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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 dose and route
Acceptable endotoxin limits are set to comply with USP <85>, which calculates them from the patient's dose and route of administration.
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 1 vial 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).
1 vial per timepoint
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.
OUR SERVICES
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STABILITY STUDIES
Planning a stability study?
See how this test can support a validated stability program and the data needed for extended beyond-use dating.
✓
Stability-indicating HPLC methods that separate API from degradation products
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Custom study designs for refrigerated, frozen and room-temperature storage conditions
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Defined pull points with potency, pH, appearance and container-closure assessment
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Documentation packages to support extended beyond-use dating under USP <797>
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Sterility and endotoxin testing integrated at study end points
Guide: USP <797> stability studies & extended beyond-use dating →
Request a Stability Study Quote
Starting at $10,000
CATEGORY 2
CATEGORY 3
These studies generate the stability data required to qualify for the extended beyond-use dates that USP <797> permits for Category 2 and Category 3 CSPs — going well beyond the default short-dating limits.
TYPICAL STUDY OUTLINE
What a stability program covers
Supports
USP <797> Cat 2 & Cat 3 extended BUD
Storage conditions
Refrigerated · Frozen · Controlled RT
Pull points
T0, then defined intervals to BUD
Assays per point
Potency · pH · Appearance
Method type
Stability-indicating HPLC
End-point testing
Sterility · Endotoxin
Deliverable
BUD support documentation
COMMON QUESTIONS
Frequently Asked Questions
RELATED INFO
Relevant Resources
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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 methods verified for suitability, alternatives validated
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
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