Independent analysis puts a SSA dulaglutide lot at 96.0%, against 95.0% on the certificate

Janoshik has published a purity determination of 96.0% on a 10 mg vial of dulaglutide supplied by SSA, against a figure of 95.0% on the certificate that accompanied the vial. The sample was submitted by the Journal in August 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.

The Journal purchased 900 vials from the same lot and had 20 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.

Reported figures across the set were: highest 96.0%, lowest 95.0%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 20 of them stated an integration threshold. The Journal has asked the laboratory to publish thresholds on all reports as a matter of routine.

Batch variance rather than vendor quality is the recurring finding of this programme. Across the 20 determinations the Journal has commissioned to date, within-vendor spread has been wider than between-vendor spread for two thirds of the companies tracked, which is an argument against rating any supplier on a single number.

"Content is the number that matters if you are doing arithmetic with a vial, and content is the number nobody sells," said Yusuf Kandemir, freight and customs broker, Istanbul. "Purity is what you can afford. Content is what you need."

SSA’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.