Janoshik result on a Nantong exenatide lot lands 3.1 points below the supplier’s figure
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
Independent testing
Page 23 of 27 of this archive, newest first.
What VendorInvestigate charges to answer the pyrogen question
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 SGN liraglutide lot at 95.7%, against 93.4% on the certificate
The supplier has not disputed the finding. It has not explained the gap either.
What “LC-MS: conforms” tells a reader, which is almost nothing
What the Journal asks for when it writes to a supplier about an identity claim, and how often it gets it.
The qualification chain nobody in this trade can show you
Accreditation to the international competence standard covers the scope a laboratory has been assessed for, which is not necessarily the test you commissioned.
How a release document is put together in a regulated plant
The purity figure is the least informative line on a well-constructed certificate and the only line most buyers read.
PeptideMeter result on a Tianjin mazdutide lot lands 4.3 points below the supplier’s figure
The supplier has not disputed the finding. It has not explained the gap either.
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.
Who signed this, and what did they undertake by signing it
What the Journal asks when a document arrives unsigned, and what the answers have been.
The anatomy of the most reproduced page in this trade
The purity figure is the least informative line on a well-constructed certificate and the only line most buyers read.
Independent analysis puts a WWB survodutide lot at 99.2%, against 95.5% on the certificate
The supplier has not disputed the finding. It has not explained the gap either.
Endotoxin is not a microorganism, and killing the bacteria does not remove it
Three compendial method families are in routine use and a fourth, based on a recombinant enzyme rather than crab lysate, is now compendial in its own right.
Independent analysis puts a WXT semaglutide lot at 98.8%, against 95.3% on the certificate
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
VendorInvestigate result on a Zhuhai dulaglutide lot lands 2.6 points below the supplier’s figure
A reminder that a purity figure is the output of a method, and that methods differ.
What we are not saying about anybody in this trade
None of what this piece asks for is commercially sensitive, and all of it is already known to whoever released the batch.
Quadrupole, time-of-flight, orbital trap: what each class can and cannot see
Parts per million sound impressive until they are converted into daltons at the molecular weight of the thing being measured.
What the paperwork is for, and who it was designed to protect
The header identifies the batch, the table records the tests, and the footer says who is answerable. Two of the three are usually incomplete.
Why a dead-clean sterile filter can pass pyrogen straight through
The masking phenomenon known as low endotoxin recovery means a formulation can return a clean result while containing endotoxin the assay cannot see.
PeptideMeter result on a Guangzhou orforglipron lot lands 3.3 points below the supplier’s figure
A reminder that a purity figure is the output of a method, and that methods differ.
How to audit an identity claim in five minutes
The regulated world states the method, the instrument, the convention and the tolerance. This market states a verdict.