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Testing & documentation

LC-MS Identity Verification on Peptide Certificates

Mass spectrometry supports identity when an observed value is reported against a calculated mass. “Conforms” without a number is a verdict with the work omitted.

Therapept EditorialUpdated 12 September 20267 min readReviewed by Therapept Editorial

LC-MS answers a different question from HPLC: was a mass consistent with the intended ion observed in this run? A correct mass on a minority peak is still a correct mass.

Minimum to record

  • Calculated mass or formula the lab used.
  • Observed m/z or deconvoluted mass.
  • Charge state if an ion is reported.
  • The spectrum, if the summary is to be checked.

Sources

  1. ICH Q2(R2) — Validation of Analytical Procedures

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