Regulatory-Compliant Bacterial Endotoxin Testing Solutions
Bacterial endotoxin testing (BET) is a critical quality control requirement for pharmaceutical products, biologics, medical devices, and parenteral preparations. Astor Scientific provides a comprehensive portfolio of Endotoxin Assays, Reagents, and Testing Consumables designed to support validated, compliant, and reproducible endotoxin detection in accordance with international regulatory standards.
Our solutions are manufactured under stringent quality control systems to ensure consistency, sensitivity, and traceability across all endotoxin testing workflows.
Product Portfolio
Gel-Clot LAL Assays
Qualitative and limit-based detection using Limulus Amebocyte Lysate (LAL), suitable for compendial compliance and routine QC release testing.
Chromogenic Endotoxin Assay Kits (Kinetic & Endpoint)
Quantitative endotoxin detection with high sensitivity and linear standard curves for validation and batch release.
Control Standard Endotoxin (CSE) & Endotoxin Challenge Vials (ECV)
Calibrated reference standards for assay validation, inhibition/enhancement testing, and method suitability studies.
Endotoxin-Free Water & Pyrogen-Free Consumables
Certified endotoxin-free reagents, vials, tubes, and tips to prevent contamination and ensure test integrity.
Automated Endotoxin Testing Systems
High-throughput platforms supporting GMP-compliant workflows and reduced operator variability.
Quality & Compliance
- Manufactured under controlled quality systems
- Lot-specific documentation and traceability
- Sensitivity calibrated to reference standards
- Designed for method validation and regulatory submission support
Astor Scientific — Reliable endotoxin testing solutions for regulated environments.