Low endotoxin recovery: the interference nobody looks for
We submitted vials for endotoxin determination and report the results, the method and the laboratory, because a pyrogen figure without a method is as empty as a purity…
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
The Supply Chain Dispatch
Reported from the analysis, not from a warning notice.
The health authority in New Zealand has issued a warning on falsified tirzepatide injection pens found in the legitimate supply chain. The Journal has reviewed the notice and the accompanying photographs; the distinguishing features are a batch-number font difference and a needle-shield colour, neither of which a patient could reasonably be expected to detect.
Comparison of 8 certificates supplied by the reseller against the laboratory’s public archive matched 4 of them to reports commissioned by other parties, in some cases more than a year earlier. The reseller did not respond to two written requests for comment.
Comparison of 8 certificates supplied by the reseller against the laboratory’s public archive matched 4 of them to reports commissioned by other parties, in some cases more than a year earlier. The reseller did not respond to two written requests for comment.
The document is the weakest link in this trade. A certificate is a PDF; a laboratory letterhead is an image; a lot number is a string. Nothing in the ordinary transaction allows a buyer to confirm that a given report was issued for a given vial, and the four independent services differ in whether they offer any lookup at all.
Rowena Ashcombe, community pharmacist and diabetes educator, said the underfill finding was the more consequential one. "Nobody is being poisoned by a low content figure. Everybody using that vial is out by a fifth in every calculation they make."
Readers holding a certificate they cannot verify can send it to the standards desk. We compare against archives where they exist and publish the aggregate.
We submitted vials for endotoxin determination and report the results, the method and the laboratory, because a pyrogen figure without a method is as empty as a purity…
Reported from the analysis, not from a warning notice.
Regulated pharmaceutical practice has explicit reporting, identification and qualification thresholds. This trade has none, which is why a purity figure carries no…
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 route did not close because of a rule about peptides.
The condition on arrival is recorded by some services and not others, and it is one of the more informative lines in a report.