What a laboratory knows about the material it receives
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.
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 Germany has issued a warning on falsified liraglutide 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 24 certificates supplied by the reseller against the laboratory’s public archive matched 3 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 24 certificates supplied by the reseller against the laboratory’s public archive matched 3 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.
Sinéad Corrigan, patient advocate and former trial participant, 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."
The Journal has referred the cloned document to the laboratory named on it and has asked all four independent services whether they will offer a public report-number lookup. Two have replied.
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.
The Journal has read several hundred certificates from twenty companies. We set out what the documents actually cover, and what a reader is filling in from imagination.
A reminder that a purity figure is the output of a method, and that methods differ.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Reported from the analysis, not from a warning notice.
The route did not close because of a rule about peptides.