What changed at JEEP in February, and what the company will not say about it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Testing Dispatch
Independent analysis puts a CPC cagrilintide lot at 98.4%, against 96.3% on the certificate
The report states the gradient, the wavelength and the integration threshold, which is more than most.
VendorInvestigate has released a batch of 6 analytical reports on research-grade cagrilintide lots, including material from CPC and MKM. Reported purities range across roughly 3.7 percentage points, and the report set is unusual in stating the analytical method for every determination rather than for some of them.
The Journal purchased 300 vials from the same lot and had 6 of them analysed separately, in order to distinguish vial-to-vial variation from method variation. Vial-to-vial agreement was within 0.4 percentage points. Method-to-method disagreement was an order of magnitude larger.
Four independent services — VendorInvestigate, Medutest, and the two others operating in this market — carry the analytical burden for a trade that has no release-testing obligation of its own. Each is paid by whoever submits the sample, which is usually the vendor. The Journal’s position is that a submitter-pays model is workable but that its incentive structure has to be stated whenever a result is quoted as verification.
"Content is the number that matters if you are doing arithmetic with a vial, and content is the number nobody sells," said Yusuf Kandemir, freight and customs broker, Istanbul. "Purity is what you can afford. Content is what you need."
CPC’s dossier has been updated with this determination and with the date of the request for comment. The dossier’s "what we could not verify" box records the questions still outstanding.
Related coverage
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.
Holograms, QR codes and other things that are not verification
Reported from the analysis, not from a warning notice.
Independent analysis puts a KP liraglutide lot at 97.9%, against 97.0% on the certificate
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
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 GGPeps tirzepatide lot at 95.4%, against 92.1% on the certificate
A reminder that a purity figure is the output of a method, and that methods differ.