How to commission independent testing — need advice

Taking the question as asked, rather than the general version of it. The provenance questions are more useful than the numbers. Does the report name the batch on your vial. Is the date consistent with when that batch existed. Is it addressed to the vendor or to the person who paid for the test. Was the sample taken from general stock or supplied by the vendor. A perfect certificate for a different batch is worth nothing, and vendor-supplied samples are the most common way a genuine report ends up misleading.

Correct me if the detail matters more than I have assumed.

CarlaRPh_TPA said:

The provenance questions are more useful than the numbers.

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.

Ask again with the specifics and you will get a better answer than this one.

jennifer_SEA said:

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

Same position here, arrived at the long way round. Inter-laboratory variation comes from real methodological differences, not sloppiness: which reference standard was used and how it was itself calibrated, the gradient and column, the detection wavelength, and where the integration baseline was drawn. A percentage point or two between competent labs is expected. What is not expected is a large gap, and the usual explanation there is that one report is not of the batch in your hand.

From the other side of the consultation, briefly.

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: 99.7% purity, 0.3% total related substances. Clean chromatogram with single sharp peak at expected retention time. Exactly what you want to see.