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.
Sterility
Page 5 of 7 of this archive, newest first.
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.
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…
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.
Errors ranked by how much dose they move
A pharmacist catches most of these in licensed practice. In this market there is no pharmacist, so the checks have to be structural.
In-use periods, and the ones nobody can give you
Sharps disposal is a legal obligation in most jurisdictions and a safety obligation everywhere. Household waste is not a route.
We asked four laboratories for a sterility test. Here is what came back.
The absence of microbiological capability in this market is a commercial fact with a straightforward explanation, and it is worth understanding before blaming anybody for it.
Choosing a needle for a subcutaneous peptide
Gauge affects pain and flow rate rather than depth. A finer needle is more comfortable and slower, and with a viscous solution the difference is noticeable.
Why TFC 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.
LAL, kinetic chromogenic, recombinant factor C: three ways to the same figure
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.
Two documents, two disciplines: purity and sterility are not the same trade
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 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…
Reading a barrel in the wrong increments
Almost every case involves a change — a new vial, a new syringe size, a new supplier — carried forward with an old number.
The certificate is silent on contamination, and it never claimed otherwise
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 much water: the question with no single right answer
A more concentrated reconstitution means smaller injection volumes, which means larger proportional errors from graduation, dead space and technique.
Four millimetres is enough, and the data says so
A 4 mm needle at ninety degrees without a skin pinch is adequate for essentially all adults. The persistence of 12.7 mm needles in this market is habit, not reasoning.
Longer is not safer
The insulin injection-technique literature is large, well conducted and directly transferable on questions of depth and tissue. We say where it stops transferring.
Errors ranked by how much dose they move
The most dangerous errors are the ones that leave no trace: nothing looks wrong, the mark is in the same place, and the dose is wrong by an order of magnitude.
LAL, kinetic chromogenic, recombinant factor C: three ways to the same figure
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 question no chromatogram has ever answered
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.