What twenty companies say about storage, and what they have measured
A stability programme needs a protocol, defined conditions, a stability-indicating method and time. Time is the ingredient no commercial testing service can sell.
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 23 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 23 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."
Our series on identity confirmation covers the analytical detection of substitution in detail, including the mass differences that correspond to the commonest related compounds.
A stability programme needs a protocol, defined conditions, a stability-indicating method and time. Time is the ingredient no commercial testing service can sell.
Aggregates dissociate in the mobile phase and are recorded as monomer. Only a size-based separation reports them.
The header identifies the batch, the table records the tests, and the footer says who is answerable. Two of the three are usually incomplete.
Reported from the analysis, not from a warning notice.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.