The reviewer, the approver, and why regulated documents carry two names
Somebody has to be answerable for a release document. On most certificates in this market, nobody is named at all.
Independent testing
Page 7 of 27 of this archive, newest first.
VendorInvestigate result on a Xi'an cagrilintide lot lands 0.7 points below the supplier’s figure
The report states the gradient, the wavelength and the integration threshold, which is more than most.
What a split-sample exercise can establish, and what it cannot
The Journal submitted split samples from single lots to three assay services, under names unconnected to this publication, and published each method alongside each result.
The pyrogen question has a price, and it is not the price of a purity run
A compendial sterility test takes fourteen days of incubation and consumes the containers tested. That timescale is incompatible with the business model that made…
The named comparison we promised two years ago
The Journal submitted split samples from single lots to three assay services, under names unconnected to this publication, and published each method alongside each result.
PeptideMeter result on a Zhuhai tirzepatide lot lands 3.5 points below the supplier’s figure
The result is unremarkable. What the report omits is not.
Independent analysis puts a SGN cagrilintide lot at 98.0%, against 96.6% on the certificate
A reminder that a purity figure is the output of a method, and that methods differ.
Independent analysis puts a GL Biochem semaglutide lot at 97.8%, against 94.6% on the certificate
A reminder that a purity figure is the output of a method, and that methods differ.
The wavelength decides which impurities exist
Peptide bonds absorb strongly near 214 nm; aromatic side chains absorb near 280 nm. A method reading at 280 is blind to any fragment lacking an aromatic residue.
Why a 0.036-dalton difference is the hardest number in peptide identity
Calibration drift is real, unremarkable, and the reason serious laboratories run internal standards.
Why a dead-clean sterile filter can pass pyrogen straight through
Bacterial endotoxin is a heat-stable lipopolysaccharide from the outer membrane of Gram-negative organisms. It survives sterilisation, passes a sterilising filter, and is…
Independent analysis puts a FGP mazdutide lot at 98.8%, against 96.2% on the certificate
The report states the gradient, the wavelength and the integration threshold, which is more than most.
The pyrogen question has a price, and it is not the price of a purity run
A compendial sterility test takes fourteen days of incubation and consumes the containers tested. That timescale is incompatible with the business model that made…
Six lines that would make an identity statement checkable
None of what a checkable identity statement requires is commercially sensitive, and all of it is known to whoever produced the document.
How a claim degrades between the bench and the listing
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.
How a single percentage came to stand for quality
This piece takes the measurement apart into the decisions it is made of, because each decision moves the answer.
Specification and result are two columns, and only one of them is a measurement
The arithmetic of significant figures, applied to a document that routinely reports four of them.
Independent analysis puts a CPC dulaglutide lot at 96.5%, against 94.8% on the certificate
The supplier has not disputed the finding. It has not explained the gap either.
Sterility is not a percentage, which is the whole difficulty
Every certificate circulating in this market answers a question about molecules. Almost none answers a question about organisms, pyrogens, or the integrity of the seal.
Why the independent testing market grew a chemistry arm and not a microbiology one
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.