Janoshik result on a Zhuhai liraglutide lot lands 1.0 points above the supplier’s stated figure

Janoshik has released a batch of 4 analytical reports on research-grade liraglutide lots, including material from WXT and FGP. Reported purities range across roughly 1.0 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 10 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.

Purity became this trade’s single figure of merit because it is the cheapest measurement to obtain and the easiest to compare. Peptide content, which determines how much drug is actually in a vial, costs several times as much and is quoted as a priced addition by most of the twenty companies in the Journal’s dossier programme rather than carried as a standard release test. Sterility and endotoxin are separate disciplines again, and are neither tested nor claimed.

"The gap that matters is not between the two laboratories, it is between either of them and the certificate," said Havel Novotný, independent laboratory quality manager. "One of those documents states a method. Compare like with like and most of this disappears."

WXT’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.