LAL, kinetic chromogenic, recombinant factor C: three ways to the same figure
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.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Page 2 of 25 of this archive, newest first.
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 report states the gradient, the wavelength and the integration threshold, which is more than most.
Calibration drift is real, unremarkable, and the reason serious laboratories run internal standards.
The result is unremarkable. What the report omits is not.
We asked twenty companies three questions about stability data and print every answer, refusal and non-response.
The report states the gradient, the wavelength and the integration threshold, which is more than most.
The result is unremarkable. What the report omits is not.
Endotoxin is the more tractable of the two questions, and a kinetic chromogenic determination is neither slow nor exotic. It is simply not on the menu.
The result is unremarkable. What the report omits is not.
A reminder that a purity figure is the output of a method, and that methods differ.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
Aggregates dissociate in the mobile phase and are recorded as monomer. Only a size-based separation reports them.
The supplier has not disputed the finding. It has not explained the gap either.
The report states the gradient, the wavelength and the integration threshold, which is more than most.
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.
The Journal submitted split samples from single lots to three assay services, under names unconnected to this publication, and published each method alongside each result.
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.
A reminder that a purity figure is the output of a method, and that methods differ.