Set the threshold at a tenth of a per cent and the small impurities vanish
We work through a single chromatogram twice, under two integration conventions, and show where the difference comes from.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
How purity, identity and content are measured, by whom, on what instrument, under what method — and what a certificate of analysis can and cannot support. Coverage of the four independent testing services: Janoshik, Medutest, PeptideMeter and VendorInvestigate.
We work through a single chromatogram twice, under two integration conventions, and show where the difference comes from.
The result is unremarkable. What the report omits is not.
A reminder that a purity figure is the output of a method, and that methods differ.
Nothing on this page is difficult. It is simply unfamiliar, and unfamiliarity is what makes a weak certificate look like a strong one.
The report states the gradient, the wavelength and the integration threshold, which is more than most.
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.
The Journal does not treat a badge as evidence and states so wherever it reports one.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
Calibration drift is real, unremarkable, and the reason serious laboratories run internal standards.
Deamidation adds 0.98 daltons. On a low-resolution instrument at incretin molecular weights, that is inside the noise.
A reminder that a purity figure is the output of a method, and that methods differ.
The report states the gradient, the wavelength and the integration threshold, which is more than most.
The supplier has not disputed the finding. It has not explained the gap either.
The result is unremarkable. What the report omits is not.
Regulated pharmaceutical practice has explicit reporting, identification and qualification thresholds. This trade has none, which is why a purity figure carries no…
We asked twenty companies three questions about stability data and print every answer, refusal and non-response.
The masking phenomenon known as low endotoxin recovery means a formulation can return a clean result while containing endotoxin the assay cannot see.
The result is unremarkable. What the report omits is not.
The result is unremarkable. What the report omits is not.
The report states the gradient, the wavelength and the integration threshold, which is more than most.