| Product |
Ketorolac Tromethamine Ophthalmic Solution 0.5% |
Pack: 3 Piece container and BFS –5 mL |
| Condition |
Time points |
Analytical parameters |
Number of samples |
| Description assay |
Rs |
Preservative content |
Osmolality and Drop size study |
pH |
40°C ± 2°C/
not more than
(NMT) 25% RH |
INT |
(2) |
(2) |
(2) |
(1) |
(1) |
00 |
| 2 w |
(2) |
(2) |
(2) |
(1) |
(1) |
08 |
| 1 M |
(2) |
(2) |
(2) |
(1) |
(1) |
08 |
| 2 M |
(2) |
(2) |
(2) |
(1) |
(1) |
08 |
| 3 M |
(2) |
(2) |
(2) |
(1) |
(1) |
08 |
| 6 M |
(2) |
(2) |
(2) |
(1) |
(1) |
08 |
25°C ± 2°C/
40% ± 5% RH |
1 M |
(2) |
(2) |
(2) |
(1) |
(1) |
08 |
| 3 M |
(2) |
(2) |
(2) |
(1) |
(1) |
08 |
| 6 M |
(2) |
(2) |
(2) |
(1) |
(1) |
08 |
| 30°C ± 2°C/
65% ± 5% RH |
1 M |
(2) |
(2) |
(2) |
(1) |
(1) |
08 |
| 3 M |
(2) |
(2) |
(2) |
(1) |
(1) |
08 |
| 6 M |
(2) |
(2) |
(2) |
(1) |
(1) |
08 |
| 60°C |
1 w |
(2) |
(2) |
(2) |
(1) |
(1) |
08 |
| 2 w |
(2) |
(2) |
(2) |
(1) |
(1) |
08 |
| 1 M |
(2) |
(2) |
(2) |
(1) |
(1) |
08 |
| Total |
|
112 |
|
