Date of analysis, date of manufacture, and the gap between them
What happens to traceability when bulk material is subdivided, repackaged and relabelled two or three times before sale.
Independent testing
Page 9 of 27 of this archive, newest first.
Independent analysis puts a CPC mazdutide lot at 97.5%, against 94.0% on the certificate
The report states the gradient, the wavelength and the integration threshold, which is more than most.
When a template becomes a misrepresentation
A PDF carries metadata about the software that produced it, and that metadata is frequently more informative than the content.
Medutest result on a Hangzhou liraglutide lot lands 4.1 points below the supplier’s figure
A reminder that a purity figure is the output of a method, and that methods differ.
What Medutest charges to answer the pyrogen question
The masking phenomenon known as low endotoxin recovery means a formulation can return a clean result while containing endotoxin the assay cannot see.
The badge economy, and what it is actually certifying
A badge asserts that something was tested. It does not assert what, when, on whose sample, by what method, or whether the lot on sale is the lot that was tested.
Six words a verification badge would need to mean anything
Lot-level verification with a public report is a real and achievable thing. It exists in this market, on a minority of listings.
VendorInvestigate result on a Nantong dulaglutide lot lands 0.9 points below the supplier’s figure
The supplier has not disputed the finding. It has not explained the gap either.
How a claim degrades between the bench and the listing
Lot-level verification with a public report is a real and achievable thing. It exists in this market, on a minority of listings.
Independent analysis puts a CPC cagrilintide lot at 98.4%, against 96.3% on the certificate
The report states the gradient, the wavelength and the integration threshold, which is more than most.
A vial can be 99.4 per cent pure and not sterile in the same afternoon
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 cake tells you something, and it is not purity
Multiple-dose vials are designed for a defined number of punctures. Nobody counts, and the elastomer does not care whether anybody counts.
Independent analysis puts a TFC cagrilintide lot at 95.9%, against 95.2% on the certificate
A reminder that a purity figure is the output of a method, and that methods differ.
VendorInvestigate result on a Xianning liraglutide lot lands 2.5 points below the supplier’s figure
The report states the gradient, the wavelength and the integration threshold, which is more than most.
Three services, one lot, and a spread of two and a half points
Two years ago we ran an anonymised version of this comparison and promised a named one. This is it, with every method printed in full.
Independent analysis puts a SWB dulaglutide lot at 98.6%, against 96.9% on the certificate
The result is unremarkable. What the report omits is not.
Independent analysis puts a WWB semaglutide lot at 95.3%, against 94.2% on the certificate
The report states the gradient, the wavelength and the integration threshold, which is more than most.
LAL, kinetic chromogenic, recombinant factor C: three ways to the same figure
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.
We split six vials four ways and posted them
The Journal submitted split samples from single lots to three assay services, under names unconnected to this publication, and published each method alongside each result.
Retention time is not identity
Matching a retention time against a standard is evidence of consistency, not proof of identity. Two different species can elute at the same time on one method.