What changed at SGN in October, and what the company will not say about it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
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 Sweden 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 15 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 15 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.
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.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
The observation that closes a facility is rarely the dramatic one.
Residual moisture is measured routinely in regulated manufacture, is reported almost nowhere in this trade, and predicts long-term stability better than any other single…
A reader holding a certificate can work out what it does not cover in about ninety seconds, and that is a useful ninety seconds.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
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.