Microsoft word - indomethacin degrad.doc

thermal degradation study highlights the expressLC™
system’s throughput and selectivity
introduction
application note
Whether it is degradation studies to challenge the specificity of a drug substance or drug product assay, analysis of toxicological dosing solutions, or long term stability studies (LTSS)-the number accelerated thermal degradation
of samples can be overwhelming. For specificity and LTSS of indomethacin drug product
studies, selectivity is a crucial aspect of analysis: low level impurities need to be detected before they become regulatory issues. The high throughput and excellent selectivity of the ExpressLC systems is expressly designed to address these time and resource intensive activities. Do you need to re-inject some samples due to instrumental failure during a long instrumental run? The ExpressLC system can make several injections with the sample volume required for one conventional LC analysis. No more embarrassing “insufficient sample for analysis” data entries. ExpressLC systems transform routine analyses into consistent, high-quality data. figure 1. chromatogram of thermally-degraded indomethacin figure 2. experimental conditions and area percent table Mobile phase: A/B water/acetonitrile with 0.1% TFA Flow rate: species peak
expressLC system specifications

configuration

expressLC-100 Single-channel System: Includes binary gradient
eksigent technologies
pump, electronic injection valve, column temperature control, and array- based UV detection system. Optional high-speed autosampler available. expressLC-800 8-channel Parallel System: Includes 8 binary gradient
pumps, 8 electronic injection valves, 8 column temperature control compartments, an array-based UV detection system and high-throughput new jersey office/laboratory
flow rate range
pump type
Microfluidic direct pumping system with independent flow control feedback for each mobile phase. Retention time RSD < 0.5%. gradient formation
High pressure gradient mixing. System can run full gradients as rapidly as 8 seconds. Maximum gradient length 2 hrs. at 5 µL/min.
delay volume
mobile phase compatibility
All mobile phases compatible with 316 stainless steel, PEEK, and silica.
injection valve
Eksigent Variable-Volume Injection System (software selectable). Standard injection volume 10–250 nL (larger injection volumes available).

columns
System optimized for 2.5–15 cm, 300 µm i.d. capillary LC columns

column temperature control
Software selectable from 27–40°C; stability within ± 0.1°C

detection
UV absorbance detection from 200–380 nm using linear CCD array
detector. Detector drift ≤ 4 x 10-4 AU/hr Non-linearity ≤ 5% @ 2 AU.

flow cell
45 nL microfabricated flow cell with integral fiber optics, 4 mm path length

autosampler
High-throughput CTC autosampler available

system control
Computer with graphical user interface for control of all system parameters.
Software allows import of run tables and creates CDF, text, and Excel files
for data export and analysis. Tracking of instrument runtime, column usage,
total injections, solvent usage, lamp hours, and error codes. System drivers
available for Thermo Electron’s Xcalibur and Applied Biosystems/MDS
SCIEX Analyst 1.4.1 mass spectrometer software.

report features
Generates reports that include method conditions, chromatograms, peak
retention times and areas, and spectral absorbance map.

dimensions
expressLC-100 System:
21" (53 cm) wide, 20" (51 cm) deep, 18" (46 cm) high
expressLC-100 Autosampler:
Additional 14" (36 cm) high and 6" (15 cm) wide
expressLC-800 System:
30" (76 cm) wide, 34" (86 cm) deep, 40" (102 cm) high
expressLC-800 Autosampler:
Additional 16" (41 cm) high and 16" (41 cm) wide
computer
Additional lab space needed for keyboard, mouse and monitor
2005 Eksigent Technologies. All rights reserved. Information subject to change without notice.
Eksigent is a registered trademark and ExpressLC is a trademark of Eksigent Technologies. All
other trademarks are the property of their respective owners. Printed in the USA. AN-405-X03

Source: http://eksigent.webenomic.com/pdf/ExpLC_Thermal_AN.pdf

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