Description

Endotoxin CAS NO 11034-88-1 is a complex lipopolysaccharide (LPS) component derived from the outer membrane of Gram-negative bacteria. It is a critical standard and reagent used in the pharmaceutical and medical device industries for pyrogen and bacterial endotoxin testing. This product is essential for quality control laboratories, research institutions, and manufacturers requiring reliable reference materials to ensure product safety and compliance with stringent pharmacopeial standards.

Application

• Limulus Amebocyte Lysate (LAL) Testing: Used as a reference standard in gel-clot, turbidimetric, and chromogenic LAL assays to detect and quantify bacterial endotoxins in parenteral drugs, vaccines, and medical devices.
• Pharmaceutical Quality Control: Serves as a positive control and calibration standard for in-process and final product testing to meet USP <85>, EP 2.6.14, and JP 4.01 requirements.
• Medical Device Validation: Critical for validating the endotoxin testing process for implants, dialysis equipment, and other sterile medical products.
• Research and Development: Utilized in immunological studies, sepsis research, and the development of novel endotoxin detection methods and neutralizing agents.
• Biologics and Vaccine Production: Employed to monitor raw materials, cell cultures, and purification processes for endotoxin contamination.
• Water for Injection (WFI) Systems: Used to test and validate the endotoxin-free status of WFI and pure steam systems in manufacturing facilities.

Basic Information

Product Name	Endotoxin
CAS No.	11034-88-1
Molecular Formula	Variable (Lipopolysaccharide Complex)
Molecular Weight	Variable (Typically 10-20 kDa)
Synonyms	Bacterial Endotoxin; Lipopolysaccharide; LPS; Pyrogen; Gram-negative Endotoxin; EC Endotoxin; BET Standard; USP Endotoxin Reference Standard; RSE (Reference Standard Endotoxin); CSE (Control Standard Endotoxin)
EINECS	Contact for details

Quality Control

Our Endotoxin is manufactured and tested under strict quality systems to ensure consistency and traceability. Each batch is calibrated against an internationally recognized reference standard (e.g., USP RS or WHO IS) to define its potency in Endotoxin Units (EU). A comprehensive Certificate of Analysis (COA) is provided, detailing the potency, purity, and suitability for use in LAL testing methods compliant with USP, EP, and JP monographs.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C. This material is hygroscopic (moisture-sensitive). Allow the vial to equilibrate to room temperature in a desiccator before use to prevent condensation. For long-term stability, store desiccated.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or cake
Identification (IR)	Conforms to structure
Potency (Labeled)	XX,XXX EU/vial (Batch Specific)
Purity (Protein Content)	< 1% (w/w)
Nucleic Acid Content	< 1% (w/w)
Reactivity (LAL Test)	Fully reactive in gel-clot and kinetic assays
pH (in solution)	6.0 - 8.0
Bacterial Endotoxins	N/A (This is the analyte)
Water Content (K.F.)	< 5.0%

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