What twenty companies say about storage, and what they have measured
Storage instructions in this market are close to uniform and almost never accompanied by the study that would justify them. Uniformity is a sign of convention, not of…
Analytics
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Medutest result on a Wuxi dulaglutide lot lands 2.0 points below the supplier’s figure
The supplier has not disputed the finding. It has not explained the gap either.
Everything on the page, in the order a chemist would read it
The purity figure is the least informative line on a well-constructed certificate and the only line most buyers read.
Independent analysis puts a SSA survodutide lot at 97.1%, against 96.4% on the certificate
The result is unremarkable. What the report omits is not.
Medutest result on a Nantong semaglutide lot lands 3.0 points below the supplier’s figure
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
Independent analysis puts a QSC exenatide lot at 97.5%, against 96.7% on the certificate
The supplier has not disputed the finding. It has not explained the gap either.
The retest date and the expiry date are not the same document
We asked twenty companies three questions about stability data and print every answer, refusal and non-response.
The question no chromatogram has ever answered
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.
Medutest result on a Hangzhou dulaglutide lot lands 3.0 points below the supplier’s figure
The result is unremarkable. What the report omits is not.
Why FGP can be entirely straightforward and still tell you nothing about bioburden
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.
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.
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.
Freezing a reconstituted vial: the ice-water interface problem
An in-use period is established by a dedicated study on a specific formulation in a specific container at a specific concentration. Borrowing one from a marketed product is…
Independent analysis puts a ERP liraglutide lot at 99.4%, against 98.3% on the certificate
The result is unremarkable. What the report omits is not.
Electrospray, MALDI, and the choice that shapes every spectrum after it
The two ionisation techniques in general use produce different charge distributions, different adducts and different failure modes. Certificates almost never say which was…
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.
The degradation product that elutes underneath the parent peak
Reversed-phase chromatography runs in an organic, acidic mobile phase that dissociates most non-covalent aggregates on the way to the detector.
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.
The badge is about a sample. The listing is about a product.
Lot-level verification with a public report is a real and achievable thing. It exists in this market, on a minority of listings.