Janoshik result on a Shenzhen liraglutide lot lands 1.2 points above the supplier’s stated figure

Janoshik has released a batch of 6 analytical reports on research-grade liraglutide lots, including material from HJ and MKM. Reported purities range across roughly 1.2 percentage points, and the report set is unusual in stating the analytical method for every determination rather than for some of them.

Content by elemental nitrogen determination returned 97% of the labelled nominal mass, which on a 15 mg vial corresponds to roughly 8.02 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."

HJ’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.