Set the threshold at a tenth of a per cent and the small impurities vanish
We work through a single chromatogram twice, under two integration conventions, and show where the difference comes from.
Janoshik Analytical
The Czech testing laboratory whose reports circulate most widely in this market.
Same material, different gradients, different answers
Duplicate submissions under different names test within-laboratory repeatability, which is a different quantity from between-laboratory reproducibility.
What a split-sample exercise can establish, and what it cannot
Duplicate submissions under different names test within-laboratory repeatability, which is a different quantity from between-laboratory reproducibility.
The badge is about a sample. The listing is about a product.
The Journal does not treat a badge as evidence and states so wherever it reports one.
How a claim degrades between the bench and the listing
A badge asserts that something was tested. It does not assert what, when, on whose sample, by what method, or whether the lot on sale is the lot that was tested.
A purity figure is a numerator over a denominator, and both are choices
Regulated pharmaceutical practice has explicit reporting, identification and qualification thresholds. This trade has none, which is why a purity figure carries no…
Six words a verification badge would need to mean anything
What a verification mark would have to carry to be checkable: a date, a lot, a method, a submitter and a link to the report.
Peak capacity, and the honest measure of a separation
Gradient slope is the single most consequential method parameter for a reported purity figure, and it is the one most often omitted.
What orthogonal actually means, and what it does not
Aggregates dissociate in the mobile phase and are recorded as monomer. Only a size-based separation reports them.
Six words a verification badge would need to mean anything
A badge asserts that something was tested. It does not assert what, when, on whose sample, by what method, or whether the lot on sale is the lot that was tested.
Five things a purity figure cannot tell you
An orthogonal method separates on a different physical principle, so that species co-eluting in the first are likely to resolve in the second. Two runs of the same method at…
The badge economy, and what it is actually certifying
Every step between the laboratory report and the product page removes information, and the badge is the last step.
The named comparison we promised two years ago
Duplicate submissions under different names test within-laboratory repeatability, which is a different quantity from between-laboratory reproducibility.
What a diode array adds, and why the certificate never shows it
Non-chromophoric components — counter-ions, salts, some excipients — contribute mass to the vial and nothing at all to the chromatogram.
The named comparison we promised two years ago
The Journal submitted split samples from single lots to three assay services, under names unconnected to this publication, and published each method alongside each result.
Same material, different gradients, different answers
The Journal submitted split samples from single lots to three assay services, under names unconnected to this publication, and published each method alongside each result.
The submitted sample: the weakest link in the whole system
Every third-party report in this market describes a sample somebody chose to send. That choice is outside the laboratory’s control and outside its records.
From vial to bench: what is recorded and what is assumed
A result on one vial generalises to a batch only if the vial was drawn in a way that makes it representative — and nobody records how it was drawn.
Custody, condition and the temperature nobody logged
The condition on arrival is recorded by some services and not others, and it is one of the more informative lines in a report.
An interlaboratory comparison nobody had run
Duplicate submissions under different names test within-laboratory repeatability, which is a different quantity from between-laboratory reproducibility.