The degradation product that elutes underneath the parent peak
Deamidation, oxidation, aggregation and hydrolysis account for nearly all of what happens to a peptide over time. Each has a characteristic residue, a characteristic…
Fill & finish
Page 2 of 11 of this archive, newest first.
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.
The same signature, the same peak, three different batches
A blank certificate with the numbers left editable is an ordinary internal document. Its circulation as a finished record is the problem.
The chromatogram that appears on four documents
A PDF carries metadata about the software that produced it, and that metadata is frequently more informative than the content.
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.
Why SSA 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.
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.
Accreditation, scope, and the question nobody asks VendorInvestigate
Two signatures — one who performed the work, one who approved its release — are the ordinary regulated convention and are almost unknown here.
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…
Who signed this, and what did they undertake by signing it
A manufacturer’s certificate is a self-declaration. An accredited laboratory’s report is a third-party measurement. The trade prints both under one heading.
What Medutest 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…
Same mass, different molecule: why identity by mass is not identity
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.
Turnaround, cost and accreditation across the services this trade relies on
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
Four independent services underpin confidence in this market. All four are competent at chemistry. Microbiology is a different accreditation, a different facility and a…
The certificate says 2026. The vial in your hand does not say anything.
What happens to traceability when bulk material is subdivided, repackaged and relabelled two or three times before sale.
Repackaging, subdivision, and the batch number that changed hands
A document is only as good as the chain that connects it to the material, and most chains here are two or three links longer than the paperwork admits.
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…
What we asked twenty suppliers about stability data
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.