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www.restek.comCompetitor Comparison: Class 2 - Mix A Residual Solvents for USP <467>Water-Soluble Articles
GC COLUMNS |
APPLICATION-SPECIFIC COLUMNS
Pharmaceutical
Organic Volatile Impurities (OVI) Analysis
GC_PH1161
Column
Rxi®-624Sil MS, 30 m, 0.32 mm ID, 1.80 µm (cat.# 13870)
Sample
Residual solvents class 2 - mix A (cat.# 36271)
Diluent:
Water
Injection
Headspace-loop split (split ratio 5:1)
Liner:
1 mm split (cat.# 20972)
Headspace-Loop
Inj. Port Temp.:
140 °C
Instrument:
Tekmar HT3
Inj. Time:
1 min
Transfer Line Temp.:
110 °C
Valve Oven Temp.:
110 °C
Sample Temp.:
80 °C
Sample Equil. Time:
60 min
Vial Pressure:
10 psi
Pressurize Time:
0.5 min
Pressure
Equilibration Time: 0.05 min
Loop Pressure:
5 psi
Loop Fill Time:
0.1 min
Oven
Oven Temp.:
40 °C (hold 20 min) to 240 °C at 10 °C/min (hold 20 min)
Carrier Gas
He, constant flow
Linear Velocity:
35 cm/sec
Dead Time:
1.45 min @ 40 °C
Detector
FID@ 250 °C
Data Rate:
5 Hz
Instrument
Agilent/HP6890 GC
Acknowledgement
Teledyne Tekmar
Peaks
tR (min)
Conc.
(µg/mL)
1. Methanol
2.281
25.00
2. Acetonitrile
4.009
3.42
3. Dichloromethane
4.313
5.00
4.
trans
-1,2-Dichloroethene
4.798
7.83
5.
cis
-1,2-Dichloroethene
7.028
7.83
6. Tetrahydrofuran
7.706
5.75
7. Cyclohexane
8.708
32.33
8. Methylcyclohexane
14.099
9.83
9. 1,4-Dioxane
15.054
3.17
10. Toluene
22.018
7.42
11. Chlorobenzene
26.570
3.00
12. Ethylbenzene
26.837
3.07
13.
m
-Xylene
27.147
10.85
14.
p
-Xylene
27.147
2.53
15.
o
-Xylene
27.927
1.63
Improve system suitability pass rates
with greater resolution on Rxi®-624Sil MS
columns.
Similar to: (6%-cyanopropylphenyl)-methylpolysiloxane
Rxi®-624Sil MS Columns
(fused silica)
(midpolarity Crossbond® phase)
• Low-bleed, high-thermal stability column—maximum temperatures up to 320 °C.
• Inert—excellent peak shape for a wide range of compounds.
• Selective—G43 phase highly selective for volatile organics and residual solvents,
great choice for USP<467>.
• Manufactured for column-to-column reproducibility—well-suited for validated
methods.
Rxi®-624Sil MS Structure
x
Si
O
(CH
2
)
3
CH
3
CH
3
CH
3
Si
O
R
O
CH
3
CH
3
Si
94%
y
CH
3
CH
3
Si
C N
similar phases
DB-624, VF-624ms, CP-Select 624 CB
20-Meter
30-Meter
60-Meter
75-Meter
105-Meter
ID df
temp. limits cat.#
price
cat.#
price
cat.#
price
cat.#
price
cat.#
price
0.18 mm 1.00 µm -20 to 300/320 °C 13865
0.25 mm 1.40 µm -20 to 300/320 °C
13868
13869
0.32 mm 1.80 µm -20 to 300/320 °C
13870
13872
0.53 mm 3.00 µm -20 to 280/300 °C
13871
13873
13874
13875
G43 phase