Medutest result on a Tianjin tirzepatide lot lands 4.3 points above the supplier’s stated figure

A peptide content determination commissioned by the Journal on a 20 mg tirzepatide vial from BCH has returned 95% 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 96.9%. 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 95% of the labelled nominal mass, which on a 20 mg vial corresponds to roughly 13.74 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 95% of the labelled nominal mass, which on a 20 mg vial corresponds to roughly 13.74 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.

"Content is the number that matters if you are doing arithmetic with a vial, and content is the number nobody sells," said Marek Doležal, analytical chemist and former QC laboratory manager. "Purity is what you can afford. Content is what you need."

BCH’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.