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Endotoxin Testing
USP <85> bacterial endotoxin testing (LAL) for patient-safety release.
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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 maximum dose volume
During Method Suitability we set the acceptable endotoxin limit compliant with USP <85> ||| <85> sets the acceptable endotoxin level from the patient's dose and route, matching safety to how the product is actually given. <<<< NEEDS revision
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.
1 vial
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.
1 vial
Stability Studies
Across your stability timeline
The same test run at each stability timepoint — for example, to support a longer beyond-use date (BUD).
1 vial
TECHNOLOGY
A reagent that reacts with endotoxins.
01
Dilute to appropriate range
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 endotoxins present, a faster reaction means more endotoxins present.
03
Compare to the limit
The result is calibrated against a standard curve and checked against the product's dose-based endotoxin limit.
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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
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