Particulate matter testing — USP <788> for injectable peptides

traveltech_sara said:

They are not contradictory, they measure different things, and this is the single most common misreading of a certificate.

Saving this. It is the first explanation that did not require me to already understand it. Taking it to my next appointment.

Adding the clinical framing, because it changes how the question reads.

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.

Dr.NephBHM_UK 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…

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

• Janoshik: Gold standard for peptide community, ~$130, 10-14 day turnaround
• Valitech: US-based, ISO 17025 accredited, ~$230
• Eurofins: Full pharmaceutical testing suite, more expensive but comprehensive
• ChemTox: Basic identity and purity testing, ~$120

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.

CarlaRPh_TPA said:

The provenance questions are more useful than the numbers.

Community-verified vendors for certificates of analysis: I maintain a spreadsheet of Janoshik-verified test results submitted by community members. Across 62 submitted tests:

• 82% tested at ≥98% purity
• 12% tested at 95-98% purity
• 6% tested at <95% purity (concerning)

The vendors with consistently high purity results are listed in the Vendor Directory. We update monthly based on new community submissions.

Moderator note: leaving this open. It is being argued well and the disagreement is the useful part.