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Testing Dispatch
Independent analysis puts a WXT semaglutide lot at 98.8%, against 95.3% on the certificate
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
Janoshik has published a purity determination of 98.8% on a 15 mg vial of semaglutide supplied by WXT, against a figure of 95.3% on the certificate that accompanied the vial. The sample was submitted by the Journal in May 2024 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.
The Journal purchased 3400 vials from the same lot and had 5 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.
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.
"The useful thing in that report is not the percentage, it is the system suitability data," said Lorcan Feeney, analytical services director at an independent laboratory. "It is the only part that tells you whether the percentage means anything."
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.
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