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Competitor 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