The DSIP endotoxin report for lot CBR-DSP-260403-001 lists a lysate sensitivity of 0.05 EU/mL and a result of less than 5 EU per vial. The first figure describes the test. The second describes the vial.

Albany, United States, October 23, 2026 -- ALBANY, N.Y., Oct. 22, 2026 -- Crescent Bioresearch, a supplier of laboratory compounds, has published the DSIP certificate of analysis for lot CBR-DSP-260403-001. The endotoxin page carries two figures that are often confused with each other: the lysate sensitivity, 0.05 EU/mL, and the endotoxin result, less than 5 EU per vial. The first describes the test. The second describes the vial. The certificate lists each on its own line.

Emideltide (DSIP), the nonapeptide Trp-Ala-Gly-Gly-Asp-Ala-Ser-Gly-Glu (WAGGDASGE), CAS 62568-57-4, is supplied by Crescent Bioresearch as DSIP 15 mg for laboratory research.

Signed BTLabs endotoxin report for DSIP 15 mg, lot CBR-DSP-260403-001, with the sensitivity, result and determination highlighted. Result below 5 EU per vial, threshold 350 EU per vial, lysate sensitivity 0.05 EU/mL, determination PASS. Kinetic turbidimetric LAL, USP 85.

What the DSIP page reports

BTLabs, an independent laboratory in West Palm Beach, Florida, tested the lot on Sept. 24, 2026, by the Limulus amebocyte lysate (LAL) test under USP General Chapter 85, Bacterial Endotoxins Test. The page lists the volume the vial was dissolved in for the test, 2 mL; the endotoxin limit, 350 EU per vial; the lysate sensitivity, 0.05 EU/mL; the endotoxin result, less than 5 EU per vial; and the determination, PASS. The vial holds 15 mg, so the result is less than 0.33 EU per milligram.

What the sensitivity measures

Endotoxin is lipopolysaccharide, the main component of the outer membrane of Gram-negative bacteria. The LAL test detects it with a lysate prepared from horseshoe crab blood cells, and each batch of lysate is labeled with the smallest concentration of endotoxin it can detect. That label is the sensitivity. USP Chapter 85 requires the laboratory to confirm it against a reference standard before any sample is tested, and once confirmed it applies to every sample tested with that lysate. A vial carrying a heavy endotoxin load and a vial carrying almost none would both show 0.05 EU/mL in the sensitivity column, because the sensitivity describes the lysate and has nothing to do with the vial.

How the two figures are confused

Many endotoxin reports in circulation print the sensitivity, the word "pass" and nothing else. The sensitivity is then the only number on the page, and a reader looking for the endotoxin value naturally takes it as that value. On a report of that kind, no endotoxin value was provided at all. The reader has been given the precision of the instrument and the verdict of the laboratory, and has not been given the measurement.

A school exam shows the same thing

A report card says "graded to the nearest point" and "pass," with a passing mark of 70. "Graded to the nearest point" describes how carefully the exam was marked. It is not the student's score. A student who reads it as the score has misread the card.

The DSIP certificate has the same two kinds of numbers. The lysate sensitivity, 0.05 EU/mL, describes the smallest amount the test can detect. The endotoxin result, less than 5 EU per vial, is what was found in the vial. The certificate lists them on separate lines, so one is never taken for the other.

The check a research entity can make on any certificate

The units settle it. A sensitivity is written per milliliter of test solution. A result for a vial is written per vial, or per milligram once the fill is known. When the only number on an endotoxin report is written per milliliter, that number is the sensitivity, and the report contains no result. The DSIP annotated endotoxin report labels both lines.

What the DSIP page lets a research entity do

On the DSIP certificate the sensitivity, 0.05 EU/mL, sits on one line and the result, less than 5 EU per vial, sits on another, with the limit of 350 EU per vial beside it. From those three figures a research entity can confirm the pass, convert the result to less than 0.33 EU per milligram, and hold it against its own requirement. Only the result tells it whether endotoxin could be behind anything it records, so that what it sees can be credited to DSIP itself.

"The sensitivity tells a research entity how fine the test was. The result tells it what is in the vial," Crescent Bioresearch said. "When a report carries only one number, written per milliliter, that number describes the test. The measurement of the vial is missing."

SOURCE DOCUMENTS

Bacterial Endotoxins Test report COA261647-004, issued by BTLabs, West Palm Beach, Florida, for DSIP lot CBR-DSP-260403-001, tested Sept. 24, 2026, by LAL; USP General Chapter 85, Bacterial Endotoxins Test.

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