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.
Endotoxin
Page 4 of 5 of this archive, newest first.
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 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 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 the four services actually offer, test by test
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.
The fourteen-day problem, and what it does to a commercial testing model
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.
What the four services actually offer, test by test
We asked all four services what they can determine, on what timescale, at what price, and under what accreditation. The answers are printed in full.
The empty half of every certificate of analysis
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 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.
The fourteen-day problem, and what it does to a commercial testing model
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.
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.
Glass, elastomer, aluminium: a three-material argument about one closure
Particulate matter is the oldest quality attribute in injectable manufacture and the one a private buyer is best placed to assess without instrumentation.
What VendorInvestigate charges to answer the pyrogen question
Bacterial endotoxin is a heat-stable lipopolysaccharide from the outer membrane of Gram-negative organisms. It survives sterilisation, passes a sterilising filter, and is…
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.
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.
What VendorInvestigate is able to certify about a sealed vial, and what it is not
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.
Endotoxin is not a microorganism, and killing the bacteria does not remove it
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.
Endotoxin is not a microorganism, and killing the bacteria does not remove it
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 fourteen-day problem, and what it does to a commercial testing model
We asked all four services what they can determine, on what timescale, at what price, and under what accreditation. The answers are printed in full.
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…