Waters Preparative Chromatography Mix Standard - Manual (Page 4)

[ CARE AND USE MANUAL ]
Preparative Chromatography Mix 4
Figure 2: Retention Time Control Chart
The establishment of control limits provides data as to the current
capabilities of the system. Control charting allows the quality
professional to compare instrument performance to the required
method specifications.
The process of continuous quality improvement can also be tracked
using control charts. When improvements are made to a method,
control charts allow you to see that the changes you have made are
effective and having the desired impact. The control chart will also
allow you to track trends over time. By observing the data trending
higher or lower over time, you can take preventative action prior to
having an out of specification result.
Control charting can be employed for each QCRM criteria; peak
retention time, peak area, peak width, and peak resolution. Control
charts allow quality control professionals to establish statistically
significant criteria to monitor and control their HPLC analyses
thereby avoiding criteria that are too stringent or set arbitrarily.
Summary
The use of high quality reference standards specifically designed for
the system analysis, provide a controlled, consistent, and reliable
measure of system performance. Regular use of reference standards
and control charting the data provides improved monitoring of system
performance and system robustness, while at the same time
providing assurance that any results produced are high quality,
reliable, and reproducible.
References
1) Taylor, J.K., “Quality Assurance of Chemical Measurements”, Lewis Publishers, 1987
2) Smith, G.M., “Statistical Process Control and Quality Improvement”, 3rd edition,
Prentice Hall, 1998
3) Ahuja, S. and Dong, M.W., “Handbook of Pharmaceutical Analysis by HPLC”, Elsevier
Inc., 2005
V. TROUBLESHOOTING:
The Preparative Chromatography Standard contains an acidic, basic
and neutral compound. Due to the vastly different properties of
stationary phases, not all compounds will behave similarly on each
column. For instance, basic compounds often have poor peak
shape on reversed-phase columns at neutral pH due to increased
interactions between the charged bases and silanols on the surface
of the stationary phase. For this reason, it is very important to
benchmark the performance of the Preparative Chromatography
Standard on a new column and functioning system. This will help
to identify whether poor peak shape issues are due to compound
interactions on the column, or failing column/system performance.
Failure to meet QCRM criteria will result in the need to troubleshoot
the system. Some chromatographic issues may be easily resolved,
for instance, a missing peak may simply be due to co-elution of
two peaks. However, most issues such as poor peaks shape, tailing
peaks, retention time shifts and poor peak response, to name a few,
may be due to a variety of causes that can be difficult to pinpoint.
For a detailed and comprehensive guide to troubleshooting, please
refer to the HPLC Troubleshooting Guide (WA20769) on the
Waters website.
VI. ORDERING INFORMATION
Description Part Number
Preparative/Purification Chromatography
Mix Standard
186006703
Thank you for choosing a QCRM from Waters. The standards are
manufactured in our ISO 9001 ISO 17025 facility. Each standard
is manufactured to ensure optimal reproducibility from lot to lot. A
Waters QCRM can be depended on for its’ accuracy. This removes
one variable from your system variability and provides you the most
dependable starting point for your testing.
If the QCRM box shows significant damage, notify the carrier and
your supplier at once and retain evidence of shipping damage so that
a claim can be made.
Time
(min)
Flow
(mL/min)
%A %B Curve
1 Initial 25.00 95.0 5.0 Initial
2 0.10 25.00 95.0 5.0 6
3 6.10 25.00 5.0 95.0 6
4 7.10 25.00 5.0 95.0 6
5 7.20 25.00 95.0 5.0 6
6 10.10 25.00 95.0 5.0 6
A = 0.1% TFA in water
B = 0.1% TFA in acentonitrile