| Name of Product | |||||||
| Standard Name | Mw-I (Base) | Mw-II (Salt) | Potency | ||||
| Standard Preparation | ||||||||
| STD-Stock-I | STD-Stock-II | STD-Stock-III | STD-Stock-IV | Conc (µg/ml) | ||||
| wt (mg) | Dilution (ml) | ml Taken | Dilution | ml | Dilution | ml | Dilution | |
| 0.000000 | ||||||||
| Injection | 1 | 2 | 3 | 4 | 5 | 6 | Mean | BKT-1 | BKT-2 | BKT-3 |
| Standard Area | 0.00 | |||||||||
| RSD | 0.00 | 0.00 | 0.00 | 0.00 | ||||||
| Theoretical Sample Preparation | Average Wt (mg) | L.C. (mg) | |||||
| Sample wt (EQ) | Dilution | ml Taken | Dilution | Conc. (µg/ml) | |||
| 0.000 | |||||||
| Impurity Preparation for Spiking | ||||||||||
| Impurity Name | Potency | MW-I (Base) | Mw-II (Salt) | RRF | ||||||
| As Such Sample | SET-I (wt) mg | SET-II (wt) mg | SET-III (wt) mg | Mean |
| Absolute Test Conc. (µg/ml) | ||||
| 0 | 0 | 0 | ||
| Impurity Area | 0 | |||
| % Impurity Found | 0.0000 | 0.0000 | 0.0000 | 0.0000 |
| Level Name | Set | Sample wt(mg) | Impurity Stock Used | ml Added | Impurity Area | Amount added (%) | Amount Found (%) | % Recovery | Average Recovery | % RSD | Actions |
|---|