Description

Diphtheria Toxin is a potent exotoxin produced by *Corynebacterium diphtheriae*, a key biological reagent in biomedical research and vaccine development. Its primary commercial value lies in its critical role as a reference standard for potency testing of diphtheria toxoid vaccines, ensuring global immunization safety and efficacy. This product is essential for pharmaceutical manufacturers, contract research organizations (CROs), and diagnostic kit developers working in immunology, toxicology, and infectious disease research.

Application

• Vaccine Potency Testing: Serves as the primary reference standard for the in vivo and in vitro potency assays of diphtheria toxoid vaccines, a mandatory requirement for batch release.
• Immunological Research: Used as a model antigen to study immune response mechanisms, antibody neutralization, and T-cell activation.
• Toxicity & Mechanism Studies: Employed in cellular and molecular biology research to investigate ADP-ribosylation, protein synthesis inhibition, and apoptotic pathways.
• Diagnostic Development: Acts as a critical component in the development and calibration of immunoassays and diagnostic tests for diphtheria immunity.
• Antitoxin Standardization: Used to standardize and calibrate diphtheria antitoxins for therapeutic use and quality control.
• Biodefense & Biosafety Research: Studied as a select agent model for developing countermeasures and understanding bacterial pathogenesis.

Basic Information

Product Name	Diphtheria Toxin
CAS No.	92092-36-9
Molecular Formula	Contact for details
Molecular Weight	Approx. 58 kDa (monomer)
Synonyms	Diphtheria Toxin; DT; DTx; Corynebacterium diphtheriae toxin; Diphtheric toxin; Diphtheria exotoxin; CRM197 (cross-reacting material, non-toxic mutant); Diphtheria toxin fragment A; Diphtheria toxin fragment B
EINECS	Contact for details

Quality Control

Our Diphtheria Toxin is produced and handled under stringent quality systems suitable for research and diagnostic applications. Each lot is characterized for identity, purity, and biological activity. Certificates of Analysis (COA) are provided, detailing specifications such as protein concentration, purity by SDS-PAGE, and specific activity in a Vero cell cytotoxicity assay. While not intended for direct human therapeutic use, our quality protocols align with the rigorous standards expected for critical biological reagents.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store frozen at -20°C to -70°C. Avoid repeated freeze-thaw cycles. This material is hygroscopic (moisture-sensitive); allow the vial to equilibrate to room temperature in a desiccator before opening to prevent condensation. Handle in accordance with biosafety level 2 (BSL-2) practices.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear solution
Identification (Immunodiffusion)	Positive reaction with specific antitoxin
Protein Content (UV Absorbance)	≥ 90%
Purity (SDS-PAGE)	Single major band, ≥ 95%
Specific Activity (Vero Cell Assay)	Defined CD50/mg (Contact for details)
Endotoxin (LAL)	< 10 EU/mg
Sterility (Membrane Filtration)	Sterile

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