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.
Assay
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.
Auxiliary Information
Staff Liaison :
Behnam Davani, Ph.D., MBA, Senior Scientist
Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials
USP29NF24 Page 2019
Pharmacopeial Forum : Volume No. 29(3) Page 670
Phone Number : 1-301-816-8394