Holograms, QR codes and other things that are not verification
Reported from the analysis, not from a warning notice.
Certificates of analysis
Page 44 of 51 of this archive, newest first.
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.
Independent analysis puts a WXT semaglutide lot at 98.8%, against 95.3% on the certificate
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
The anatomy of the most reproduced page in this trade
Nothing on this page is difficult. It is simply unfamiliar, and unfamiliarity is what makes a weak certificate look like a strong one.
VendorInvestigate result on a Zhuhai dulaglutide lot lands 2.6 points below the supplier’s figure
A reminder that a purity figure is the output of a method, and that methods differ.
Independent analysis puts a QST cagrilintide lot at 98.4%, against 96.0% on the certificate
The supplier has not disputed the finding. It has not explained the gap either.
What we are not saying about anybody in this trade
None of what this piece asks for is commercially sensitive, and all of it is already known to whoever released the batch.
Quadrupole, time-of-flight, orbital trap: what each class can and cannot see
Parts per million sound impressive until they are converted into daltons at the molecular weight of the thing being measured.
Quadrupole, time-of-flight, orbital trap: what each class can and cannot see
Every instrument specification quoted in an advertisement is a best case obtained on a calibration mixture, not on a submitted vial.
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.
Why a dead-clean sterile filter can pass pyrogen straight through
The masking phenomenon known as low endotoxin recovery means a formulation can return a clean result while containing endotoxin the assay cannot see.
PeptideMeter result on a Guangzhou orforglipron lot lands 3.3 points below the supplier’s figure
A reminder that a purity figure is the output of a method, and that methods differ.
What changed at HJ 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.
The badge economy, and what it is actually certifying
What a verification mark would have to carry to be checkable: a date, a lot, a method, a submitter and a link to the report.
Portugal health authority warns on falsified liraglutide pens
Reported from the analysis, not from a warning notice.
What a laboratory knows about the material it receives
Chain of custody, in a regulated setting, begins at sampling. Here it begins when the package arrives.
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.
Who signed this, and what did they undertake by signing it
Two signatures — one who performed the work, one who approved its release — are the ordinary regulated convention and are almost unknown here.
How to audit an identity claim in five minutes
The regulated world states the method, the instrument, the convention and the tolerance. This market states a verdict.