695
GCCHROMATOGRAMS |
PHARMACEUTICAL
Organic Volatile Impurities/Residual Solvents
Column:
Rxi
®
-624Sil MS, 30m, 0.32mm ID, 1.80µm (cat.# 13870)
Sample:
Residual Solvents Class 2 - Mix B (cat.# 36280)
Diluent:
water
Injection:
headspace-loop split (split ratio 5:1)
Liner:
1mm Split (cat.# 20972)
Headspace-Loop
Inj. PortTemp.:
140 °C
Instrument:
Tekmar HT3
Inj.Time:
1min.
Transfer LineTemp.:
110 °C
ValveOvenTemp.:
110 °C
SampleTemp.:
80 °C
Sample Equil.Time:
60min.
Vial Pressure:
10 psi
PressurizeTime:
0.5min.
Pressure EquilibrationTime: 0.05min.
Loop Pressure:
5 psi
Loop FillTime:
0.1min.
Oven
OvenTemp:
40 °C (hold 20min.) to 240 °C at 10 °C/min. (hold 20min.)
Carrier Gas:
He, constant flow
Linear Velocity:
35 cm/sec.
DeadTime:
1.45min.@ 40 °C
Detector:
FID@ 250 °C
Data Rate:
5Hz
Instrument:
Agilent/HP6890GC
Acknowledgement:
TeledyneTekmar
Peaks
RT (min.) Conc. (µg/mL)
1. Hexane
5.355
2.42
2. Nitromethane
6.793
0.42
3. Chloroform
8.092
0.50
4. 1,2-Dimethoxyethane
9.980
0.83
5.Trichloroethene
12.941
0.67
6. Pyridine
21.303
1.67
7. 2-Hexanone
24.862
0.42
8.Tetralin
33.781
0.83
GC_PH1148
Class2—MixBResidualSolvents forWater-SolubleArticlesonRxi®-624SilMS
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ResidualSolventAnalysis
ImplementingUSP<467>
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Mar 2011
