Table 3.
Content (%) |
Dissolution (%) |
||||
---|---|---|---|---|---|
Low fail |
Pass | High fail |
Low fail |
Pass | |
AQ tablets | 10 (34·5) |
19 (65·5) |
0 | 4 (13·8) |
25 (86·2) |
AQ suspensions |
6 (26·1) |
16 (69·6) |
1 (4·3) |
na | na |
na, Not applicable.
Amount AQ is expressed as per cent label claim. USP limits for content of AQ range from 93% to 107% and amount AQ released into dissolution medium within 30 min should be ≥75%. Pass means within limit, and low and high fail means lower or higher than limit, respectively.