The Column - December 2006 - (Page 14)
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/mnt/data/www.nxtbook.com/fx/config_1.3/global.php on line 10 McBrien and
Antler The Column www.thecolumn.eu.com December 2006 Systematic
Development of Stability-Indicating Methods Michael McBrien and Margaret
Antler, Advanced Chemistry Development Inc. ACD/Labs , Toronto, Canada.
This article discusses some of the benefits and challenges associated with
maintaining individual degradation samples for LC–MS-UV method
development. The latest advancements for automated data interpretation,
including automated LC–MS and LC-UV peak tracking and detector
reconciliation, are described. These advancements allow a virtual
composite sample to be created post data acquisition and transferred to LC
optimization software for systematic, efficient method development.
Chromatographic method development can be a challenging process. There is
a practically unlimited number of chromatographic conditions that may be
considered in designing an effective technique for quantifying impurities
in a given sample. A hit-or-miss approach can be used when chromatographic
samples are very simple or when analysis will not be performed enough times
to reward excellent method design. A more rigorous, scientific approach is
appropriate for complex problems or for design of robust methods that will
be applied thousands of times. Modern pharmaceutical practices require
quantification of impurities at levels of 0.05–0.1% of the active
compound. This Authors: Michael McBrien and Margaret Antler E-mail:
Michael.mcbrien@acdlabs.com 14 Margaret.antler@acdlabs.com Warning : Unknown : The session id contains invalid characters, valid
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http://www.thecolumn.eu.com
Table of Contents for the Digital Edition of The Column - December 2006
Contents
News
Opinion
Market Trends and Analysis
Systematic Development of Stability-Indicating Methods
Supplies and Services
SPE Product Directory
The Column - December 2006
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