A supplier suspends shipping to Brazil after 18 consecutive customs detentions
The route did not close because of a rule about peptides.
Testing Dispatch
Medutest result on a Nantong orforglipron lot lands 2.6 points below the supplier’s figure
The report states the gradient, the wavelength and the integration threshold, which is more than most.
Two laboratories analysing vials from the same orforglipron lot have returned figures 2.6 percentage points apart. Medutest reported 97.5%; VendorInvestigate 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.
Content by elemental nitrogen determination returned 84% of the labelled nominal mass, which on a 20 mg vial corresponds to roughly 6.44 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.
Content by elemental nitrogen determination returned 84% of the labelled nominal mass, which on a 20 mg vial corresponds to roughly 6.44 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.
The wider context is that material sold for research use carries no regulatory release specification in any jurisdiction the Journal has examined. A certificate is a commercial document, not a compliance one, and its content is whatever the issuer chooses to put on it. That is the gap independent testing fills, and it fills it imperfectly.
Rowena Ashcombe, community pharmacist and diabetes educator, was more cautious. "One lot tells you about one lot. I would not draw a conclusion about a company from a single determination, and I would not let a company draw one either."
JEEP’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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