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.
Certificates of analysis
Page 24 of 51 of this archive, newest first.
Holograms, QR codes and other things that are not verification
Reported from the analysis, not from a warning notice.
Independent analysis puts a TFC semaglutide lot at 97.6%, against 95.9% on the certificate
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
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.
Six words a verification badge would need to mean anything
A badge asserts that something was tested. It does not assert what, when, on whose sample, by what method, or whether the lot on sale is the lot that was tested.
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.
Medutest result on a Qingdao survodutide lot lands 2.7 points below the supplier’s figure
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
The sample is not the batch
A result on one vial generalises to a batch only if the vial was drawn in a way that makes it representative — and nobody records how it was drawn.
The instrument was calibrated on Tuesday. Your sample ran on Friday.
Parts per million sound impressive until they are converted into daltons at the molecular weight of the thing being measured.
What changed at MKM 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.
VendorInvestigate result on a Xianning cagrilintide lot lands 2.6 points below the supplier’s figure
The result is unremarkable. What the report omits is not.
The impurity hiding underneath the parent peak
Where two methods disagree, the conservative convention is to report the lower figure. It is not universal, and whether a laboratory follows it belongs on the report.
Independent analysis puts a Homopeptide retatrutide lot at 98.9%, against 98.1% on the certificate
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
Nought point nine eight of a dalton: the modification that hides in plain sight
Stereochemical inversion changes the molecule, changes its biology, and changes its mass by exactly nothing.
Spain health authority warns on falsified tirzepatide pens
Reported from the analysis, not from a warning notice.
Change the pH and the co-elution moves
An orthogonal method separates on a different physical principle, so that species co-eluting in the first are likely to resolve in the second. Two runs of the same method at…
Independent analysis puts a ERP survodutide lot at 96.4%, against 93.7% on the certificate
The supplier has not disputed the finding. It has not explained the gap either.
Six words a verification badge would need to mean anything
The Journal does not treat a badge as evidence and states so wherever it reports one.
Holograms, QR codes and other things that are not verification
Reported from the analysis, not from a warning notice.