Sulfisoxazole Acetyl Oral Suspension
»Sulfisoxazole Acetyl Oral Suspension contains an amount of Sulfisoxazole Acetyl equivalent to not less than 93.0percent and not more than 107.0percent 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 Identificationtests Aand Bunder Sulfisoxazole Acetyl.
Uniformity of dosage units á905ñ—
FOR ORAL SUSPENSION PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume á698ñ—
FOR ORAL SUSPENSION PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.
pHá791ñ: between 5.0and 5.5.
Assay— Transfer an accurately measured volume of Oral Suspension,previously mixed,equivalent to about 1g of sulfisoxazole,to a 250-mLbeaker.Add 40mLof hydrochloric acid and 25mLof glacial acetic acid,and swirl to dissolve.Cautiously add 100mLof water,and proceed as directed under Nitrite Titration á451ñ,beginning with “Cool to about 15.”Each mLof 0.1Msodium nitrite is equivalent to 26.73mg of sulfisoxazole (C11H13N3O3S).
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1837
Pharmacopeial Forum:Volume No.29(6)Page 1990
Phone Number:1-301-816-8394