Independent analysis puts a SGN cagrilintide lot at 98.0%, against 96.6% on the certificate

A peptide content determination commissioned by the Journal on a 10 mg cagrilintide vial from SGN has returned 98% of the labelled mass. Chromatographic purity on the same vial was above 98.0%. The two numbers measure different things and only one of them was on the certificate.

The Journal purchased 1400 vials from the same lot and had 19 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 1400 vials from the same lot and had 19 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.

Batch variance rather than vendor quality is the recurring finding of this programme. Across the 19 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 Lorcan Feeney, analytical services director at an independent laboratory. "Purity is what you can afford. Content is what you need."

SGN’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.