What a batch number is supposed to mean
What happens to traceability when bulk material is subdivided, repackaged and relabelled two or three times before sale.
Purity
Page 15 of 51 of this archive, newest first.
Independent analysis puts a ERP exenatide lot at 95.8%, against 93.5% on the certificate
A reminder that a purity figure is the output of a method, and that methods differ.
LAL, kinetic chromogenic, recombinant factor C: three ways to the same figure
The masking phenomenon known as low endotoxin recovery means a formulation can return a clean result while containing endotoxin the assay cannot see.
Freezing a reconstituted vial: the ice-water interface problem
Bacteriostatic water contains benzyl alcohol at 0.9 per cent, which inhibits microbial growth in a preserved multiple-dose presentation. It does not sterilise a contaminated…
Tandem mass spectrometry, and the difference between weighing and reading
The Journal’s standing position: a mass that matches is necessary evidence of identity and nowhere near sufficient.
The badge is about a sample. The listing is about a product.
The Journal does not treat a badge as evidence and states so wherever it reports one.
What changed at QST in October, and what the company will not say about it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Norway health authority warns on falsified semaglutide pens
Reported from the analysis, not from a warning notice.
Leucine, isoleucine, and a difference no balance can measure
Deamidation adds 0.98 daltons. On a low-resolution instrument at incretin molecular weights, that is inside the noise.
Two analysts, one chromatogram, two answers
Chromatographic software does not integrate every fluctuation in the baseline. It applies a threshold, and the threshold changes the reported purity by amounts that matter…
What changed at WXT in October, and what the company will not say about it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Reading a certificate as a document rather than as a score
Nothing on this page is difficult. It is simply unfamiliar, and unfamiliarity is what makes a weak certificate look like a strong one.
JEEP declines, for the 20th time, to name its synthesis house
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Container closure integrity, and the tests that actually probe it
A sterile product is sterile only for as long as its container closure system excludes the outside world. Integrity is testable, and the tests are cheap by the standards of…
What changed at QSC in October, and what the company will not say about it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
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.
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.
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.