Drug Samples | Drug Amount Tested (µg) | qPCR results | ddPCR results | ||
DNA Amount Quantified (fg) | Recovery of Spiked DNA (%) | Observed DNA Copies | Recovery of Spiked DNA (%) | ||
Process intermediate | 5.00 | 0.0 | 0 | 3680.0 | 96 |
2.50 | 0.0 | 0 | 3220.0 | 84 | |
1.25 | 0.0 | 0 | 3660.0 | 95 | |
0.63 | 1872.6 | 97 | 3480.0 | 90 | |
0.31 | 1888.5 | 98 | 3880.0 | 101 | |
Purified drug substance | 5.00 | 0.0 | 0 | 3540.0 | 92 |
2.50 | 0.0 | 0 | 3680.0 | 96 | |
1.25 | 0.0 | 0 | 3680.0 | 96 | |
0.63 | 2007.7 | 104 | 3740.0 | 97 | |
0.31 | 2073.3 | 107 | 3800.0 | 99 |