Before anything is weighed, the peptide has to be charged
A brief and unromantic tour of the interface between a liquid sample and a vacuum.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Page 16 of 27 of this archive, newest first.
A brief and unromantic tour of the interface between a liquid sample and a vacuum.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
Duplicate submissions under different names test within-laboratory repeatability, which is a different quantity from between-laboratory reproducibility.
The supplier has not disputed the finding. It has not explained the gap either.
The supplier has not disputed the finding. It has not explained the gap either.
The limit for a parenteral product is calculable from the dose and the body weight in two lines. Almost nobody in this trade performs the calculation.
The result is unremarkable. What the report omits is not.
What the Journal asks when a document arrives unsigned, and what the answers have been.
A result without a specification is a number. A specification without a result is a promise. Certificates in this market frequently carry one and not the other.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
The result is unremarkable. What the report omits is not.
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.
An intact mass measurement establishes elemental composition, at best. The number of distinct sequences consistent with a given composition is astronomically large.
The compendial sterility test cannot demonstrate that a batch is sterile. It can only fail a batch that is grossly contaminated. Everything else is process validation.
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.
The supplier has not disputed the finding. It has not explained the gap either.
The absences are not concealment. They are the form the trade settled on, and no buyer has ever objected.
Area per cent silently assumes that every species in the sample absorbs as strongly per unit mass as the parent. For peptide impurities that assumption is usually wrong, and…
Every certificate circulating in this market answers a question about molecules. Almost none answers a question about organisms, pyrogens, or the integrity of the seal.