Bacterial Endotoxin Testing | LAL and rFC | USP 85 | NABL Accredited | Auriga Research
Bacterial endotoxin testing (BET) is a critical safety release test for all parenteral pharmaceuticals, ophthalmic preparations, intrathecal products, dialysis solutions, implantable medical devices, water for injection (WFI), and any raw material that names a pyrogen or endotoxin limit. Endotoxins — lipopolysaccharides from gram-negative bacterial cell walls — can trigger severe pyrogenic reactions, septic shock, and organ failure in patients at nanogram levels. Auriga Research operates an NABL-accredited BET laboratory with dedicated depyrogenated glassware, LAL-grade water systems, validated kinetic and gel-clot platforms, and a recombinant Factor C (rFC) animal-free pathway.
All three pharmacopoeial LAL methods are available: gel-clot (limit and semi-quantitative endpoint), kinetic turbidimetric (KTA), and kinetic chromogenic (KCA). Each is validated per USP 85, EP 2.6.14, IP 2.2.3, BP Appendix XIV C, JP 4.01, and ICH Q4B Annex 14. Inhibition and enhancement testing confirms absence of interfering factors for the specific sample matrix. The maximum valid dilution (MVD) is calculated per pharmacopoeial requirements and reported on every BET certificate. Recombinant Factor C (rFC) assays per USP 1085.1 are offered as an animal-free alternative for clients with 3R, ESG, or sustainability commitments.
Testing is delivered across three labs — routine BET screening at Delhi HQ (Arbro Analytical Division) and Bangalore (USFDA Inspected), and method suitability and validation at Manesar (Plot 136, Sector 5, IMT Manesar) — the USFDA Inspected facility. NABL-accredited (ISO/IEC 17025:2017) BET reports are accepted by CDSCO, USFDA, EMA, WHO PQ, UK MHRA, and PMDA without re-testing. International samples are accepted on a chain-of-custody basis with DDP shipping support.
Six Bacterial Endotoxin Testing Services
Each card maps the test type to the analytical method, the governing pharmacopoeial reference, and the Auriga lab where it is performed.
LAL Gel-Clot Test
Qualitative limit and semi-quantitative endpoint LAL gel-clot per USP 85, EP 2.6.14, IP 2.2.3, BP Appendix XIV C, JP 4.01, and ICH Q4B Annex 14. Routine testing at Delhi and Bangalore.
Turbidimetric LAL Test
Kinetic turbidimetric assay (KTA) — quantitative LAL endotoxin determination per USP 85 and EP 2.6.14. Suited to high-volume routine release testing. Delhi and Bangalore.
Chromogenic LAL Test
Kinetic chromogenic assay (KCA) — quantitative LAL endotoxin determination per USP 85 and EP 2.6.14. Preferred for difficult matrices and interference cases. Delhi and Bangalore.
rFC (Recombinant Factor C) Test
Animal-free fluorogenic endotoxin detection per USP 1085.1. Functionally equivalent to LAL with no horseshoe crab reagent. Supports 3R, ESG, and sustainability policies.
Method Suitability and Validation for BET
Inhibition and enhancement validation, maximum valid dilution (MVD), specificity, accuracy, precision, LOD, LOQ, and robustness. Full ICH Q2(R2) validation package on request. Conducted at Manesar (USFDA Inspected).
International Samples with Chain-of-Custody
Inbound sample receipt with chain-of-custody documentation and DDP shipping support. NABL reports formatted for USFDA, EMA, WHO PQ, UK MHRA, and PMDA dossier submission.
LAL vs rFC — Both Available in One Lab
Auriga is a single-vendor source for both traditional LAL methods (gel-clot, KTA, KCA per USP 85) and animal-free rFC (recombinant Factor C per USP 1085.1). Clients running both methods during a method-transfer or LAL-to-rFC comparability study can do so in the same accredited lab, with the same QA team, and against the same product specification. ICH Q4B Annex 14 confirms LAL pharmacopoeial harmonisation across USP, EP, IP, BP, and JP; rFC acceptance is established under USP 1085.1 and EP 2.6.32.
