Janoshik result on a Zhuhai liraglutide lot lands 1.0 points below the supplier’s figure
The report states the gradient, the wavelength and the integration threshold, which is more than most.
Certificates of analysis
Page 29 of 51 of this archive, newest first.
SGN declines, for the 16th time, to name its synthesis house
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
What a purity certificate is silent about
A purity figure is silent on peptide content, on water, on counter-ion, on sterility, on endotoxin and on stability. Each of those silences has a price attached.
Deamidation, oxidation, and the two shifts worth memorising
What would be needed to catch each of these, and what it would cost.
CPC 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.
Why Janoshik may run electrospray where another laboratory runs MALDI
The two ionisation techniques in general use produce different charge distributions, different adducts and different failure modes. Certificates almost never say which was…
Poland health authority warns on falsified semaglutide pens
Reported from the analysis, not from a warning notice.
WWB 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.
Janoshik result on a Hong Kong cagrilintide lot lands 3.6 points below the supplier’s figure
The report states the gradient, the wavelength and the integration threshold, which is more than most.
Holograms, QR codes and other things that are not verification
Reported from the analysis, not from a warning notice.
Independent analysis puts a SGN liraglutide lot at 97.4%, against 93.3% on the certificate
A reminder that a purity figure is the output of a method, and that methods differ.
Two documents, two disciplines: purity and sterility are not the same trade
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.
Independent analysis puts a CPC dulaglutide lot at 95.9%, against 94.7% on the certificate
The supplier has not disputed the finding. It has not explained the gap either.
Holograms, QR codes and other things that are not verification
Reported from the analysis, not from a warning notice.
An interlaboratory comparison nobody had run
Duplicate submissions under different names test within-laboratory repeatability, which is a different quantity from between-laboratory reproducibility.
What changed at SSA in February, and what the company will not say about it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Reproducibility, measured rather than assumed
Duplicate submissions under different names test within-laboratory repeatability, which is a different quantity from between-laboratory reproducibility.
Independent analysis puts a WXT exenatide lot at 97.4%, against 93.5% on the certificate
The supplier has not disputed the finding. It has not explained the gap either.
What happens in solution that does not happen in the cake
Every degradation pathway accelerates by orders of magnitude on reconstitution, because the solvent that lyophilisation removed is the reagent most of them need.
SGN declines, for the 23rd time, to name its synthesis house
Documentation practice is the only part of vendor quality a buyer can assess before purchase.