Moisture content analysis for lyophilized peptides — Karl Fischer method

LarryQC_SD said:

Inter-laboratory variation comes from real methodological differences, not sloppiness: which reference standard was used and how it was itself…

I tested my certificates of analysis batch through Janoshik — 99.2% purity. That's within acceptable range for compounded peptides. Turnaround was 14 business days.

The test costs ~$140 but gives you actual HPLC chromatography data plus mass spec confirmation. For the peace of mind alone, it's worth every penny. I test every new batch from a new vendor.

A narrower follow-up, since the general answer is now clear:

Why two laboratories report different purity for the same batch, and which number to believe?

PeptideChemSF said:

I tested my certificates of analysis batch through Janoshik — 99.2% purity.

Third-party testing services for certificates of analysis besides Janoshik:

• Janoshik: Gold standard for peptide community, ~$158, 10-14 day turnaround
• Valitech: US-based, ISO 17025 accredited, ~$238
• Eurofins: Full pharmaceutical testing suite, more expensive but comprehensive
• ChemTox: Basic identity and purity testing, ~$108

Janoshik is the community standard but any ISO-accredited analytical lab can verify peptide identity and purity. The key is independence — don't rely solely on the vendor's own testing.

Closing the loop on my own question.

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.

jim_asheville said:

Third-party testing services for certificates of analysis besides Janoshik: Janoshik: Gold standard for peptide community, ~$158, 10-14 day turnaround…

Agreed, and mass spec answers a question purity does not: identity. High purity tells you one thing dominates the chromatogram, not that it is the molecule you ordered. A mass within about a dalton of expected is the identity check.