| |
Product: Ketorolac tromethamine Ophthalmic solution |
| |
Strength: Ophthalmic solution (0.5% w/v) |
Batch no: OPT/KTM/T-001 |
| Description |
Clear colorless liquid filled in BFS Container |
| Stability Condition |
40°C/NMT 25% RH |
30°C/ 65% RH |
25°C/ 40% RH |
| Test parameters |
Initial AF |
Initial BF |
1 M |
2 M |
3 M |
1 M |
2 M |
3 M |
1 M |
2 M |
3 M |
| Description |
|
|
|
|
|
|
|
|
|
|
|
| Assay % |
99.7 |
99.2 |
98.5 |
98.2 |
98.2 |
98.6 |
98.4 |
98.6 |
98.4 |
98.4 |
98.6 |
| Preservative Content in % |
87.6 |
90 |
86.4 |
86.9 |
89.3 |
91.6 |
90.9 |
91.6 |
91.6 |
92.6 |
92.8 |
| Osmolality |
NA |
295 |
295 |
299 |
285 |
300 |
302 |
288 |
301 |
306 |
301 |
|
