VendorInvestigate result on a Suzhou liraglutide lot lands 4.2 points below the supplier’s figure
The report states the gradient, the wavelength and the integration threshold, which is more than most.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Page 4 of 10 of this archive, newest first.
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.
A brief and unromantic tour of the interface between a liquid sample and a vacuum.
The result is unremarkable. What the report omits is not.
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.
Every step between the laboratory report and the product page removes information, and the badge is the last step.
Bacteriostatic water contains benzyl alcohol at 0.9 per cent, which inhibits microbial growth in a preserved multiple-dose presentation. It does not sterilise a contaminated…
The result is unremarkable. What the report omits is not.
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 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.
What the Journal asks when a document arrives unsigned, and what the answers have been.
The supplier has not disputed the finding. It has not explained the gap either.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
A brief and unromantic tour of the interface between a liquid sample and a vacuum.
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.
Purity, content, identity, sterility and endotoxin are five separate determinations. A single sheet of paper carrying one of them is not evidence about the other four.
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.
Reversed-phase chromatography runs in an organic, acidic mobile phase that dissociates most non-covalent aggregates on the way to the detector.