System suitability - peptide mapping
Posted: Fri Jan 04, 2013 2:13 pm
by biochemist
Can anyone share their system suitability criteria for peptide mapping for routine QC analysis?
E.g. x injections, peak A NMT than y% RSD area, etc....
Re: System suitability - peptide mapping
Posted: Tue Jan 15, 2013 6:28 pm
by dorota
This is from EP 5.0:
System suitability :
— the chromatograms obtained with the test solution
and the reference solution are qualitatively similar to
the chromatogram of human insulin digest supplied
with human insulin CRS,
— in the chromatogram obtained with the reference
solution, identify the peaks due to digest fragments I,
II and III :
symmetry factor: maximum 1.5 for the peaks due to
fragments II and III,
resolution: minimum 3.4 between the peaks due to
fragments II and III.