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System suitability - peptide mapping

Discussions about HPLC, CE, TLC, SFC, and other "liquid phase" separation techniques.

2 posts Page 1 of 1
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....
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.
2 posts Page 1 of 1

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