DISSOLUTION<711>
[NoTE-Tablets labeled for veterinary use only areexempt from this requirement.]
Test 1
Medium:Water:900 ml
Apparatus 2:75 rpm
Time:30 min;or 45 min where the Tablets are labeled as chewable
Analysis:Determine the amount of C16H19N3O5S and C8H9NO5 dissolved, using the Analysis set forth in the Assay, making any necessary volumetric adjustments.
Tolerances:NLT85% (Q) of the labeled amount of C16H19N3O5S and NLT 80% (Q) of the labeled amount of C8H9NO5 are dissolved.
For Tablets labeled as chewable:NLT 80% (Q) of thelabeled amounts of C16H19N3O5S and C8H9NO5 is dissolved in 45 min.
Test 2:lf the product complies with this test, the labeling indicates that it meets USP Disolution Test 2.
Medium, Apparatus 2,and Analysis:Proceed asdirected for Test 1.
Times:45 min for amoxicillin, and 30 min for clavulanic acid
Tolerances:NLT 85%(Q)of the labeled amount of C16H19N3O5S and NLT 80% (Q) of the labeled amount of C8H9NO5 are dissolved.