Reading a certificate as a document rather than as a score
The header identifies the batch, the table records the tests, and the footer says who is answerable. Two of the three are usually incomplete.
Purity
Page 23 of 51 of this archive, newest first.
GL Biochem declines, for the 17th time, to name its synthesis house
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Independent analysis puts a MKM dulaglutide lot at 99.2%, against 96.7% on the certificate
The report states the gradient, the wavelength and the integration threshold, which is more than most.
Independent analysis puts a SGN orforglipron lot at 96.1%, against 93.2% on the certificate
The result is unremarkable. What the report omits is not.
GGPeps declines, for the 15th time, to name its synthesis house
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
What we asked twenty suppliers about stability data
A retest date says that material should be re-examined before use. An expiry date says it should not be used. The trade uses the second word for the first concept.
Deamidation, oxidation, and the two shifts worth memorising
What would be needed to catch each of these, and what it would cost.
VendorInvestigate result on a Shanghai mazdutide lot lands 2.8 points below the supplier’s figure
The supplier has not disputed the finding. It has not explained the gap either.
What changed at FGP in June, and what the company will not say about it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Twenty-eight days is a number from somebody else’s product
Every degradation pathway accelerates by orders of magnitude on reconstitution, because the solvent that lyophilisation removed is the reagent most of them need.
Holograms, QR codes and other things that are not verification
Reported from the analysis, not from a warning notice.
What changed at KP in May, and what the company will not say about it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
A vial can be 99.4 per cent pure and not sterile in the same afternoon
The Journal has read several hundred certificates from twenty companies. We set out what the documents actually cover, and what a reader is filling in from imagination.
Endotoxin is not a microorganism, and killing the bacteria does not remove it
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.
Check the vial, not the box
What happens to traceability when bulk material is subdivided, repackaged and relabelled two or three times before sale.
Custody, condition and the temperature nobody logged
The condition on arrival is recorded by some services and not others, and it is one of the more informative lines in a report.
One measurement, twenty companies, forty compounds
The Journal has read several hundred certificates from twenty companies. The number is almost always there; the method behind it almost never is.
Holograms, QR codes and other things that are not verification
Reported from the analysis, not from a warning notice.
The column is a choice, and it is not a small one
We set out the parameters a method disclosure would contain, all of which are known to whoever ran the sample and none of which is commercially sensitive.
What changed at SGN in May, and what the company will not say about it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.