Japan health authority warns on falsified exenatide pens
Reported from the analysis, not from a warning notice.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
Page 31 of 51 of this archive, newest first.
Reported from the analysis, not from a warning notice.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
Storage instructions in this market are close to uniform and almost never accompanied by the study that would justify them. Uniformity is a sign of convention, not of…
The supplier has not disputed the finding. It has not explained the gap either.
The compendial sterility test cannot demonstrate that a batch is sterile. It can only fail a batch that is grossly contaminated. Everything else is process validation.
What happens to traceability when bulk material is subdivided, repackaged and relabelled two or three times before sale.
Reported from the analysis, not from a warning notice.
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 result is unremarkable. What the report omits is not.
The Journal submitted the sample and paid for the analysis. The vendor was told in advance.
The honest finding is more nuanced than the alarm: a lyophilised cake tolerates a brief warm excursion far better than a reconstituted solution does, and the trade’s real…
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.
Reported from the analysis, not from a warning notice.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Reported from the analysis, not from a warning notice.
The absences are not concealment. They are the form the trade settled on, and no buyer has ever objected.