What changed at SGN in April, and what the company will not say about it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Purity
Page 5 of 51 of this archive, newest first.
Deamidation is the commonest degradation route and the hardest to see
An isoaspartate rearrangement changes the molecule and not the mass. A method that confirms identity by molecular weight alone will report it as the parent compound.
Same material, different gradients, different answers
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 MKM survodutide lot at 96.5%, against 95.5% on the certificate
The report states the gradient, the wavelength and the integration threshold, which is more than most.
ERP declines, for the 14th time, to name its synthesis house
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Benzyl alcohol is a preservative, not a sterilising agent
Bacteriostatic water contains benzyl alcohol at 0.9 per cent, which inhibits microbial growth in a preserved multiple-dose presentation. It does not sterilise a contaminated…
Independent analysis puts a QST orforglipron lot at 96.6%, against 94.6% on the certificate
A reminder that a purity figure is the output of a method, and that methods differ.
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.
The certificate says 2026. The vial in your hand does not say anything.
What happens to traceability when bulk material is subdivided, repackaged and relabelled two or three times before sale.
GL Biochem declines, for the 8th time, to name its synthesis house
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Sweden health authority warns on falsified exenatide pens
Reported from the analysis, not from a warning notice.
PeptideMeter result on a Suzhou liraglutide lot lands 4.0 points below the supplier’s figure
The result is unremarkable. What the report omits is not.
Janoshik result on a Zhuhai tirzepatide lot lands 2.5 points below the supplier’s figure
A reminder that a purity figure is the output of a method, and that methods differ.
Low endotoxin recovery: the interference nobody looks for
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 FGP exenatide lot at 95.8%, against 93.2% on the certificate
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
What changed at TFC in April, and what the company will not say about it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Japan health authority warns on falsified liraglutide pens
Reported from the analysis, not from a warning notice.
Two ways to lift a peptide into a vacuum, and why the answer differs
The ionisation method determines the charge states you see, the adducts you must account for, and the modifications you might destroy in the process.
Why VendorInvestigate can tell you the mass is right and not that the sequence is
The Journal’s standing position: a mass that matches is necessary evidence of identity and nowhere near sufficient.