The first report
On June 30, 2026, Freedom Diagnostics returned an endotoxin report for NAD+ lot CBR-NAD-260411-001. It listed two replicate lines, each reading Pass, each beside an assay sensitivity of 0.05 EU/mL or less. A field headed Endotoxin Threshold also read Pass. No endotoxin value appeared in any unit, and no numerical threshold appeared anywhere on the page.
The question that went unanswered
Crescent Bioresearch asked the laboratory for the two figures a pass is supposed to stand for: the measured value and the threshold it was compared with. Even when asked directly, and in multiple ways, the laboratory was not able to provide a clear answer for either.
The second report
On Oct. 9, 2026, BTLabs in West Palm Beach, Florida, tested the same lot by the Bacterial Endotoxins Test under USP <85>. Its report states a limit of 350 EU per vial, a lysate sensitivity of 0.05 EU/mL, a test volume of 2 mL and a result of 92.7 EU per vial. The verdict is the same: pass.
What the number adds
The verdict did not change. What changed is what a reader can do with it. A result of 92.7 against a limit of 350 places the lot at about 26 percent of its threshold. Across the 1,000 mg fill, it comes to about 0.09 EU per milligram, a figure a research entity can carry into its own calculation and set against its own limit, as the investigators in a 2024 cell-culture case had to. A pass cannot be converted into any of these.
Why the first report could not be checked
The only figure on the first report, the assay sensitivity, describes the test rather than the vial. It is the lowest concentration the method can detect, and it is often mistaken for the result. A pass printed beside it shows that a test was named, not what it found. Without the value and the threshold, neither a reader nor a second laboratory can confirm how the pass was reached.
What to look for on any certificate
A complete endotoxin report carries three figures, each with its unit: the endotoxin value, the threshold it was judged against, and the sensitivity of the test. It names the laboratory and a report number that the laboratory can confirm. Where the reporting laboratory's integrity is unknown, its ISO/IEC 17025 accreditation can be checked in the public directories of accreditation bodies such as A2LA, ANAB and PJLA, and a sample can be sent to a second laboratory to compare the figures.
See both reports
Both certificates are published in full, side by side, at crescentbioresearch.com/coa/CBR-NAD-260411-001/vs.
Sources
- endotoxin report for lot CBR-NAD-260411-001, Freedom Diagnostics, reported June 30, 2026; BTLabs report COA261889-001, Bacterial Endotoxins Test, USP <85>, tested Oct. 9, 2026.