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Table 27 Robustness study results of DIPEA

From: Determination of residual solvents in paclitaxel by headspace gas chromatography

Parameter

System conditions

Percentage RSD for peak area (n = 6)

Retention time

Plate count

Tailing factor

Flow rate (± 0.2 mL/min)

2.3

3.9

19.20

93487

1.1

2.5

3.5

17.45

98751

1.2

2.7

3.4

15.72

95249

1.1

Column oven temperature (± 5 °C)

35 °C

3.1

19.23

97541

1.2

40 °C

3.5

17.45

98751

1.2

45 °C

3.2

15.74

96324

1.2

Vial oven temperature (± 5 °C)

85 °C

3.4

17.46

97547

1.3

90 °C

3.5

17.45

98751

1.2

95 °C

3.5

17.42

97452

1.2