Sulfisoxazole Acetyl Oral Suspension
» Sulfisoxazole Acetyl Oral Suspension contains an amount of Sulfisoxazole Acetyl equivalent to not less than 93.0 percent and not more than 107.0 percent of the labeled amount of sulfisoxazole (C11H13N3O3S).
Packaging and storage— Preserve in tight, light-resistant containers.
Identification— Centrifuge a portion of it, wash the separated solid by centrifugation with several portions of water, and recrystallize from hot alcohol: the crystals so obtained respond to Identification tests A and B under Sulfisoxazole Acetyl.
Uniformity of dosage units 905
for oral suspension packaged in single-unit containers: meets the requirements.
Deliverable volume 698
for oral suspension packaged in multiple-unit containers: meets the requirements.
pH 791: between 5.0 and 5.5.
Assay— Transfer an accurately measured volume of Oral Suspension, previously mixed, equivalent to about 1 g of sulfisoxazole, to a 250-mL beaker. Add 40 mL of hydrochloric acid and 25 mL of glacial acetic acid, and swirl to dissolve. Cautiously add 100 mL of water, and proceed as directed under Nitrite Titration 451, beginning with “Cool to about 15.” Each mL of 0.1 M sodium nitrite is equivalent to 26.73 mg of sulfisoxazole (C11H13N3O3S).
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
USP32–NF27 Page 3636
Pharmacopeial Forum: Volume No. 29(6) Page 1990