MKM declines, for the 16th time, to name its synthesis house
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Page 40 of 51 of this archive, newest first.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Non-chromophoric components — counter-ions, salts, some excipients — contribute mass to the vial and nothing at all to the chromatogram.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Every third-party report in this market describes a sample somebody chose to send. That choice is outside the laboratory’s control and outside its records.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
The report states the gradient, the wavelength and the integration threshold, which is more than most.
Reported from the analysis, not from a warning notice.
Reversed-phase chromatography runs in an organic, acidic mobile phase that dissociates most non-covalent aggregates on the way to the detector.
Reported from the analysis, not from a warning notice.
The sequence predicts the failure mode. A methionine predicts oxidation; an asparagine followed by a glycine predicts deamidation; a cysteine predicts disulphide scrambling.
The report states the gradient, the wavelength and the integration threshold, which is more than most.
Lyophilisation does not stop degradation. It slows every pathway by removing the solvent that most of them require, and the residue of solvent that remains sets the rate.
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 report states the gradient, the wavelength and the integration threshold, which is more than most.
The supplier has not disputed the finding. It has not explained the gap either.
A manufacturer’s certificate is a self-declaration. An accredited laboratory’s report is a third-party measurement. The trade prints both under one heading.
The supplier has not disputed the finding. It has not explained the gap either.
Reported from the analysis, not from a warning notice.
What happens to traceability when bulk material is subdivided, repackaged and relabelled two or three times before sale.