Project Timelines
Indicative TAT from sample receipt at Delhi, Bangalore, or Manesar. Confirm exact timeline with your SPOC at quote stage based on method, matrix, and sample queue.
| Service Type | Turnaround Time |
|---|---|
| Standard BET (established method) | 3 to 5 business days |
| Rush BET (urgent release) | 1 to 2 business days |
| Method Suitability (inhibition / enhancement) | 5 to 7 business days |
| Full Method Validation (dossier-grade) | 2 to 3 weeks |
| Water System Monitoring (WFI / PW) | 2 to 3 business days |
How It Works
Get a Quote
Share your product type, pharmacopoeial specification (USP, EP, or IP), and whether you need LAL or rFC. Your SPOC confirms sample volume, container requirements, and TAT.
Collect and Send Your Sample
Prepare your sample per instructions confirmed by your SPOC at quote stage. Each sample is bar coded and registered in YLIMS on receipt.
Testing and QA Review
Your sample is tested under NABL-accredited conditions. All results pass through formal QA review including instrument log check, reference standard verification, and analyst sign-off.
Receive Your NABL Report
Your NABL-accredited report is delivered digitally within the committed TAT, formatted for CDSCO, USFDA, and regulatory submission. Track status via YLIMS.
Who Needs Bacterial Endotoxin Testing
- Manufacturers of injectables, parenterals, and medical devices requiring endotoxin release testing per USP 85, EP 2.6.14, IP 2.2.3, or ISO 10993-12.
- API manufacturers submitting CDSCO or USFDA dossiers requiring BET data in the drug master file (DMF) and product specification.
- Biotech and biologic product manufacturers requiring rFC as an animal-free alternative to LAL — supporting 3R, ESG, and sustainability commitments.
- International clients sending samples to a NABL and USFDA Inspected lab for dossier support, MA renewal, or post-approval change submissions.
- Medical device manufacturers requiring endotoxin testing of device extracts prepared per ISO 10993-12 sample preparation protocols.
- Pharmaceutical water system owners (WFI, purified water, highly purified water) requiring routine endotoxin monitoring per USP 1231 expectations.
- Ophthalmic, intrathecal, and dialysis solution manufacturers where endotoxin limits are tighter than standard parenteral limits.
- Companies running LAL-to-rFC method comparability or switching their BET specification — method suitability validation conducted at Manesar.
Why Auriga for Bacterial Endotoxin Testing
LAL and rFC Both Available in One Lab
Single-vendor source for traditional LAL (gel-clot, KTA, KCA per USP 85) and animal-free rFC (USP 1085.1). Run both methods during a comparability study without splitting samples between two labs.
USFDA Inspected at Manesar and Bangalore
BET data generated at Manesar and Bangalore is accepted in USFDA submissions. Method suitability and validation conducted at the USFDA Inspected Manesar facility.
NABL Reports Accepted by CDSCO, USFDA, EMA, WHO
NABL accredited (ISO/IEC 17025:2017) BET reports accepted by CDSCO, USFDA, EMA, WHO PQ, UK MHRA, and PMDA without re-testing. Reports formatted to the cited pharmacopoeial reference.
All Pharmacopoeial Methods in Scope
USP 85, EP 2.6.14, IP 2.2.3, BP Appendix XIV C, JP 4.01, and ICH Q4B Annex 14 — the harmonised global BET framework — covered under one accreditation scope.
Method Suitability + Validation Capability
Full inhibition and enhancement validation, MVD calculation, and ICH Q2(R2) method validation packages for product-specific dossier submission, delivered from Manesar.
International Sample Handling with DDP
Inbound chain-of-custody documentation and DDP shipping support for global clients. NABL reports formatted for direct inclusion in USFDA, EMA, and PMDA submissions.
5+
NABL Accredited Labs
5 Cities
Delhi · Manesar · Bahadurgarh · Baddi · Bangalore
12,000+
Clients Served
1985
Arbro Group · Auriga Research
Regulatory References
- • USP <85> — Bacterial Endotoxins Test (current US Pharmacopoeia).
- • EP 2.6.14 — Bacterial Endotoxins (European Pharmacopoeia).
- • IP 2.2.3 — Bacterial Endotoxins (Indian Pharmacopoeia).
- • BP Appendix XIV C — British Pharmacopoeia BET.
- • JP 4.01 — Japanese Pharmacopoeia BET.
- • ICH Q4B Annex 14 — Pharmacopoeial harmonisation of BET methods.
- • USP <1085.1> — Recombinant Factor C (rFC) as animal-free alternative.
- • ISO 10993-12 — Sample preparation for endotoxin testing of medical device extracts.
- • ICH Q2(R2) — Validation of Analytical Procedures (March 2024).