What the four services actually offer, test by test
We asked all four services what they can determine, on what timescale, at what price, and under what accreditation. The answers are printed in full.
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 10 mg cagrilintide vial from JEEP has returned 94% of the labelled mass. Chromatographic purity on the same vial was above 95.9%. The two numbers measure different things and only one of them was on the certificate.
Reported figures across the set were: highest 95.9%, lowest 93.0%, median close to the midpoint of the two. Every report in the set stated a detection wavelength, and 7 of them stated an integration threshold. The Journal has asked the laboratory to publish thresholds on all reports as a matter of routine.
Discrepancies of one to two percentage points between a supplier’s figure and an independent determination are common and usually explicable: a faster gradient resolves fewer impurities, a higher integration threshold discards more small peaks, and a wider solvent-front exclusion window removes early-eluting fragments from the calculation altogether. None of that is misconduct. All of it is invisible unless the method is disclosed.
"The useful thing in that report is not the percentage, it is the system suitability data," said Rowena Ashcombe, community pharmacist and diabetes educator. "It is the only part that tells you whether the percentage means anything."
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.
We asked all four services what they can determine, on what timescale, at what price, and under what accreditation. The answers are printed in full.
A retest date says that material should be re-examined before use. An expiry date says it should not be used. The trade uses the second word for the first concept.
A compendial sterility test takes fourteen days of incubation and consumes the containers tested. That timescale is incompatible with the business model that made…
Every step between the laboratory report and the product page removes information, and the badge is the last step.
Duplicate submissions under different names test within-laboratory repeatability, which is a different quantity from between-laboratory reproducibility.
The Journal submitted split samples from single lots to three assay services, under names unconnected to this publication, and published each method alongside each result.