Sterility testing per USP <71> — need advice

pete_manc_UK 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.

sarah_TO said:

I have a certificate reporting 99.2% purity and 6.1mg content on a vial sold as 5mg, and I cannot work out whether those two numbers are consistent or…

HPLC results interpretation for certificates of analysis: when you get your Janoshik report back, here's what the numbers mean:

• Purity %: Should be >97%. Below 95% is concerning.
• Retention time: Should match reference standard for the peptide
• Related substances: Degradation products should be <2% total
• Single impurity: No individual impurity should exceed 1%

My last batch: 99.6% purity, 0.0% total related substances. Clean chromatogram with single sharp peak at expected retention time. Exactly what you want to see.

BenResearch_OR said:

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

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: 16.6 minutes (consistent with semaglutide reference standard)
Peak purity: 98.5%
Related substances: 0.6% (single impurity at 10.0 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.

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?

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.