Description

Endotoxin CAS NO 67924-63-4 is a complex lipopolysaccharide (LPS) derived from the outer membrane of Gram-negative bacteria, widely recognized as a critical standard and reagent in biomedical research and quality control. Its primary value lies in its use for the validation, calibration, and quality testing of systems designed to detect bacterial endotoxins, which are potent pyrogens. This product is essential for industries and laboratories focused on sterility assurance, including pharmaceutical manufacturing, medical device production, and in vitro diagnostic development, where controlling pyrogenic contamination is paramount.

Application

• Limulus Amebocyte Lysate (LAL) Test Validation: Used as a reference standard to validate the sensitivity and accuracy of LAL reagent tests for bacterial endotoxin detection.
• Pharmaceutical Quality Control: Critical for testing parenteral drugs, vaccines, and injectable solutions to ensure they are free from pyrogenic contaminants.
• Medical Device Testing: Employed in the pyrogen testing of implants, surgical instruments, and dialysis equipment to meet regulatory safety standards.
• Research & Development: Serves as a key reagent in immunological studies, sepsis research, and the development of endotoxin detection assays and neutralizing agents.
• In Vitro Diagnostic (IVD) Manufacturing: Used in the production and calibration of diagnostic kits designed to detect endotoxemia or Gram-negative bacterial infections.
• Laboratory Proficiency Testing: Acts as a known challenge material in inter-laboratory comparisons and quality assurance programs for microbiology labs.

Basic Information

Product Name	Endotoxin
CAS No.	67924-63-4
Molecular Formula	Variable polymeric structure
Molecular Weight	High molecular weight polymer (typically 10-20 kDa)
Synonyms	Bacterial Endotoxin; Lipopolysaccharide (LPS); Pyrogen; Gram-negative Bacterial Endotoxin; LPS Standard; Endotoxin Standard; B.E.S.; E. coli Endotoxin (common source); Klebsiella Endotoxin; Salmonella Endotoxin
EINECS	Contact for details

Quality Control

Our endotoxin standards are produced and controlled under a strict quality management system to ensure batch-to-batch consistency and traceability. Each lot is rigorously tested for potency (Endotoxin Units per vial) and validated against relevant pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided, detailing the assigned potency, purity, and results of identity and sterility tests. We support compliance with USP <85>, EP 2.6.14, and JP 4.01 bacterial endotoxins test chapters.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C. This product is hygroscopic (moisture-sensitive). For long-term stability, it is recommended to store desiccated. Avoid repeated freeze-thaw cycles of prepared solutions.

Specification

Item	Specification
Appearance	White to off-white powder or solid
Identification (IR)	Conforms to reference standard
Potency (Endotoxin Units/vial)	As stated on label (e.g., 10,000 EU/vial)
Purity (HPLC)	≥ 95% (by area normalization)
pH (Solution)	6.0 - 8.0 (1 mg/mL in water)
Loss on Drying	≤ 5.0 %
Bacterial Endotoxins (LAL)	Potency confirmed per USP/EP
Sterility (Membrane Filtration)	Sterile

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.