VendorInvestigate result on a Xianning liraglutide lot lands 2.5 points below the supplier’s figure

VendorInvestigate has released a batch of 23 analytical reports on research-grade liraglutide lots, including material from WXT and SGN. Reported purities range across roughly 2.5 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 4900 vials from the same lot and had 23 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.

The Journal purchased 4900 vials from the same lot and had 23 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.

The wider context is that material sold for research use carries no regulatory release specification in any jurisdiction the Journal has examined. A certificate is a commercial document, not a compliance one, and its content is whatever the issuer chooses to put on it. That is the gap independent testing fills, and it fills it imperfectly.

Rowena Ashcombe, community pharmacist and diabetes educator, was more cautious. "One lot tells you about one lot. I would not draw a conclusion about a company from a single determination, and I would not let a company draw one either."

WXT’s dossier has been updated with this determination and with the date of the request for comment. The dossier’s "what we could not verify" box records the questions still outstanding.