FDA_TrackerJim said:The pattern that distinguishes a bad batch from an exit is behaviour rather than product.
I disagree that testing history is decisive. It tells you what a supplier did when they were being watched. Continuity of behaviour under stress — a late shipment, a failed test, a complaint — is more predictive than any run of good results.
The figures, for anyone assembling their own picture. The four things to check on any report, in order: does it name your batch, who commissioned it, what method was used, and does it report content as well as purity. A report failing any of those is weak evidence regardless of the percentage on it.
Dr.AddMedPHL said:I disagree that testing history is decisive.
There is a second half to this that has not been said yet. They are not contradictory, they measure different things, and this is the single most common misreading of a certificate. Purity is a relative area measurement: the main peak as a percentage of total peak area in the chromatogram. Content is an absolute mass measurement against a reference standard. A vial can be 99% pure and contain 6.1mg — pure material, overfilled — or 99% pure and contain 3mg, which is pure material and a short fill. Purity tells you what fraction of what is there is the right molecule; content tells you how much of it there is. You need both, and a certificate with only purity is telling you half the story.
I would rather be corrected than agreed with, if it comes to it.
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Shop Reference StandardsA narrower follow-up, since the general answer is now clear:
How people are distinguishing a supplier having a bad batch from a supplier on the way out?
Reporting back.
Went back through my own correspondence with an earlier supplier and the warning signs were all there in the replies, weeks before the quality changed. I was reading the product and not the behaviour.