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Table 26 Robustness study results of tetrahydrofuran

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

2.9

15.53

97542

1.0

2.5

2.8

14.12

97845

1.0

2.7

2.7

12.71

97441

1.1

Column oven temperature (± 5 °C)

35 °C

2.7

15.55

97635

1.3

40 °C

2.8

14.12

97845

1.0

45 °C

2.7

12.74

97412

1.2

Vial oven temperature (± 5 °C)

85 °C

2.7

14.11

97458

1.4

90 °C

2.8

14.12

97845

1.0

95 °C

2.7

14.12

96547

1.3