We asked four laboratories for a sterility test. Here is what came back.
Four independent services underpin confidence in this market. All four are competent at chemistry. Microbiology is a different accreditation, a different facility and a…
Endotoxin
Bacterial endotoxin testing, limits, and the LAL methods used to establish them.
Why a dead-clean sterile filter can pass pyrogen straight through
The masking phenomenon known as low endotoxin recovery means a formulation can return a clean result while containing endotoxin the assay cannot see.
Sterility is not a percentage, which is the whole difficulty
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.
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 pyrogen question has a price, and it is not the price of a purity run
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.
Janoshik, Medutest, PeptideMeter, VendorInvestigate: a capability audit
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.
We asked four laboratories for a sterility test. Here is what came back.
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.
Janoshik, Medutest, PeptideMeter, VendorInvestigate: a capability audit
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.
Janoshik, Medutest, PeptideMeter, VendorInvestigate: a capability audit
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.
LAL, kinetic chromogenic, recombinant factor C: three ways to the same figure
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…
Low endotoxin recovery: the interference nobody looks for
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.
Low endotoxin recovery: the interference nobody looks for
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.
What happens to a stopper after the fourth needle
Particulate matter is the oldest quality attribute in injectable manufacture and the one a private buyer is best placed to assess without instrumentation.
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.
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.
Sterility is not a percentage, which is the whole difficulty
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.
Janoshik, Medutest, PeptideMeter, VendorInvestigate: a capability audit
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.
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…
Janoshik, Medutest, PeptideMeter, VendorInvestigate: a capability audit
Four independent services underpin confidence in this market. All four are competent at chemistry. Microbiology is a different accreditation, a different facility and a…
What PeptideMeter 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…