What a 40% rise in coupling-reagent prices does to a 2 mg vial
Follow the resin, not the catalogue.
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.
PeptideMeter has published a purity determination of 98.1% on a 5 mg vial of retatrutide supplied by HJ, against a figure of 94.6% on the certificate that accompanied the vial. The sample was submitted by the Journal in July 2024 as part of a continuing programme of arm’s-length purchasing, and the vendor was told before the order was placed that any result would be published.
Content by elemental nitrogen determination returned 98% of the labelled nominal mass, which on a 5 mg vial corresponds to roughly 9.88 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 98% of the labelled nominal mass, which on a 5 mg vial corresponds to roughly 9.88 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 quoted as a priced addition by most of the twenty companies in the Journal’s dossier programme rather than carried as a standard release test. Sterility and endotoxin are separate disciplines again, and are neither tested nor claimed.
"Ask for the suitability summary before you argue about the percentage," said Havel Novotný, independent laboratory quality manager. "If the tailing factor and the replicate precision are outside limits, you are arguing about arithmetic performed on an unfit separation."HJ’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.
Follow the resin, not the catalogue.
The header identifies the batch, the table records the tests, and the footer says who is answerable. Two of the three are usually incomplete.
The interval between manufacture and analysis is the most under-read figure on the page, and the one most likely to matter by the time a vial is opened.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
The report states the gradient, the wavelength and the integration threshold, which is more than most.