Accuracy, precision and the tolerance nobody states
Parts per million sound impressive until they are converted into daltons at the molecular weight of the thing being measured.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Identity confirmation by mass, and the difference between a mass that matches and a sequence that is confirmed.
Parts per million sound impressive until they are converted into daltons at the molecular weight of the thing being measured.
Deamidation adds 0.98 daltons. On a low-resolution instrument at incretin molecular weights, that is inside the noise.
The Journal’s standing position: a mass that matches is necessary evidence of identity and nowhere near sufficient.
Every instrument specification quoted in an advertisement is a best case obtained on a calibration mixture, not on a submitted vial.
Calibration drift is real, unremarkable, and the reason serious laboratories run internal standards.
Aggregates dissociate in the mobile phase and are recorded as monomer. Only a size-based separation reports them.
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…
A peptide has a monoisotopic mass and an average mass, they differ by several daltons at this molecular size, and a certificate that does not say which it quotes cannot be…
Aggregates dissociate in the mobile phase and are recorded as monomer. Only a size-based separation reports them.
Accreditation to the international competence standard covers the scope a laboratory has been assessed for, which is not necessarily the test you commissioned.
What would be needed to catch each of these, and what it would cost.
The ionisation method determines the charge states you see, the adducts you must account for, and the modifications you might destroy in the process.
The Journal’s standing position: a mass that matches is necessary evidence of identity and nowhere near sufficient.
Matching a retention time against a standard is evidence of consistency, not proof of identity. Two different species can elute at the same time on one method.
The most useful single addition to any purity determination is a second separation under a different pH or on a different stationary phase, and the second-most useful is a…
Aggregates dissociate in the mobile phase and are recorded as monomer. Only a size-based separation reports them.
Calibration drift is real, unremarkable, and the reason serious laboratories run internal standards.
The Journal has read several hundred certificates from twenty companies. The number is almost always there; the method behind it almost never is.
The Journal’s standing position: a mass that matches is necessary evidence of identity and nowhere near sufficient.
Stereochemical inversion changes the molecule, changes its biology, and changes its mass by exactly nothing.