Application Of A Dissolution Test Using Crescent-Shaped Spindle (CSS) To Evaluate Assay And Uniformity Of Dosage Units Parameters

Methods: Acetaminophen (7) and prednisone (3) tablet products were tested. The dissolution test conditions (USP): 900 mL phosphate buffer (pH 5.8) for acetaminophen and 500 mL water for prednisone; 50 rpm; test duration=60 min with sampling every 10 min. Assay and UDU were evaluated as per respective USP monographs. In the case of testing using the CSS, all tests were conducted using spindle at 25 rpm with 900 mL of water. The results of the last sampling time (60 min) from the dissolution tests were used for the assessment of assay and UDU parameters.