The Crescent Foundation / The difference
Testing is common across the laboratory compound sector. A record that can be examined is not. These are the six places the two part ways.
Side by side
Switch between common practice and the Crescent standard.
Line by line
Common practiceOften reported as PASS alone, or not at all.
The Crescent standardThe measured value or bound in a stated unit, with the limit, the lysate sensitivity and the volume.
A pass cannot be checked against a stricter criterion. A number can, and the volume turns it into the total in the vial. See it
Common practiceOften in-house, or a laboratory left unnamed.
The Crescent standardAn independent third-party laboratory, named on the certificate.
A named laboratory can be contacted and its report number traced. An unnamed one cannot. See it
Common practiceAt times, one document reused across batches.
The Crescent standardOne certificate per lot, matched to the number on the vial.
A certificate describes the sample that was tested. Matched lot numbers are the only proof that the vial in hand is that sample. See it
Common practiceOften available only on request.
The Crescent standardPublished before the lot is listed.
A research entity can read the record before it buys, not after it asks. See it
Common practiceMethod often unstated.
The Crescent standardThe USP chapter stated for every test.
The chapter tells the reader how the figure was produced and how it should be read. See it
Common practiceEarlier certificates often removed.
The Crescent standardSuperseded certificates kept public.
Any vial still on a bench can be traced to the measurements made on its own lot. See it
The evidence
On Oct. 1, Crescent Bioresearch read 25 certificates of analysis posted publicly by 25 sellers of laboratory compounds and recorded how each reported bacterial endotoxin.
printed a measured endotoxin value
printed a ceiling written with a “less than” sign
printed a pass or a fail with no measured value
carried no endotoxin result at all
None reported endotoxin per vial. Two printed the sensitivity of the lysate, both beside a pass with no value.
Every Crescent certificate is published under its lot number.
THE CRESCENT FOUNDATION