USP <85> bacterial endotoxin testing for compounding pharmacies including 503A and 503B facilities. LAL-based BET with full inhibition/enhancement validation.
USP <85> bacterial endotoxin testing is a required quality attribute for sterile compounded preparations.
503B facilities operate under cGMP and require BET as part of finished product release testing.
Parenteral, ophthalmic, and intrathecal preparations have the strictest endotoxin limits due to route of administration.
Our 3–5 day turnaround supports timely batch release without exceeding beyond-use dating.
All testing follows USP <85> methodology including PPC, NPC, and inhibition/enhancement controls.
Full USP <85> compliant documentation.
Submitting takes less than 5 minutes. Most projects turn around in 5–10 business days from sample receipt.
Fill out our sample intake form — sample type, quantity, and timeline. We confirm turnaround and quote within one business day.
We'll send submission instructions and our San Diego shipping address. Most samples ship ambient or cold depending on stability requirements.
Results are delivered as a signed PDF COA within the agreed turnaround. Rush service (2–3 business days) available for urgent timelines.
Limits depend on the route of administration. Parenteral preparations typically have a limit of 5 EU/kg/hr for IV dosing, calculated from your dose. We can help you derive the product-specific limit from your formulation data.
Yes. Method suitability testing (inhibition/enhancement) is included with every sample to confirm the assay is valid for your specific formulation matrix.
Yes. We can work with small sample volumes typical in compounding — contact us with your specific volume constraints.
Submit your samples and receive an ISO 17025 accreditation pending Certificate of Analysis. Results in 5–10 business days.