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Determination of CPS and its related substances in drug substance
| Sample |
Known related substances (%)
|
Unknown
Impurity (%) |
Total Impurities (% ) | Assay (% ) | ||
|---|---|---|---|---|---|---|
| Imp-1 | Imp-2 | Imp-3 | ||||
| Batch I | 0.03 | 0.01 | 0.02 | ND | 0.05 | 100.31 |
| Batch II | 0.03 | 0.01 | 0.01 | ND | 0.05 | 100.36 |
| Batch III | 0.03 | 0.00 | 0.02 | ND | 0.04 | 100.99 |
ND: not detected
