677-697_GCappPharm.qxp
11/19/2008
5:10 PM
Page 692
GC APPLICATIONS | PHARMACEUTICAL
Organic Volatile Impurities/Residual Solvents Residual Solvents Class 1 Rtx®-1301 Column: Sample: Inj.: Inj. temp.: Carrier gas: Flow rate: Oven temp.: Det.:
1. 2. 3. 4. 5.
Rtx®-1301, 30m, 0.32mm ID, 1.8µm (cat.# 16092) USP <467> Class 1 standard solution (cat.# 36279) in 20mL headspace vial headspace injection (split ratio 1:5), 1mm split liner, Siltek® deactivated (cat.# 20972-214.1) 140°C helium, constant flow 2.16mL/min., 35.3cm/sec. 40°C for 20 min. to 240°C @ 10°C/min. (hold for 20 min.) FID @ 240°C
Headspace Conditions Instrument: Transfer line temp.: Valve oven temp.: Sample temp.: Sample equil. time: Vial pressure: Pressurize time: Loop fill pressure: Loop fill time: Inject time:
Tekmar HT3 105°C 105°C 80°C 45 min. 10psi 0.5 min. 5psi 2.00 min. 1.00 min.
1,1-dichloroethene 1,1,1-trichloroethane carbon tetrachloride benzene 1,2-dichloroethane
GC_PH00909
Residual Solvents Class 2 Mixture A Rtx®-1301
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14.
2. acetonitrile (resolution = 1.35) 3. dichloromethane
Meets system suitability requirements for USP<467>.
methanol acetonitrile (resolution=1.35) dichloromethane trans-1,2-dichloroethene cis-1,2-dichloroethene tetrahydrofuran cyclohexane methylcyclohexane 1,4-dioxane toluene chlorobenzene ethyl benzene m-xylene/p-xylene o-xylene
9. 1,4-dioxane
GC_PH00910
Column: Sample: Inj.: Inj. temp.: Carrier gas: Flow rate: Oven temp.: Det.:
692 www.restek.com
Rtx®-1301, 30m, 0.32 ID, 1.8µm (cat.# 16092) USP <467> Class 2 Mixture A standard solution (cat.# 36271) in 20mL headspace vial headspace injection (split ratio 1:5), 1mm split liner, Siltek® deactivated (cat.# 20972-214.1) 140°C helium, constant flow 2.16mL/min., 35.3cm/sec. 40°C for 20 min. to 240°C @ 10°C/min. (hold for 20 min.) FID @ 240°C
Headspace Conditions Instrument: Transfer line temp.: Valve oven temp.: Sample temp.: Sample equil. time: Vial pressure: Pressurize time: Loop fill pressure: Loop fill time: Inject time:
Tekmar HT3 105°C 105°C 80°C 45 min. 10psi 0.5 min. 5psi 2.00 min. 1.00 min.
800-356-1688 or 814-353-1300
