NOW OFFERING
Endotoxin Testing
USP <85> bacterial endotoxin testing (LAL) for patient-safety release.
View Testing Services
Compendial standard this method is validated to.
Business days from sample receipt to report.
Compounded formulations supported to date.
WHY YOU NEED IT
Why Endotoxin Testing Matters
Prevent pyrogenic reactions
Bacterial endotoxins can cause fever and, at higher doses, septic shock — even in a sterile product. USP <85> confirms levels stay below safe limits.
Sterile isn't the same as safe
Endotoxins are heat-stable and survive sterilization, so a product can pass sterility yet still need a separate endotoxin (LAL) test.
Limits tied to the dose
<85> sets the acceptable endotoxin level from the patient's dose and route, matching safety to how the product is actually given.
OUR PROCESS
How we run this test for you
METHOD SUITABILITY
Proving the method first
Before any lot release, we validate that the test method performs reliably for your product — the compliance step that comes first.
Typically 2 vials per study
LOT RELEASE
Releasing every batch
Our core service — we run the test on each lot so you can release the batch to patients with confidence.
Typically 1 vial per lot
STABILITY STUDIES
Across your stability timeline
The same test run at each stability timepoint — for example, to support a longer beyond-use date (BUD).
Usually [X] vials per timepoint
TECHNOLOGY
A reagent that reacts to endotoxin.
01
Dilute out interference
The sample is diluted below its maximum valid dilution so the assay isn't masked while low endotoxin levels stay detectable.
02
LAL reaction
Limulus amebocyte lysate reacts with any endotoxin present, producing a signal proportional to the amount.
03
Compare to the limit
The result is read off a standard curve and checked against the product's dose-based endotoxin limit.
Other services
TALK TO A SCIENTIST
Tell us what you need tested
Whether you need testing guidance, a quote, or just have questions — we’re here. A scientist will follow up within one business day.
USP-compliant, validated methods
Response within one business day
No obligation — guidance and quotes welcome
For service requests, quotes, or technical questions, email our support team.
info@saphobio.com
Phone
Available Monday to Friday, 9:00 AM – 6:00 PM (Pacific Time).
Text us: +1 (929) 437-6148
Site Visit
Visits by appointment only. Please contact us to schedule.
1068 Washington St. STE B, San Carlos, CA 94070
1068 Washington St Ste B, San Carlos, CA 94070
Follow us on LinkedIn
© 2026 SAPHO BIO. All rights reserved.