Independent analysis puts a HJ exenatide lot at 98.4%, against 97.3% on the certificate
The report states the gradient, the wavelength and the integration threshold, which is more than most.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Page 28 of 51 of this archive, newest first.
The report states the gradient, the wavelength and the integration threshold, which is more than most.
Bioburden entering the filter, filter integrity, environmental monitoring and aseptic process simulation are the four pillars. The trade documents none of them.
A reminder that a purity figure is the output of a method, and that methods differ.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
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.
The result is unremarkable. What the report omits is not.
An orthogonal method separates on a different physical principle, so that species co-eluting in the first are likely to resolve in the second. Two runs of the same method at…
The result is unremarkable. What the report omits is not.
The report states the gradient, the wavelength and the integration threshold, which is more than most.
What would be needed to catch each of these, and what it would cost.
Reported from the analysis, not from a warning notice.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
The result is unremarkable. What the report omits is not.
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.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
A reminder that a purity figure is the output of a method, and that methods differ.
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 two ionisation techniques in general use produce different charge distributions, different adducts and different failure modes. Certificates almost never say which was…
The report states the gradient, the wavelength and the integration threshold, which is more than most.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.