| Product Name | Standard Name | ||
| Impurity Standard Details | |||
| Mw-I (Base) | Mw-II (Salt) | Potency (%) | RRF |
| Standard Preparation | ||||||||
| STD-Stock-I | STD-Stock-II | STD-Stock-III | STD-Stock-IV | Conc (µg/ml) | ||||
| wt (mg) | Dilution | ml Taken | Dilution | ml | Dilution | ml | Dilution | |
| - | ||||||||
| Standard Area Injections | ||||||||||
| Inj-1 | Inj-2 | Inj-3 | Inj-4 | Inj-5 | Inj-6 | Mean | RSD (%) | BKT-1 | BKT-2 | BKT-3 |
| - | - | |||||||||
| BKT RSD (%) | - | - | - | |||||||
| Theoretical Sample Preparation | Avg Wt (mg) | L.C. (mg) | ||||
| Sample wt | Dilution | ml Taken | Dilution | Conc. (µg/ml) | ||
| - | ||||||
| Impurity Preparation for Spiking | |||||||
| Impurity Name | Potency | MW-I (Base) | MW-II (Salt) | ||||
| As Such Sample Analysis | ||||
| As Such Set | SET-I (wt) mg | SET-II (wt) mg | SET-III (wt) mg | Mean |
| Sample Weight | - | |||
| Assay Conc (µg/ml) | - | - | - | - |
| Impurity Area | - | |||
| % Impurity Found | - | - | - | - |
| Recovery Study | |||||||||||
| Level Name | Set | Sample wt(mg) | Stock Used | ml Added | Imp Area | Added (%) | Found (%) | % Recovery | Avg Rec | % RSD | Del |