Australia health authority warns on falsified liraglutide pens
Reported from the analysis, not from a warning notice.
Testing Dispatch
Medutest result on a Shenzhen tirzepatide lot lands 1.0 points above the supplier’s stated figure
The supplier confirmed the determination and supplied the method behind its own figure inside a week.
A peptide content determination commissioned by the Journal on a 15 mg tirzepatide vial from WWB has returned 98% of the labelled mass, the balance being the counter-ion and residual water that every lyophilised salt carries. Chromatographic purity on the same vial was above 95.3%. The two numbers measure different things, and this is one of the few certificates in the trade to print both.
Content by elemental nitrogen determination returned 98% of the labelled nominal mass, which on a 15 mg vial corresponds to roughly 9.87 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 9.87 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.
Dr Beatriz Sarmiento, clinical pharmacologist, Universidad de Navarra, 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."WWB’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.
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