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Hi colleagues,
We are having some problems with our solution (analyte in solvent) stability
studies. The solution stabilities and reproducibility of solution creation
are checked by HPLC-UV. The standard we set is <3% difference between the
solutions made up by two different analysts. We find this difficult to
achieve. Sources of variability include pipetting, weighing errors and
injection variability. I was wondering if any other members on the list had
encountered similar problems? Are there any good papers or books on this
subject? Does anyone have experience of what is required to be shown for
solution stability to comply with GLP/GCP/FDA? Also, is there a better
method to assess solution stability and solution reproducibility.
Thanks for your time
James Hillis BSc. AMRSC
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)