Sterility testing per USP <71> — need advice

Dr.BariatricHTX said:

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

I am more sceptical of certificates as a category than this thread is. The document tells you about a sample somebody chose to send, at a moment in time, and nothing about the vial in your hand. Independent purchase-and-test is a different quality of evidence and everything else is inference.

Dr.RaviCardio said:

Two reports on the same product from two laboratories, four percentage points apart, and no method stated on either.

My HPLC chromatogram analysis for certificates of analysis — I sent my batch to Janoshik and here's what the results showed:

Main peak retention time: 16.3 minutes (consistent with semaglutide reference standard)
Peak purity: 98.5%
Related substances: 0.7% (single impurity at 10.2 minutes — likely a synthesis intermediate)
Mass spec: m/z 4113.5 (matches expected molecular weight)

This is a clean result. The mass spec confirmation is particularly important — it proves the molecule is actually semaglutide and not a substitution.

SarahChen_PharmD said:

I am more sceptical of certificates as a category than this thread is.

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

• Janoshik: Gold standard for peptide community, ~$153, 10-14 day turnaround
• Valitech: US-based, ISO 17025 accredited, ~$203
• Eurofins: Full pharmaceutical testing suite, more expensive but comprehensive
• ChemTox: Basic identity and purity testing, ~$113

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.

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

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

Reporting back.

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.