HJ declines, for the 18th time, to name its synthesis house
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Testing Dispatch
A reminder that a purity figure is the output of a method, and that methods differ.
A peptide content determination commissioned by the Journal on a 30 mg mazdutide vial from SGN has returned 89% of the labelled mass. Chromatographic purity on the same vial was above 95.3%. The two numbers measure different things and only one of them was on the certificate.
Reported figures across the set were: highest 95.3%, lowest 94.5%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 9 of them stated an integration threshold. The Journal has asked the laboratory to publish thresholds on all reports as a matter of routine.
Content by elemental nitrogen determination returned 89% of the labelled nominal mass, which on a 30 mg vial corresponds to roughly 5.06 mg of peptide rather than the labelled figure. The remainder is accounted for by counter-ion, residual water and residual solvent, none of which is visible chromatographically.
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 not offered as a standard release test by any of the twenty companies in the Journal’s dossier programme. Sterility and endotoxin are separate disciplines again, and are neither tested nor claimed.
"The figure is not wrong and neither is theirs," said Rowena Ashcombe, community pharmacist and diabetes educator. "They are answers to two different questions and the trade has decided to pretend there is only one question. Print the gradient and the argument disappears."
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.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
A manufacturer’s certificate is a self-declaration. An accredited laboratory’s report is a third-party measurement. The trade prints both under one heading.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
We asked twenty companies three questions about stability data and print every answer, refusal and non-response.
The Journal has read several hundred certificates from twenty companies. We set out what the documents actually cover, and what a reader is filling in from imagination.