The pyrogen question has a price, and it is not the price of a purity run
A compendial sterility test takes fourteen days of incubation and consumes the containers tested. That timescale is incompatible with the business model that made…
Purity
Page 13 of 51 of this archive, newest first.
The United Kingdom health authority warns on falsified semaglutide pens
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 changed at ERP in December, and what the company will not say about it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
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.
What changed at FGP in November, and what the company will not say about it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
The United Arab Emirates health authority warns on falsified exenatide pens
Reported from the analysis, not from a warning notice.
What the four services actually offer, test by test
Endotoxin is the more tractable of the two questions, and a kinetic chromogenic determination is neither slow nor exotic. It is simply not on the menu.
The wavelength decides which impurities exist
Peptide bonds absorb strongly near 214 nm; aromatic side chains absorb near 280 nm. A method reading at 280 is blind to any fragment lacking an aromatic residue.
The cleanroom grade nobody names on the paperwork
The compendial sterility test cannot demonstrate that a batch is sterile. It can only fail a batch that is grossly contaminated. Everything else is process validation.
Medutest result on a Chengdu cagrilintide lot lands 4.4 points below the supplier’s figure
A reminder that a purity figure is the output of a method, and that methods differ.
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…
What changed at GL Biochem in November, and what the company will not say about it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
TFC declines, for the 18th time, to name its synthesis house
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Six lines that would make an identity statement checkable
None of what a checkable identity statement requires is commercially sensitive, and all of it is known to whoever produced the document.
JEEP declines, for the 21st time, to name its synthesis house
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Italy health authority warns on falsified dulaglutide pens
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.
Reproducibility, measured rather than assumed
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.
What changed at WXT in November, and what the company will not say about it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.