A percentage is not a specification
Chromatographic purity is cheap, fast and comparable-looking. Those three properties, and not its usefulness, explain why it became the industry’s single figure of merit.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Page 51 of 51 of this archive, newest first.
Chromatographic purity is cheap, fast and comparable-looking. Those three properties, and not its usefulness, explain why it became the industry’s single figure of merit.
A short audit procedure, usable by anyone holding a certificate and a calculator.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
Two years ago we ran an anonymised version of this comparison and promised a named one. This is it, with every method printed in full.
Reported from the analysis, not from a warning notice.
The supplier has not disputed the finding. It has not explained the gap either.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
We submitted vials for endotoxin determination and report the results, the method and the laboratory, because a pyrogen figure without a method is as empty as a purity…
The header identifies the batch, the table records the tests, and the footer says who is answerable. Two of the three are usually incomplete.
A reminder that a purity figure is the output of a method, and that methods differ.
Chain of custody, in a regulated setting, begins at sampling. Here it begins when the package arrives.
Reported from the analysis, not from a warning notice.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Reported from the analysis, not from a warning notice.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
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.
The supplier has not disputed the finding. It has not explained the gap either.
A result on one vial generalises to a batch only if the vial was drawn in a way that makes it representative — and nobody records how it was drawn.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.