LAL, kinetic chromogenic, recombinant factor C: three ways to the same figure
Three compendial method families are in routine use and a fourth, based on a recombinant enzyme rather than crab lysate, is now compendial in its own right.
Testing Dispatch
Independent analysis puts a ERP survodutide lot at 96.4%, against 93.7% on the certificate
The supplier confirmed the determination and supplied the method behind its own figure inside a week.
Two laboratories analysing vials from the same survodutide lot have returned figures 1.1 percentage points apart. Janoshik reported 96.4%; PeptideMeter reported a lower number on a shallower gradient with a tighter integration threshold. Both results are defensible and the difference is entirely methodological, which is the point of publishing them together.
The Journal purchased 9 vials from the same lot at retail and had four 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.
Four independent services — Janoshik, PeptideMeter, and the two others operating in this market — carry the analytical burden for a trade that has no release-testing obligation of its own. Each is paid by whoever submits the sample, which is usually the vendor. The Journal’s position is that a submitter-pays model is workable but that its incentive structure has to be stated whenever a result is quoted as verification.
"The useful thing in that report is not the percentage, it is the system suitability data," said Dr Beatriz Sarmiento, clinical pharmacologist, Universidad de Navarra. "It is the only part that tells you whether the percentage means anything."
ERP’s dossier has been updated with this determination and with the company’s response to it. The dossier’s ordering box records the lead times, the minimum quantities and what a buyer should ask for at the point of order.
Related coverage
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One column, one wavelength, one very large blind spot
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.
The badge economy, and what it is actually certifying
Every step between the laboratory report and the product page removes information, and the badge is the last step.
Janoshik result on a Wuxi survodutide lot lands 2.9 points above the supplier’s stated figure
The supplier confirmed the determination and supplied the method behind its own figure inside a week.