Batch-to-batch purity variation — acceptable ranges

kate.chem said:

The provenance questions are more useful than the numbers.

Reconstituted peptide stability data for certificates of analysis: I had Janoshik test my reconstituted vial at day 1, day 14, and day 28 stored in the refrigerator.

Day 1: 99.2% purity
Day 14: 98.5% purity
Day 28: 99.2% purity

Minimal degradation over 28 days when properly refrigerated. This confirms the standard 28-day beyond-use date is appropriate. Beyond 28 days, I'd reconstitute a fresh vial to be safe.

One thing that is still open after james_edin’s answer:

Whether a purity figure and a content figure can disagree without one of them being wrong?

josh_phd_bmore said:

Reconstituted peptide stability data for certificates of analysis: I had Janoshik test my reconstituted vial at day 1, day 14, and day 28 stored in…

Mass spectrometry confirmation for certificates of analysis: beyond HPLC purity, mass spec tells you the molecule's exact molecular weight. This confirms identity — not just purity.

Why this matters: HPLC can show you a "pure" compound, but if it's pure of the WRONG compound, purity is meaningless. Mass spec at m/z 4113.58 Da confirms it's actually semaglutide. My Janoshik report includes both HPLC and mass spec.

If your testing provider only offers HPLC, consider upgrading to include mass spec for at least your first batch from a new vendor.

OP back with an update, since a thread like this is useless without one.

Purity and content being different measurements was the piece I was missing. The vial was overfilled and pure, which is a very different problem from the one I thought I had.

GenomicsKate said:

Mass spectrometry confirmation for certificates of analysis: beyond HPLC purity, mass spec tells you the molecule's exact molecular weight.

Agreeing with GenomicsKate, and the qualification matters more than the agreement. One addition: an unstated method makes a report close to uninterpretable. "99% pure" without the technique, the standard and the conditions is a claim, not a measurement.