The fourth question, answered on its own certificate.
Every KMD certificate answers three questions: is it the right compound, how pure is it, and how much is in the vial. HPLC cannot see endotoxin. Now we measure that too, in-house, by kinetic chromogenic LAL (USP <85>), and report it the way we report everything else: a number on a sealed certificate anyone can verify.
$150 per vial, flat. One box on the order form. 5–7 business days from receipt.
Purity does not predict endotoxin.
Endotoxin is what bacteria leave behind. It survives filtration and freeze-drying, and it does not show on a chromatogram. It usually comes from the water, the glass or the process, not the peptide itself. A vial can read 99 percent pure and still carry it. The only way to know is to measure it.
For the people who buy from you, that measurement is the difference between a purity number and a product they can trust. It is also the question we are asked most.
Kinetic chromogenic LAL, USP <85>, run on a Charles River Endosafe cartridge reader in our Chatsworth lab. One cartridge, one sample, one result.
Endotoxin units per mL at the dilution we ran, the reporting limit, the positive product control recovery and the reaction-time precision, all printed.
Its own certificate with its own ID, sealed with a SHA-256 fingerprint and a QR code that opens the public verification page.
This autumn's injectable recalls were endotoxin problems.
| Aug 27 | FDA alert: 30 or more patients with reactions after IV glutathione made from one supplement-grade ingredient lot. |
| Aug – Oct | Four Texas pharmacy recalls of glutathione injections for elevated endotoxin. |
| Sep 11 | CDC investigation: 25 or more illnesses across four states. |
In every case the problem was endotoxin, not purity. Tested before it ships, on a certificate your customers can check themselves, it is a selling point. We bought the instrument rather than send your vials to another lab, because the name on the certificate should be the lab that ran the test.
Three steps. The only new one is the box.
- 1Open the order form. The same form as always. This link opens it with endotoxin already ticked.
- 2Tick the endotoxin box. Under Tests, next to Identity, Purity and Assay. One check adds $150 to that vial.
- 3Ship as usual. Same intake photo, same chain of custody. For a powder, send a second unopened vial of the same lot and write E on it. The result arrives on its own certificate.
The certificate, and the instrument behind it.
Endotoxin testing — FAQ
Do I have to send a second vial?
For a powder, yes: a second, unopened vial of the same lot, marked E. We open one vial for HPLC and the E vial stays sealed until the endotoxin run. Liquids such as bacteriostatic water are tested from the same vial. The order form reminds you at checkout and the shipping email repeats it.
What does the result look like?
Endotoxin units per mL at the dilution we ran, the reporting limit at that dilution, the positive product control recovery and the reaction-time precision, on a one-page certificate with its own ID, a SHA-256 seal and a QR code that opens the public verification page. A reading below the lowest standard prints as below the reporting limit.
Is there a pass or fail?
The certificate reports the measured number and whether the test itself was valid. Any dose limit depends on how the product is used, so that comparison is yours to make; the certificate gives you the number to make it with.
How long does it take?
5–7 business days from the day we log the vial in. Vials that arrive before the first run week are held and run in the first batch.
Can I order endotoxin on its own, for a product you already tested?
Endotoxin is ordered as an add-on on the order form. For an endotoxin-only run on a product we have already tested, email info@kmdanalytical.com with the product and lot and we will invoice it at the same $150 per vial; it needs a fresh, unopened vial of that lot.
Does the price change with volume?
No. $150 per vial, flat, on top of the HPLC price for that vial. Volume rates still apply to the HPLC side of the order.