Table 3 Summary of drug product application results
Test parameter | Sample name | Result | ||
|---|---|---|---|---|
PGI-1 | PGI-2 | PGI-3 | ||
Product samples analysis | Arpizol 5 Tablet | BDL | BDL | BDL |
Asprito 5 Tablet | BDL | BDL | BDL | |
Arip MT 5 Tablet | BDL | BDL | BDL | |
Accuracy | Typical acceptance criteria | 98.2% | 96.4% | 97.1% |
Average recovery (n = 3) from the spiked drug product samples performed at 100% level | ||||