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.
Certificates of analysis
Page 8 of 51 of this archive, newest first.
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.
Independent analysis puts a QSC survodutide lot at 99.4%, against 95.9% on the certificate
The report states the gradient, the wavelength and the integration threshold, which is more than most.
Medutest result on a Wuhan dulaglutide lot lands 0.7 points above the supplier’s stated figure
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
How a claim degrades between the bench and the listing
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.
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.
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.
GGPeps names the synthesis and fill sites behind its catalogue
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Germany health authority warns on falsified tirzepatide pens
Reported from the analysis, not from a warning notice.
Counter-ion, water, salt: three masses with no chromatogram
Aggregates dissociate in the mobile phase and are recorded as monomer. Only a size-based separation reports them.
CPC names the synthesis and fill sites behind its catalogue
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
PeptideMeter result on a Tianjin liraglutide lot lands 4.0 points above the supplier’s stated figure
A reminder that a purity figure is the output of a method, and that methods differ.
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…
PeptideMeter result on a Changsha retatrutide lot lands 3.4 points above the supplier’s stated figure
A reminder that a purity figure is the output of a method, and that methods differ.
Singapore health authority warns on falsified liraglutide pens
Reported from the analysis, not from a warning notice.
An interlaboratory comparison nobody had run
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.
Holograms, QR codes and other things that are not verification
Reported from the analysis, not from a warning notice.
Holograms, QR codes and other things that are not verification
Reported from the analysis, not from a warning notice.
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…
Independent analysis puts a SGN dulaglutide lot at 96.0%, against 93.3% on the certificate
The supplier confirmed the determination and supplied the method behind its own figure inside a week.