Download Developing a Guided Procedure for Troubleshooting HPLC and

ooting solution is
phic
es run with
lected reference
s electronic
ystem within a
preprogrammed
tion of the
Electronic
ware tools
ng solution.
area of the 25% for impurity B (Figure 3, Peak 1, bottom)
compared to the in spec result of 0.03%.
FIGURE 3. Out-of-spec result in impurity analysis.
1.6
AU
2
1
1
0
0.9 AU
3
In spec result
2
3
4
4
min
Out-of spec result
2
1
00 RS system
PG-3400RS,
tat TCC-3000RS
Solution (PN
mn (Thermo
m, 4 m , PN
XPert gradient
0
min
0.5
0.25
0
The interpretation of the result is performed according to the
methodical troubleshooting workflow of Fig. 4.
FIGURE 4. Troubleshooting workflow.
Install XPert
column, load
standards and
eWorkflow, mobile
phase
(U)HPLC results
questionable
e package SR1.
Run isocratic or
gradient method =>
immediately review
tips in report
Test fails
Test passes
Review all details of XPert report
applying system and system
setup troubleshooting,
rerun XPert, if recommended:
perform maintenance or repair
Run XPert standards with
original column, modify
method accordingly (method
transfer tools)
/v)
rate
min 95% B, 4.5–
Test fails
Initiate
Instrument
Service
rate
ogram.
5
ogram.
8
9
4.0
min
4.5
Test passes
Perform validation
or SST according
to your SOPs,
rerun XPert to
benchmark
application &
system
Test fails
Replace
column
min
4.0
After replacing the colu
the operability of the co
The interpretation of the
impurity can be assess
Step IV – Performance
Long term monitoring o
indicators is implement
periodically running the
column allowing an ear
done without exporting
settings of the XPert Tr
FIGURE 8. Using Chro
functionality for perfo
Test passes
Investigate
application and
verify sample
or standard
preparation
Step I – System Check: First the isocratic test mix is
separated on the reference column by easy method
installation using the eWorkflow. The results are immediately
assed by an report, showing that the system is in an operable
status( Fig. 5)
FIGURE 5. Automatically evaluated parameters show
operable system.
10
Step III – Replacing th
Conclusion an
• A standardized check
reference test mixture
chromatographic para
troubleshooting indepe
• Automatically evaluat
provide helpful indica
suggested actions to
simplified for LC begi
knowledge and practi
while making the use
and introducing perfo
intervention if things g
Thermo Scientific Poster Note • PN71313-ISC-EN 0914S 5
• The XPert troublesho