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Table 23 Robustness study results of dichloromethane

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

10.13

13982

1.3

2.5

3.2

9.21

12547

1.4

2.7

2.8

8.29

11857

1.5

Column oven temperature (± 5 °C)

35 °C

3.1

10.14

12478

1.2

40 °C

3.2

9.21

12547

1.4

45 °C

3.1

8.34

13415

1.3

Vial oven temperature (± 5 °C)

85 °C

3.4

9.20

12145

1.1

90 °C

3.2

9.21

12547

1.4

95 °C

3.2

9.19

13245

1.2