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97

GC COLUMNS |

APPLICATION-SPECIFIC COLUMNS

Pharmaceutical

Rtx®-G27 Column

(fused silica with 5-meter Integra-Guard® guard column)

(Crossbond® diphenyl dimethyl polysiloxane)

• Application-specific columns for residual solvents in pharmaceutical products.

• Analytical column with Integra-Guard® guard column eliminates connecting

problems and leaks.

• Rtx®-G27 stable to 290 °C.

Some methods require the use of a guard column. Our Integra-Guard® integrated

guard column system makes it easy to comply.

Rtx®-G43 Column

(fused silica with 5-meter Integra-Guard® guard column)

(Crossbond® cyanopropylmethyl phenylmethyl polysiloxane)

• Application-specific columns for residual solvents in pharmaceutical products.

Meet all requirements of USP <467>.

• Analytical column with Integra-Guard® guard column eliminates connecting

problems and leaks.

• Rtx®-G43 stable to 240 °C.

Some USP <467> methods require the use of a guard column. Our Integra-Guard®

integrated guard column system makes it easy to comply.

Organic Volatile Impurities (OVI) Analysis

Download y

our free copies from

A Technical Guide for

Static Head

space

Analysis

Using GC

lit. cat.#

59895B

free literature

Custom Re

sidual

Solvents

Mixes

lit. cat.#

PHTS1212

www.restek.com

30-Meter with 5-Meter, 0.53mm ID Integra-Guard Guard Column

ID

df

temp. limits

cat.#

price

0.53 mm 5.00 µm -60 to 270/290 °C

10279-126

30-Meter with 5-Meter, 0.53mm ID Integra-Guard Guard Column

ID

df

temp. limits

cat.#

price

0.53 mm 3.00 µm

-20 to 240 °C

16085-126

0

10

20

1

2

3

4

5

Time (min)

USP <467> Residual Solvents on Rtx®-1301 (G43) by Static Headspace

GC_PH00810

Column

Rtx®-1301 w/5 m Integra-Guard®, 30 m, 0.53 mm ID, 3.00 µm

(cat.# 16085-126)

Sample

USP <467> calibration mixture #5 (cat.# 36007)

Diluent:

DMSO

Conc.:

To each 22 mL headspace vial 5ml water, ~ 1.0 g of sodium

sulfate and 100 µL of stock standard were added.

Injection

headspace-loop split (split ratio 2:1)

Headspace-Loop

Inj. Port Temp.:

180 °C

Instrument:

Teledyne Tekmar HT3

Inj. Time:

1.0 min

Transfer Line Temp.:

150 °C

Valve Oven Temp.:

150 °C

Standby flow rate:

10 mL/min

Sample Temp.:

80 °C

Platen temp equil. time:

2.0 min

Sample Equil. Time:

15.0 min

Mixer time:

2.0 min

Mixing level:

5

Mixer stabilize time:

0.5 min

Vial Pressure:

15 psi

Pressurize Time:

2.0 min

Pressure Equilibration Time: 0.5 min

Loop Pressure:

5 psi

Loop Fill Time:

2.0 min

Loop fill equil. time:

0.5 min

Oven

Oven Temp.:

40 °C (hold 20 min) to 240 °C at 25 °C/min (hold 10 min)

Carrier Gas

He, constant flow

Flow Rate:

5 mL/min

Detector

FID@ 250 °C

Make-up Gas Flow Rate:

45 mL/min

Notes

FID conditions:

hydrogen flow: 40 mL/min

air flow: 450 mL/min

Peaks

t

R

(min)

Conc. (µg/mL)

1. Dichloromethane

5.110

12.0

2. Chloroform

9.285

1.2

3. Benzene

11.173

0.04

4. Trichloroethylene

14.647

1.6

5. 1,4-Dioxane

17.436

7.6