| Asysa |
USP 36 NF 31 Specification |
TEST PROD. |
REF. PROD. |
| Description |
Circular, biconvex, white, smooth on both sides tablet. Free of foreign particles |
Circular, biconvex, white, smooth on one side with trade mark Free of foreign particles |
Circular, biconvex, white, with mark on both sides, free of foreign particles |
| ID-Irbesartan |
The retention time for main peak of Standard schedule should be the same as the sample. |
Conforms |
Conforms |
| Assessment - Potassium Irbesartan |
90.0 – 110.0% of the labeled amount (300 mg /Tablet) |
102.7% of the labeled amount (308.1 mg /Tablet) |
100.7% of the labeled amount (302.1 mg /Tablet) |
| Dissolution - Potassium Irbesartan |
Should be dissolved the 80% (Q) minimum of the labeled amount in 20 minutes |
101% 102% 101% 101% 101% 101% Conforms S1 |
92% 93% 91% 87% 93% 93% Conforms S1 |
| Uniformity of Dosage Units - Irbesartan |
L1: ≤ 15 |
L1: 4 Average: 102.7% |
L1: 4 Average: 100.7% |
| Related Compounds |
There is no more than 0.2% of the related compound A of Irbesartan, there is no more than 0.2% of any individual impurity, and there is no more than 0.5% of total impurities. |
Conforms |
Conforms |
| Not detected |
Not detected |
