The pyrogen question has a price, and it is not the price of a purity run
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.
Purity
Page 32 of 51 of this archive, newest first.
What changed at QSC in December, and what the company says prompted it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
KP names the synthesis and fill sites behind its catalogue
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
The badge economy, and what it is actually certifying
What a verification mark would have to carry to be checkable: a date, a lot, a method, a submitter and a link to the report.
Oxidation, and the peroxide that came in with the surfactant
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.
Independent analysis puts a ERP liraglutide lot at 99.4%, against 98.3% on the certificate
The result is unremarkable. What the report states alongside it is not.
CPC names the synthesis and fill sites behind its catalogue
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Holograms, QR codes and other things that are not verification
Reported from the analysis, not from a warning notice.
Electrospray, MALDI, and the choice that shapes every spectrum after it
The two ionisation techniques in general use produce different charge distributions, different adducts and different failure modes. Certificates almost never say which was…
France health authority warns on falsified tirzepatide pens
Reported from the analysis, not from a warning notice.
Sweden health authority warns on falsified exenatide pens
Reported from the analysis, not from a warning notice.
Reading a certificate as a document rather than as a score
The header identifies the batch, the table records the tests, and the footer says who is answerable. Two of the three are usually incomplete.
Independent analysis puts a QST exenatide lot at 98.4%, against 95.6% on the certificate
A reminder that a purity figure is the output of a method, and that methods differ.
What changed at QYB in December, and what the company says prompted it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
The badge is about a sample. The listing is about a product.
Lot-level verification with a public report is a real and achievable thing. It exists in this market, on a minority of listings.
The United Arab Emirates health authority warns on falsified liraglutide pens
Reported from the analysis, not from a warning notice.
CPC names the synthesis and fill sites behind its catalogue
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Holograms, QR codes and other things that are not verification
Reported from the analysis, not from a warning notice.
Spain health authority warns on falsified liraglutide pens
Reported from the analysis, not from a warning notice.
What changed after we published the first version of this
A reader holding a certificate can work out what it does not cover in about ninety seconds, and that is a useful ninety seconds.