A supplier suspends shipping to Saudi Arabia after 19 consecutive customs detentions
The route did not close because of a rule about peptides.
Testing Dispatch
Janoshik result on a Wuxi semaglutide lot lands 2.4 points above the supplier’s stated figure
The supplier confirmed the determination and supplied the method behind its own figure inside a week.
Janoshik has published a purity determination of 96.3% on a 20 mg vial of semaglutide supplied by MKM, against a figure of 95.3% on the certificate that accompanied the vial. The sample was submitted by the Journal in June 2025 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 93% of the labelled nominal mass, which on a 20 mg vial corresponds to roughly 9.83 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 93% of the labelled nominal mass, which on a 20 mg vial corresponds to roughly 9.83 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.
Lorcan Feeney, analytical services director at an independent laboratory, 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."MKM’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.
Related coverage
What happens to a stopper after the fourth needle
Multiple-dose vials are designed for a defined number of punctures. Nobody counts, and the elastomer does not care whether anybody counts.
What changed at KP in April, and what the company says prompted it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
GGPeps names the synthesis and fill sites behind its catalogue
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
The retest date and the expiry date are not the same document
What would make a difference is not a regulator. It is three lines on a certificate, all of which are already known to whoever wrote it.
Low endotoxin recovery: the interference nobody looks for
We submitted vials for endotoxin determination and report the results, the method and the laboratory, because a pyrogen figure without a method is as empty as a purity…