The word “confirmed” is doing an enormous amount of work on this certificate
The Journal’s standing position: a mass that matches is necessary evidence of identity and nowhere near sufficient.
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 the United Kingdom has issued a warning on falsified semaglutide 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 5 certificates supplied by the reseller against the laboratory’s public archive matched 6 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 5 certificates supplied by the reseller against the laboratory’s public archive matched 6 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.
Alastair Renshaw, pharmaceutical supply-chain consultant, 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.
The Journal’s standing position: a mass that matches is necessary evidence of identity and nowhere near sufficient.
An isoaspartate rearrangement changes the molecule and not the mass. A method that confirms identity by molecular weight alone will report it as the parent compound.
The observation that closes a facility is rarely the dramatic one.
Reported from the analysis, not from a warning notice.
The route did not close because of a rule about peptides.
Purity, content, identity, sterility and endotoxin are five separate determinations. A single sheet of paper carrying one of them is not evidence about the other four.