Benzyl alcohol is a preservative, not a sterilising agent
We set out what is known, what is inferred and what is simply assumed about the fortnight after a vial is opened.
Reconstitution
Page 8 of 12 of this archive, newest first.
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.
The degradation product that elutes underneath the parent peak
Reversed-phase chromatography runs in an organic, acidic mobile phase that dissociates most non-covalent aggregates on the way to the detector.
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.
One vial, four weeks, and the data that does not exist
Every degradation pathway accelerates by orders of magnitude on reconstitution, because the solvent that lyophilisation removed is the reagent most of them need.
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.
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.
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.
The retest date and the expiry date are not the same document
What would make a difference is not a regulator. It is three lines on a certificate, all of which are already known to whoever wrote it.
Priming a pen is not optional
Aseptic technique here is four steps and none of them are difficult. They are, however, routinely compressed to two.
The question no chromatogram has ever answered
Purity, content, identity, sterility and endotoxin are five separate determinations. A single sheet of paper carrying one of them is not evidence about the other four.
The convention nobody explains before handing over the vial
The graduation interval differs between barrel sizes, and a 1 mL barrel is frequently marked in two-unit steps. Reading one as though it were marked in single units halves…
Units, millilitres, milligrams: three scales on one small object
The graduation interval differs between barrel sizes, and a 1 mL barrel is frequently marked in two-unit steps. Reading one as though it were marked in single units halves…
The retest date and the expiry date are not the same document
We asked twenty companies three questions about stability data and print every answer, refusal and non-response.
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…
The retest date and the expiry date are not the same document
A stability programme needs a protocol, defined conditions, a stability-indicating method and time. Time is the ingredient no commercial testing service can sell.
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.
What Sweden customs does to a parcel it has decided to examine
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.
Freezing a reconstituted vial: the ice-water interface problem
We set out what is known, what is inferred and what is simply assumed about the fortnight after a vial is opened.