules as directed in the Assay under Extended Phenytoin Sodium Capsules.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Hariram Ramanathan, M.S.
Associate Scientific Liaison
(SM42010) Monographs - Small Molecules 4
Reference Standards RS Technical Services
711 Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison
(GCDF2010) General Chapters - Dosage Forms
USP35–NF30 Page 4313