Independent analysis puts a SGN dulaglutide lot at 96.0%, against 93.3% on the certificate
The supplier has not disputed the finding. It has not explained the gap either.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Page 5 of 25 of this archive, newest first.
The supplier has not disputed the finding. It has not explained the gap either.
What happens to traceability when bulk material is subdivided, repackaged and relabelled two or three times before sale.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
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 Journal submitted the sample and paid for the analysis. The vendor was told in advance.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
We submitted vials for endotoxin determination and report the results, the method and the laboratory, because a pyrogen figure without a method is as empty as a purity…
A badge asserts that something was tested. It does not assert what, when, on whose sample, by what method, or whether the lot on sale is the lot that was tested.
The report states the gradient, the wavelength and the integration threshold, which is more than most.
A reminder that a purity figure is the output of a method, and that methods differ.
Two years ago we ran an anonymised version of this comparison and promised a named one. This is it, with every method printed in full.
A chromatogram is silent on everything that does not absorb: counter-ions, water, inorganic salts and non-chromophoric excipients all contribute mass to the vial and nothing…
Accreditation is granted for a defined scope of methods. A laboratory can be properly accredited and the test on your certificate can sit outside it.
A reminder that a purity figure is the output of a method, and that methods differ.
Every step between the laboratory report and the product page removes information, and the badge is the last step.
What happens to traceability when bulk material is subdivided, repackaged and relabelled two or three times before sale.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
Stereochemical inversion changes the molecule, changes its biology, and changes its mass by exactly nothing.
A document is only as good as the chain that connects it to the material, and most chains here are two or three links longer than the paperwork admits.