Journal Compound
Reporting on incretins, compounding & the peptide supply chain
Page 2 of 7 of this archive, newest first.
Four independent services underpin confidence in this market. All four are competent at chemistry. Microbiology is a different accreditation, a different facility and a…
A unit is a volume. A dose is a mass. The bridge between them is concentration, and concentration is a number somebody has to calculate.
Bacterial endotoxin is a heat-stable lipopolysaccharide from the outer membrane of Gram-negative organisms. It survives sterilisation, passes a sterilising filter, and is…
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…
The recurring errors in this market are not exotic. They are a small set of arithmetic and reading failures, each capable of moving a dose by a factor of two or ten.
Four independent services underpin confidence in this market. All four are competent at chemistry. Microbiology is a different accreditation, a different facility and a…
A compendial sterility test takes fourteen days of incubation and consumes the containers tested. That timescale is incompatible with the business model that made…
Longer needles reach muscle in lean limbs, and intramuscular delivery of a long-acting depot changes absorption in ways nobody wants.
Four independent services underpin confidence in this market. All four are competent at chemistry. Microbiology is a different accreditation, a different facility and a…
A compendial sterility test takes fourteen days of incubation and consumes the containers tested. That timescale is incompatible with the business model that made…
Every time a vial changes, the conversion must be recalculated. Carrying forward a unit count from the last vial is the single most reliable way to give the wrong dose.
The evidence base here is the insulin injection-technique literature, which is large and transfers well on tissue questions.
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 masking phenomenon known as low endotoxin recovery means a formulation can return a clean result while containing endotoxin the assay cannot see.
A needle blunts on first use. Reuse is uncomfortable, and it is a documented contributor to lipohypertrophy.
A pharmacist catches most of these in licensed practice. In this market there is no pharmacist, so the checks have to be structural.
The masking phenomenon known as low endotoxin recovery means a formulation can return a clean result while containing endotoxin the assay cannot see.
The air shot before a pen injection removes air from the cartridge and confirms flow. Skipping it can mean a materially reduced dose, and it is skipped constantly.
A sterile product is sterile only for as long as its container closure system excludes the outside world. Integrity is testable, and the tests are cheap by the standards of…
Skin thickness at the standard injection sites is approximately two millimetres in adults and varies remarkably little with body mass. That single finding is why short…