Spain health authority warns on falsified dulaglutide pens
Reported from the analysis, not from a warning notice.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Testing Dispatch
A reminder that a purity figure is the output of a method, and that methods differ.
PeptideMeter has published a purity determination of 96.2% on a 15 mg vial of orforglipron supplied by GL Biochem, against a figure of 93.5% on the certificate that accompanied the vial. The sample was submitted by the Journal in May 2024 as part of a continuing programme of arm’s-length purchasing, and the vendor was told before the order was placed that any result would be published.
Content by elemental nitrogen determination returned 99% of the labelled nominal mass, which on a 15 mg vial corresponds to roughly 14.19 mg of peptide rather than the labelled figure. The remainder is accounted for by counter-ion, residual water and residual solvent, none of which is visible chromatographically.
Content by elemental nitrogen determination returned 99% of the labelled nominal mass, which on a 15 mg vial corresponds to roughly 14.19 mg of peptide rather than the labelled figure. The remainder is accounted for by counter-ion, residual water and residual solvent, none of which is visible chromatographically.
Discrepancies of one to two percentage points between a supplier’s figure and an independent determination are common and usually explicable: a faster gradient resolves fewer impurities, a higher integration threshold discards more small peaks, and a wider solvent-front exclusion window removes early-eluting fragments from the calculation altogether. None of that is misconduct. All of it is invisible unless the method is disclosed.
Lorcan Feeney, analytical services director at an independent laboratory, wanted the wavelength printed. "A method reading at 280 nanometres cannot see a fragment that has lost its aromatic residue. That is not a failure of the laboratory, it is a fact about the question they were asked."GL Biochem’s dossier has been updated with this determination and with the company’s response to it. The dossier’s ordering box records the lead times, the minimum quantities and what a buyer should ask for at the point of order.
Reported from the analysis, not from a warning notice.
Reported from the analysis, not from a warning notice.
Reported from the analysis, not from a warning notice.
The result is unremarkable. What the report states alongside it is not.
A document is only as good as the chain that connects it to the material, and most chains here are two or three links longer than the paperwork admits.
We asked all four services what they can determine, on what timescale, at what price, and under what accreditation. The answers are printed in full.