The arithmetic behind every identity confirmation, worked in full
A peptide has a monoisotopic mass and an average mass, they differ by several daltons at this molecular size, and a certificate that does not say which it quotes cannot be…
Independent testing
Page 17 of 27 of this archive, newest first.
Why a dead-clean sterile filter can pass pyrogen straight through
The limit for a parenteral product is calculable from the dose and the body weight in two lines. Almost nobody in this trade performs the calculation.
The pyrogen question has a price, and it is not the price of a purity run
Endotoxin is the more tractable of the two questions, and a kinetic chromogenic determination is neither slow nor exotic. It is simply not on the menu.
The specification sheet says 500,000. The report says conforms.
Every instrument specification quoted in an advertisement is a best case obtained on a calibration mixture, not on a submitted vial.
Reading a certificate for what it does not say
The most consequential features of most certificates in this market are the tests that do not appear on them at all.
Independent analysis puts a SGN survodutide lot at 97.0%, against 92.8% on the certificate
A reminder that a purity figure is the output of a method, and that methods differ.
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.
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.
VendorInvestigate result on a Shanghai dulaglutide lot lands 2.0 points below the supplier’s figure
The result is unremarkable. What the report omits is not.
Independent analysis puts a QST exenatide lot at 98.4%, against 95.6% on the certificate
A reminder that a purity figure is the output of a method, and that methods differ.
Independent analysis puts a HJ tirzepatide lot at 97.3%, against 94.2% on the certificate
The supplier has not disputed the finding. It has not explained the gap either.
How a claim degrades between the bench and the listing
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.
A tested vial is evidence about a vial
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.
We asked four laboratories for a sterility test. Here is what came back.
The absence of microbiological capability in this market is a commercial fact with a straightforward explanation, and it is worth understanding before blaming anybody for it.
VendorInvestigate result on a Chengdu cagrilintide lot lands 3.1 points below the supplier’s figure
A reminder that a purity figure is the output of a method, and that methods differ.
What changed after we published the first version of this
A reader holding a certificate can work out what it does not cover in about ninety seconds, and that is a useful ninety seconds.
LAL, kinetic chromogenic, recombinant factor C: three ways to the same figure
The limit for a parenteral product is calculable from the dose and the body weight in two lines. Almost nobody in this trade performs the calculation.
Janoshik result on a Xianning semaglutide lot lands 4.3 points below the supplier’s figure
The supplier has not disputed the finding. It has not explained the gap either.
Check the vial, not the box
A document is only as good as the chain that connects it to the material, and most chains here are two or three links longer than the paperwork admits.
Two documents, two disciplines: purity and sterility are not the same trade
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.