LAL, kinetic chromogenic, recombinant factor C: three ways to the same figure
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 Turkey has issued a warning on falsified exenatide 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 22 certificates supplied by the reseller against the laboratory’s public archive matched 5 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 22 certificates supplied by the reseller against the laboratory’s public archive matched 5 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.
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…
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Matching a retention time against a standard is evidence of consistency, not proof of identity. Two different species can elute at the same time on one method.
The report states the gradient, the wavelength and the integration threshold, which is more than most.
The sequence predicts the failure mode. A methionine predicts oxidation; an asparagine followed by a glycine predicts deamidation; a cysteine predicts disulphide scrambling.
Follow the resin, not the catalogue.