Physical-chemical
characteristic |
Test Product |
Reference Product |
Active ingredient assessment
90 – 110% of the labeled amount |
50,1 mg
100,2% of the declared amount |
50,1 mg
100,2% of the declared amount |
| Dosage Uniformity
L1<15 |
L1 = 2 |
L1 = 2 |
Dissolution test*
2h<30%, 4h between
30-50%, 8h between
55 – 80%, 12h between
65 – 90%, 24h > 80% |
2h
27,6% |
4h
45% |
8h
62% |
12h
76,6% |
24h
97,3% |
2h
24,6% |
4h
38,8% |
8h
59,3% |
12h
72,1% |
24h
97,3% |
| |
|
* Dissolution time mean for 12 tablets |
