Italy health authority warns on falsified semaglutide pens
Reported from the analysis, not from a warning notice.
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 South Africa 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 18 certificates supplied by the reseller against the laboratory’s public archive matched 2 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 18 certificates supplied by the reseller against the laboratory’s public archive matched 2 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."
Our series on identity confirmation covers the analytical detection of substitution in detail, including the mass differences that correspond to the commonest related compounds.
Reported from the analysis, not from a warning notice.
Three compendial method families are in routine use and a fourth, based on a recombinant enzyme rather than crab lysate, is now compendial in its own right.
Aggregates dissociate in the mobile phase and are recorded as monomer. Only a size-based separation reports them.
The Journal does not treat a badge as evidence and states so wherever it reports one.
Reported from the analysis, not from a warning notice.
A compendial sterility test takes fourteen days of incubation and consumes the containers tested. That timescale is incompatible with the business model that made…