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