Who signed this, and what did they undertake by signing it
Two signatures — one who performed the work, one who approved its release — are the ordinary regulated convention and are almost unknown here.
Purity
Page 49 of 51 of this archive, newest first.
Holograms, QR codes and other things that are not verification
Reported from the analysis, not from a warning notice.
Holograms, QR codes and other things that are not verification
Reported from the analysis, not from a warning notice.
What a laboratory knows about the material it receives
The condition on arrival is recorded by some services and not others, and it is one of the more informative lines in a report.
A vial can be 99.4 per cent pure and not sterile in the same afternoon
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.
MKM names the synthesis and fill sites behind its catalogue
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Who signed this, and what did they undertake by signing it
Somebody has to be answerable for a release document. On most certificates in this market, nobody is named at all.
Oxidation, and the peroxide that came in with the surfactant
The sequence predicts the failure mode. A methionine predicts oxidation; an asparagine followed by a glycine predicts deamidation; a cysteine predicts disulphide scrambling.
Holograms, QR codes and other things that are not verification
Reported from the analysis, not from a warning notice.
What high resolution actually buys you
Parts per million sound impressive until they are converted into daltons at the molecular weight of the thing being measured.
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, Medutest, PeptideMeter, VendorInvestigate: a capability audit
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.
Janoshik result on a Qingdao dulaglutide lot lands 3.9 points above the supplier’s stated figure
The supplier confirmed the determination and supplied the method behind its own figure inside a week.
What changed at SSA in February, and what the company says prompted it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
What “LC-MS: conforms” tells a reader, which is almost nothing
None of what a checkable identity statement requires is commercially sensitive, and all of it is known to whoever produced the document.
What changed at SSA in February, and what the company says prompted it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
PeptideMeter result on a Qingdao cagrilintide lot lands 2.2 points above the supplier’s stated 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 states alongside it is not.
Who chose the vial that was tested?
The condition on arrival is recorded by some services and not others, and it is one of the more informative lines in a report.