LAL, kinetic chromogenic, recombinant factor C: three ways to the same figure
Bacterial endotoxin is a heat-stable lipopolysaccharide from the outer membrane of Gram-negative organisms. It survives sterilisation, passes a sterilising filter, and is…
Fill & finish
Page 11 of 11 of this archive, newest first.
Low endotoxin recovery: the interference nobody looks for
The masking phenomenon known as low endotoxin recovery means a formulation can return a clean result while containing endotoxin the assay cannot see.
Why FGP can be entirely straightforward and still tell you nothing about bioburden
The Journal has read several hundred certificates from twenty companies. We set out what the documents actually cover, and what a reader is filling in from imagination.
Collapse temperature, and the hour of the cycle where shelf life is lost
The physics of the drying cycle explains why some cakes are matte and full-volume and others are glassy discs, and why the difference is not cosmetic.
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.
One column, one wavelength, one very large blind spot
The Journal has read several hundred certificates from twenty companies. We set out what the documents actually cover, and what a reader is filling in from imagination.
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.
In-use stability is a separate study, and almost nobody has done it
An in-use period is established by a dedicated study on a specific formulation in a specific container at a specific concentration. Borrowing one from a marketed product is…
Specification and result are two columns, and only one of them is a measurement
Statements of conformity are supposed to rest on a stated decision rule. Almost nothing in this trade states one.
Adsorption, and the dose that stayed on the glass
Every degradation pathway accelerates by orders of magnitude on reconstitution, because the solvent that lyophilisation removed is the reagent most of them need.
The cold chain in this trade is a gel pack and an optimistic estimate
A gel pack has a finite thermal budget, and once it is spent the payload equilibrates with whatever is outside the box. The only question is how long that takes.
The retest date and the expiry date are not the same document
A retest date says that material should be re-examined before use. An expiry date says it should not be used. The trade uses the second word for the first concept.
A named analyst is the cheapest quality signal in this trade
What the Journal asks when a document arrives unsigned, and what the answers have been.
What twenty companies say about storage, and what they have measured
A retest date says that material should be re-examined before use. An expiry date says it should not be used. The trade uses the second word for the first concept.
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.
How to read the silence on a certificate you already hold
Our position is about documentation practice. It is not an allegation about anybody’s honesty, and we are explicit about the difference.