NABL Accredited · Microbiological Testing Laboratory

Bacterial Endotoxin Testing (LAL) India | NABL Accredited

Bacterial endotoxin testing (BET) using LAL methods from an NABL-accredited pharmaceutical laboratory in India.

Bacterial endotoxin testing is a critical safety test for all parenteral pharmaceutical products, ophthalmic preparations, and medical devices. Endotoxins — lipopolysaccharides from gram-negative bacterial cell walls — can trigger severe pyrogenic reactions in patients even at nanogram levels. Auriga Research operates an NABL-accredited BET laboratory with dedicated depyrogenated glassware, LAL-grade water systems, and validated kinetic and gel-clot testing platforms.

Our laboratory performs all pharmacopoeial LAL methods: gel-clot (limit test and semi-quantitative), kinetic turbidimetric (KTA), and kinetic chromogenic (KCA). Each method is validated for the specific sample matrix with inhibition/enhancement testing to confirm absence of interfering factors. We calculate maximum valid dilution (MVD) per pharmacopoeial requirements and provide endotoxin results referenced against USP <85>, IP, EP, and JP specifications.

Testing covers APIs, finished injectable products, WFI and purified water systems, medical device extracts, and raw materials. We also provide recombinant Factor C (rFC) testing as an animal-free alternative for clients with sustainability requirements.

BET Capabilities

  • Gel-clot LAL method — qualitative limit test per USP <85>
  • Kinetic turbidimetric assay (KTA) — quantitative endotoxin determination
  • Kinetic chromogenic assay (KCA) — quantitative endotoxin determination
  • Recombinant Factor C (rFC) assay — animal-free alternative
  • Inhibition/enhancement validation for complex sample matrices
  • Maximum valid dilution (MVD) calculation and verification
  • Water system endotoxin monitoring (WFI, PW, HPW)
  • Medical device extract endotoxin testing per ISO 10993-11

Turnaround Time

Standard BET: 3-5 business days
Rush BET: 1-2 business days
Method Validation: 5-7 business days
Water System Monitoring: 2-3 business days

Related Testing Services

Microbiological Testing Water System Validation NABL Accredited Lab All Pharma Testing →

Frequently Asked Questions — Bacterial Endotoxin Testing

What is bacterial endotoxin testing (BET)?
Bacterial endotoxin testing (BET) detects and quantifies endotoxins — lipopolysaccharides released from the cell walls of gram-negative bacteria — in pharmaceutical products, medical devices, and raw materials. Endotoxins can cause fever, septic shock, and organ failure in patients. The Limulus Amoebocyte Lysate (LAL) test is the standard method, using a reagent derived from horseshoe crab blood that clots in the presence of endotoxins. BET is mandatory for all parenteral drugs, ophthalmic preparations, and medical devices.
What LAL test methods does Auriga Research perform?
Auriga Research performs all three pharmacopoeial LAL methods: the gel-clot method (qualitative, limit test), the turbidimetric method (kinetic quantitative), and the chromogenic method (kinetic quantitative). We also offer recombinant Factor C (rFC) assays as an animal-free alternative. Method selection depends on the sample matrix, required sensitivity, and pharmacopoeial requirements.
What is the turnaround time for bacterial endotoxin testing?
Standard bacterial endotoxin testing at Auriga Research is completed within 3-5 business days from sample receipt. Rush testing is available within 1-2 business days for urgent release testing. Method validation and inhibition/enhancement testing require 5-7 business days.

Need Bacterial Endotoxin Testing for Your Products?

NABL-accredited LAL testing with 3-5 day turnaround. Gel-clot, turbidimetric, and chromogenic methods for regulatory compliance.

+91-7428116100 Get a Quote
Call Now Get a Quote

Type to search services, tests, and locations…