Gauge, pain and flow rate
The insulin injection-technique literature is large, well conducted and directly transferable on questions of depth and tissue. We say where it stops transferring.
Reconstitution
Page 7 of 12 of this archive, newest first.
The 0.22 micron filter does the work, and it is the last line
Bioburden entering the filter, filter integrity, environmental monitoring and aseptic process simulation are the four pillars. The trade documents none of them.
Why a dead-clean sterile filter can pass pyrogen straight through
Three compendial method families are in routine use and a fourth, based on a recombinant enzyme rather than crab lysate, is now compendial in its own right.
What PeptideMeter charges to answer the pyrogen question
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…
Why a dead-clean sterile filter can pass pyrogen straight through
The limit for a parenteral product is calculable from the dose and the body weight in two lines. Almost nobody in this trade performs the calculation.
Why a dead-clean sterile filter can pass pyrogen straight through
The limit for a parenteral product is calculable from the dose and the body weight in two lines. Almost nobody in this trade performs the calculation.
Bacteriostatic water, sterile water, and the 0.9 per cent that makes the difference
Every degradation pathway accelerates by orders of magnitude on reconstitution, because the solvent that lyophilisation removed is the reagent most of them need.
The intramuscular injection nobody intended
Skin thickness at the standard injection sites is approximately two millimetres in adults and varies remarkably little with body mass. That single finding is why short…
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 twenty companies say about storage, and what they have measured
Storage instructions in this market are close to uniform and almost never accompanied by the study that would justify them. Uniformity is a sign of convention, not of…
The site you keep using is the site that stops working
Lipohypertrophic tissue is less painful to inject into, which is precisely why people keep injecting into it.
Oxidation, and the peroxide that came in with the surfactant
We describe each pathway in enough chemical detail to explain why it is invisible to the method the trade uses, because that is the part which has practical consequences.
The question no chromatogram has ever answered
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.
The empty half of every certificate of analysis
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.
Priming a pen is not optional
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…
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.
Why a dead-clean sterile filter can pass pyrogen straight through
The limit for a parenteral product is calculable from the dose and the body weight in two lines. Almost nobody in this trade performs the calculation.
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.
Freezing a reconstituted vial: the ice-water interface problem
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…
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.