TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
HPLC, mass spectrometry, and the certificate of analysis.
The Journal has read several hundred certificates from twenty companies. We set out what the documents actually cover, and what a reader is filling in from imagination.
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.
A reminder that a purity figure is the output of a method, and that methods differ.
An in-use period is established by a dedicated study on a specific formulation in a specific container at a specific concentration. Borrowing one from a marketed product is…
The result is unremarkable. What the report states alongside it is not.
The two ionisation techniques in general use produce different charge distributions, different adducts and different failure modes. Certificates almost never say which was…
The result is unremarkable. What the report states alongside it is not.
A reminder that a purity figure is the output of a method, and that methods differ.
Reversed-phase chromatography runs in an organic, acidic mobile phase that dissociates most non-covalent aggregates on the way to the detector.
The supplier confirmed the determination and supplied the method behind its own figure inside a week.
Lot-level verification with a public report is a real and achievable thing. It exists in this market, on a minority of listings.
Every degradation pathway accelerates by orders of magnitude on reconstitution, because the solvent that lyophilisation removed is the reagent most of them need.
A reminder that a purity figure is the output of a method, and that methods differ.
What happens to traceability when bulk material is subdivided, repackaged and relabelled two or three times before sale.
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 supplier confirmed the determination and supplied the method behind its own figure inside a week.
The report states the gradient, the wavelength and the integration threshold, which is more than most.
What would make a difference is not a regulator. It is three lines on a certificate, all of which are already known to whoever wrote it.
The result is unremarkable. What the report states alongside it is not.
The report states the gradient, the wavelength and the integration threshold, which is more than most.