Independent analysis puts a JEEP tirzepatide lot at 96.0%, against 92.6% on the certificate

Janoshik has released a batch of 13 analytical reports on research-grade tirzepatide lots, including material from JEEP and SGN. Reported purities range across roughly 0.9 percentage points, and the report set is unusual in stating the analytical method for every determination rather than for some of them.

The Journal purchased 18 vials from the same lot at retail and had four of them analysed separately, in order to distinguish vial-to-vial variation from method variation. Vial-to-vial agreement was within 0.4 percentage points. Method-to-method disagreement was an order of magnitude larger.

Content by elemental nitrogen determination returned 97% of the labelled nominal mass, which on a 15 mg vial corresponds to roughly 5.15 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.

"Ask for the suitability summary before you argue about the percentage," said Dr Emiko Tanabe, mass spectrometrist. "If the tailing factor and the replicate precision are outside limits, you are arguing about arithmetic performed on an unfit separation."

JEEP’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.