Site selection when the tissue has already changed
A rotation scheme that is too complicated will not be followed. We describe the simple ones that are.
Sterility
Page 7 of 7 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.
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.
A vial can be 99.4 per cent pure and not sterile in the same afternoon
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.
A needle is a single-use instrument
For licensed products the in-use period is established by stability data. For a peptide reconstituted at home there is no such data, and the honest answer is that nobody…
Site selection when the tissue has already changed
A rotation scheme that is too complicated will not be followed. We describe the simple ones that are.
Lipohypertrophy, and the absorption it ruins
A rotation scheme that is too complicated will not be followed. We describe the simple ones that are.
Low endotoxin recovery: the interference nobody looks for
We submitted vials for endotoxin determination and report the results, the method and the laboratory, because a pyrogen figure without a method is as empty as a purity…
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.
A needle is a single-use instrument
A needle blunts on first use. Reuse is uncomfortable, and it is a documented contributor to lipohypertrophy.
What a 1 mL syringe does that a 0.3 mL syringe does not
A unit is a volume. A dose is a mass. The bridge between them is concentration, and concentration is a number somebody has to calculate.