Triple Sulfa Vaginal Inserts
» Triple Sulfa Vaginal Inserts contain not less than 90.0 percent and not more than 110.0 percent of the labeled amounts of sulfathiazole (C9H9N3O2S2), sulfacetamide (C8H10N2O3S), and sulfabenzamide (C13H12N2O3S).
Packaging and storage— Preserve in well-closed, light-resistant containers.
Identification— The retention times of the major peaks in the chromatogram of the Assay preparation correspond to those in the chromatogram of the Standard preparation, as obtained in the Assay.
Disintegration 701: 30 minutes.
Uniformity of dosage units 905: meet the requirements for Weight Variation with respect to sulfathiazole, to sulfacetamide, and to sulfabenzamide.
Mobile phase, Internal standard solution, and Standard preparation— Prepare as directed in the Assay under Triple Sulfa Vaginal Cream.
Assay preparation— Weigh and finely powder not fewer than 10 Vaginal Inserts. Transfer an accurately weighed portion of the powder, equivalent to about 144 mg of sulfacetamide, 184 mg of sulfabenzamide, and 173 mg of sulfathiazole, to a 250-mL volumetric flask. Add 10.0 mL of water, and shake for 10 minutes. Add 10.0 mL of Internal standard solution and 100 mL of acetone, and shake for 30 minutes at low speed on a mechanical shaker. Dilute with acetone to volume, mix, and allow to stand for 30 minutes. Pipet 5 mL of the clear supernatant into a 50-mL volumetric flask, and evaporate on a steam bath with the aid of a gentle stream of nitrogen to dryness. Dissolve the residue in Mobile phase, dilute with Mobile phase to volume, and mix.
Chromatographic system and Procedure— Proceed with the Vaginal Inserts as directed in the Assay under Triple Sulfa Vaginal Cream.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Behnam Davani, Ph.D., M.B.A.
Senior Scientist
(MDAA05) Monograph Development-Antivirals and Antimicrobials
Reference Standards Lili Wang, Technical Services Scientist
701 Margareth R.C. Marques, Ph.D.
Senior Scientist
(BPC05) Biopharmaceutics05
USP32–NF27 Page 3612
Pharmacopeial Forum: Volume No. 29(3) Page 670
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.