Brazil health authority warns on falsified exenatide pens
Reported from the analysis, not from a warning notice.
Certificates of analysis
Page 20 of 51 of this archive, newest first.
A named analyst is the cheapest quality signal in this trade
Two signatures — one who performed the work, one who approved its release — are the ordinary regulated convention and are almost unknown here.
VendorInvestigate result on a Wuhan mazdutide lot lands 3.4 points above the supplier’s stated figure
The report states the gradient, the wavelength and the integration threshold, which is more than most.
We asked four laboratories for a sterility test. Here is what came back.
A compendial sterility test takes fourteen days of incubation and consumes the containers tested. That timescale is incompatible with the business model that made…
Independent analysis puts a QSC liraglutide lot at 99.2%, against 97.6% on the certificate
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
The certificate says 2025. The vial in your hand does not say anything.
The interval between manufacture and analysis is the most under-read figure on the page, and the one most likely to matter by the time a vial is opened.
What happens to a stopper after the fourth needle
Multiple-dose vials are designed for a defined number of punctures. Nobody counts, and the elastomer does not care whether anybody counts.
ERP names the synthesis and fill sites behind its catalogue
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Independent analysis puts a GL Biochem liraglutide lot at 96.0%, against 93.9% on the certificate
A reminder that a purity figure is the output of a method, and that methods differ.
Sterility is not a percentage, which is the whole difficulty
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.
The named comparison we promised two years ago
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.
What changed at GL Biochem in July, and what the company says prompted it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
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.
Holograms, QR codes and other things that are not verification
Reported from the analysis, not from a warning notice.
WWB names the synthesis and fill sites behind its catalogue
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
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…
Holograms, QR codes and other things that are not verification
Reported from the analysis, not from a warning notice.
Who signed this, and what did they undertake by signing it
Two signatures — one who performed the work, one who approved its release — are the ordinary regulated convention and are almost unknown here.
What changed at SSA in July, and what the company says prompted it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
What twenty companies say about storage, and what they have measured
A stability programme needs a protocol, defined conditions, a stability-indicating method and time. Time is the ingredient no commercial testing service can sell.