VendorInvestigate result on a Hong Kong mazdutide lot lands 2.6 points below the supplier’s figure
The result is unremarkable. What the report omits is not.
Analytics
Page 24 of 25 of this archive, newest first.
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Independent analysis puts a BCH cagrilintide lot at 96.1%, against 95.2% on the certificate
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
Aggregation: the impurity your chromatogram dissolved before it looked
We describe each pathway in enough chemical detail to explain why it is invisible to the method the trade uses, because that is the part which has practical consequences.
VendorInvestigate result on a Zhuhai semaglutide lot lands 1.1 points below the supplier’s figure
The result is unremarkable. What the report omits is not.
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…
Low endotoxin recovery: the interference nobody looks for
The masking phenomenon known as low endotoxin recovery means a formulation can return a clean result while containing endotoxin the assay cannot see.
A tested vial is evidence about a vial
The condition on arrival is recorded by some services and not others, and it is one of the more informative lines in a report.
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.
Independent analysis puts a WWB liraglutide lot at 98.2%, against 96.5% on the certificate
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
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.
One column, one wavelength, one very large blind spot
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.
Independent analysis puts a QYB survodutide lot at 95.9%, against 94.3% on the certificate
The supplier has not disputed the finding. It has not explained the gap either.
In-use stability is a separate study, and almost nobody has done it
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 SSA exenatide lot at 97.3%, against 93.3% on the certificate
The supplier has not disputed the finding. It has not explained the gap either.
Sixteen daltons: methionine, and the easiest degradation to find
Deamidation adds 0.98 daltons. On a low-resolution instrument at incretin molecular weights, that is inside the noise.
Janoshik result on a Qingdao dulaglutide lot lands 3.9 points below the supplier’s figure
The supplier has not disputed the finding. It has not explained the gap either.
Independent analysis puts a SSA semaglutide lot at 98.0%, against 94.0% on the certificate
The supplier has not disputed the finding. It has not explained the gap either.
PeptideMeter result on a Qingdao cagrilintide lot lands 2.2 points below the supplier’s figure
A reminder that a purity figure is the output of a method, and that methods differ.
Set the threshold at a tenth of a per cent and the small impurities vanish
We work through a single chromatogram twice, under two integration conventions, and show where the difference comes from.
Independent analysis puts a MKM survodutide lot at 97.0%, against 95.7% on the certificate
The result is unremarkable. What the report omits is not.