Disodium edetate dihydrate

Product Data

Disodium EDTA 2-hydrate (CAS No. 6381-92-6) is a high-purity chelating agent manufactured by Dr. Paul Lohmann^®. Known for its stability, effectiveness, and versatility, it plays a crucial role in biopharmaceutical and pharmaceutical formulations as a stabilizer and complexing agent.

General Characteristics

Synonyms: EDTA Disodium Salt Dihydrate, Ethylenediaminetetraacetic acid disodium salt dihydrate, Edetate disodium salt dihydrate

Formula	C₁₀H₁₄N₂Na₂O₈ * 2H₂O
Molecular weight	372.24 g/mol
CAS No.:	6381-92-6
EINECS No.:	205-358-3
HS No.:	29224985

Product number	Product parameter	Storage conditions \| Retest period	Additional information
505062001	crystalline powder Ph.Eur.11.Ed. \| USP-NF 2025 \| Low in Endotoxins \| JP 17, JP 17, e Solubility 20 °C: ++ \|	; 24 months

++ > 100 g/l | + 10 - 100 g/l | − 1 - 10 g/l | −− < 1 g/l
The solubility specified here was measured in water. The solubility is influenced by many factors in the application.

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Benefits of Disodium EDTA 2-hydrate (CAS No. 6381-92-6)

With decades of expertise in producing high-quality mineral salts and functional ingredients, Dr. Paul Lohmann^® offers Disodium EDTA 2-hydrate with:

Outstanding Purity: Produced under strict quality control to meet pharmaceutical-grade specifications and ensure safety in sensitive applications.
Excellent Stability: Chemically and thermally stable, ensuring consistent performance across a wide pH range and under various formulation conditions.
Customizable Specifications: Tailored to meet specific regulatory, functional, or processing requirements in biopharmaceutical and pharmaceutical manufacturing.

Certifications and Quality Standards

We maintain the highest standards of quality management to ensure consistent, compliant, and reliable products. Our Disodium EDTA 2-hydrate meets international regulatory expectations for use in pharmaceutical and biopharmaceutical processes.
Key Certifications:

GMP Compliance
ISO 9001 Quality Management
FSSC 22000 Food Safety
REACH Registration

Applications of Disodium Edetate Dihydrate (CAS No. 6381-92-6)

Biopharmaceutical Applications

Our Disodium EDTA 2- hydrate, low in endotoxins and RNase, has various functions inside biopharmaceutical processing:

Preservative and Stabilizer: EDTA acts as a preservative by chelating metal ions that may otherwise catalyze the oxidation or degradation of desired products in biopharmaceutical formulations. This helps you extending the shelf life of your biopharmaceutical products.
Metal Ion Control: Biopharmaceutical processes involve metal-dependent enzymes or reactions. Disodium EDTA can be used to control the concentration of metal ions in these processes.
Buffering Agent: It serves as a buffer, regulating solution pH to maintain the desired pH range, thus ensuring the stability and efficacy of the biopharmaceutical product.

Pharmaceutical Applications

In pharmaceutical formulations, Disodium EDTA 2-hydrate is widely used to stabilize active ingredients and improve product shelf life. It binds metal ions that could otherwise catalyze oxidation or discoloration, ensuring formulation integrity.
Key applications include:

Injectable and ophthalmic preparations: Maintains clarity, prevents oxidation, and enhances preservative efficacy.
Topical and oral formulations: Improves stability of active ingredients in creams, gels, and liquid preparations.
Antibiotic and vitamin formulations: Prevents degradation of sensitive compounds and ensures consistent potency.

Why Choose Dr. Paul Lohmann^® for Disodium EDTA 2-hydrate?

As a global leader in Mineral Salts and specialty excipients, Dr. Paul Lohmann^® is dedicated to providing high-performance, pharma-grade ingredients. Our Disodium EDTA 2-hydrate is produced using advanced manufacturing technologies, strict GMP controls, and decades of expertise – ensuring maximum purity, stability, and regulatory compliance.
Looking for a trusted partner for Disodium EDTA 2-hydrate (CAS No. 6381-92-6) in your biopharmaceutical or pharmaceutical applications?
Contact us today for customized specifications, technical documentation, and tailored solutions to meet your process and formulation needs.

Frequently asked questions about this product

What is Disodium EDTA 2-hydrate?

Disodium EDTA 2-hydrate is the disodium salt of ethylenediaminetetraacetic acid (EDTA) in its hydrated form. It functions as a powerful chelating agent, binding metal ions to enhance the stability and shelf life of formulations.

In which applications is Disodium Edetate Dihydrate used?

The product is primarily used in biopharmaceutical and pharmaceutical applications to stabilize sensitive actives such as proteins, enzymes, or peptides. It is also utilized in cell culture media, injectable solutions, ophthalmic formulations, topical preparations, and antibiotic products.

How does Disodium EDTA 2-hydrate work in pharmaceutical formulations?

It binds metal ions such as iron, copper, or calcium that can catalyze oxidative degradation. By forming chelates, it protects active ingredients from breakdown, enhances formulation stability, and improves the performance of preservatives.

What are the benefits of Disodium Edetate Dihydrate in biopharmaceutical processes?

In biopharmaceutical processes, it helps stabilize proteins and cell cultures, controls metal ion concentrations, and prevents unwanted reactions during fermentation, purification, and formulation. This enhances product quality and overall yield.

Is Disodium EDTA 2-hydrate suitable for use in GMP-regulated environments?

Yes. Dr. Paul Lohmann^® manufactures Disodium EDTA 2-hydrate in compliance with GMP, ISO 9001, and FSSC 22000 standards, ensuring suitability for regulated pharmaceutical and biopharmaceutical use.

What are the physical properties of Disodium EDTA 2-hydrate?

It is a white, crystalline powder that is soluble in water. It exhibits high chemical stability and is effective across a wide pH range.

How is the Disodium Edetate Dihydrate packaged and stored?

Disodium Edetate Dihydrate is supplied in moisture-proof containers. It should be stored in a cool, dry, and tightly closed environment to maintain product quality.

The information given on this Website corresponds to our current knowledge. We warrant in the frame of our General Terms and Conditions of Sale that our products are manufactured in accordance with the specifications. However, we disclaim any liability with regard to the suitability of our products for a particular purpose or application or their compatibility with other substances. Tests have to be performed by the customer who also bears the risk in this respect. Nothing herein shall be construed as a recommendation to use our products in conflict with third parties' rights.