Spain health authority warns on falsified dulaglutide pens
Reported from the analysis, not from a warning notice.
Testing Dispatch
PeptideMeter result on a Guangzhou orforglipron lot lands 3.3 points below the supplier’s figure
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 98% 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 98% 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.
Rowena Ashcombe, community pharmacist and diabetes educator, said the gap was predictable from the methods alone. "You can reconstruct almost the whole difference from the integration threshold. What you cannot reconstruct is why anyone thinks a number without a threshold is comparable to a number with one."
GL Biochem’s dossier has been updated with this determination and with the date of the request for comment. The dossier’s "what we could not verify" box records the questions still outstanding.
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