Disodium Edetate for Injection BP EP USP Pharma Grade: Description and Physical Profile

What is Disodium Edetate?

Disodium Edetate, recognized under BP, EP, and USP quality standards, comes through as a chelating agent working directly with calcium, magnesium, and other metal ions. This substance often sits on pharmaceutical manufacturers’ shelves, standing as a key ingredient for formulating injectable drugs. Its structure offers stable sequestration of divalent and trivalent metal ions, helping control metal-catalyzed reactions during production and ensuring the substance preserves sensitive active ingredients.

Physical Properties and Structure

Physical characteristics draw a clear line around this chemical’s practical uses. Disodium Edetate presents as a white, odorless solid, showing itself as a powder, crystalline flakes, or compact pearls. One of the more noticeable features is its density—sitting around 0.86–0.95 g/cm³ as a powder—making it easy to handle in bulk for compounding or mixing operations. Disodium Edetate's high solubility in water simplifies both storage and preparation for solutions used in injection manufacturing. In its solid forms, ranging from fine powders to larger flakes or pearls, the material resists caking and maintains flow, even in high-humidity conditions.

Chemical Specifications and Formula Details

The molecular formula of Disodium Edetate is C10H14N2Na2O8·2H2O, with a molecular mass sitting at 372.24 g/mol. Each molecule carries two sodium ions bonded to an EDTA backbone, maximizing its capacity to chelate metals. It follows strict purity benchmarks set by BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia), often with heavy metal content below 10 ppm and a defined pH for 5% solution in the 4.0 to 5.5 range. Pharmaceutical specifications usually target the elimination of hazardous contaminants, so routine heavy-metal, arsenic, and nitrate testing become part of the quality assurance checklist. The HS Code for this raw material falls under 29212100, referencing acyclic polyamino compounds used in large-scale pharmaceutical synthesis.

Forms and Handling: Flakes, Powder, Pearls, Liquid, and Crystal

Depending on production processes, Disodium Edetate shows up as crystalline flakes, micro-fine powder, lentil-shaped pearls, clear solutions, or pristine crystals. Flakes and powder forms handle bulk processing schedules with ease, offering fast dilution and consistent measurement for batch compounding. Pearls exhibit low dusting, which operators value when pouring from large drums. As a liquid, Disodium Edetate concentrates allow for direct addition to injectable them with zero loss from undissolved content. Crystals stay free-flowing, resisting compaction, which proves valuable for storage and repeated sampling.

Density, pH, and Safety Considerations

Bulk density typically lands between 0.86 and 0.95 g/cm³, with true density around 1.01-1.04 g/cm³, as measured by density meters. A standard solution at 5% w/v registers a pH of about 4.5 to 5.0 at room temperature. Material safety data classifies Disodium Edetate as low-hazard, but direct inhalation of powder, ingestion in amounts above therapeutic thresholds, or contact with eyes or skin can cause local irritation. No persistent bioaccumulation is recorded, with most biological systems removing excess through the urine. In laboratory or production environments, personnel depend on gloves, safety glasses, and dust masks, especially with fine powder variants. All forms must stay dry, sealed, and away from incompatible chemicals like strong acids, oxidizers, or calcium-rich raw materials.

Hazardous and Harmful Properties

Though classified as low-toxicity, this chemical carries concerns about its cumulative metal-binding activity. Excessive exposure disrupts internal balance of calcium, leading to hypocalcemia if overdosed. No significant explosion or flammability hazard exists, though fine particles in closed environments risk minor respiratory irritation. Most shipping containers receive standard hazardous labeling under GHS as a minor irritant—careful training guides operators through cleaning accidental spills with minimal water, capturing all residue for managed waste streams.

Role as a Raw Material in Pharmaceutical Manufacturing

Production lines for injectable pharmaceuticals rely on Disodium Edetate as a stabilizer against metal-catalyzed oxidation, especially with antibiotics, biologics, or hormone injections. Purity lines up directly with pharmaceutical industry standards: BP, EP, and USP grades restrict trace impurities and guarantee rapid dissolution in solution. Raw powders or pearls come pre-tested for microbial content and metal concentrations, helping to build trust in injectable safety and efficacy. Chemists and engineers engage with each specification, from apparent bulk density to granulometry, as routine parameters during raw material intake.

Industry Perspective and Paths Toward Safer Use

Pharmaceutical operators—pharmacists, chemists, environmental safety officers—see Disodium Edetate as vital for managing quality and stability in sterile injectable products. Industry improvements focus on tighter particle-size control to minimize dust formation, improved packaging to preserve flow properties, and robust training for storage and handling. Suppliers track traceability for each drum, batch, and lot to ensure compliance with global pharmacopoeia standards. In large-scale production, carefully calibrated dosers and closed-system mixing tanks prevent operator exposure. Disposal routes stay tightly regulated, ensuring no bioavailable chelant flows into soil or water streams after manufacturing ends. Compliance teams run regular audits to keep safety and environmental standards in check. These efforts strengthen confidence among regulators, users, and the wider healthcare community who rely on safe injectable medicine.