Edetate Calcium Disodium BP EP USP Pharma Grade: Properties, Structure, and Comprehensive Insights

What is Edetate Calcium Disodium BP EP USP Pharma Grade?

Edetate Calcium Disodium, recognized across pharmaceutical and chemistry sectors, has evolved into a staple raw material thanks to its effectiveness in chelation and detoxification processes. With multiple references under BP, EP, and USP standards, its application extends over pharmaceutical, industrial, and laboratory use. People often encounter this white to off-white solid in powder, flakes, pearls, or crystalline forms. The compound belongs to the class of aminopolycarboxylic acids, serving as a chelating agent that binds with heavy metals, making those toxic ions easier to remove from biological or chemical systems. A look at the raw material and purity standards of BP, EP, and USP lets users rely on its consistent quality and precise specification.

Chemical Properties and Structure

The molecular structure of Edetate Calcium Disodium displays its designed dual affinity for metal ions. Its chemical formula, C10H12CaN2Na2O8·xH2O, merges the chelating backbone of ethylenediaminetetraacetic acid (EDTA) with calcium and sodium ions. The calcium ion offers selectivity, maintaining sodium ions as counter ions and giving the whole molecular entity increased solubility without risk of picking up essential calcium from biochemistry systems. Molecular weight lands near 410-450 g/mol, accounting for variations in hydration. As a solid, specific gravity typically stands around 0.86 to 0.90, with water solubility allowing for rapid dissolution. It stands stable at room temperature, but direct contact with strong oxidizing agents or acids triggers decomposition, introducing toxic emissions you don't want in any lab or production environment.

Physical Appearance and Specifications

Manufacturers supply Edetate Calcium Disodium as free-flowing white powder, compact pearls, chunky flakes, or crystalline solid, always prioritizing absence of odor and even particulate size distribution for effective handling. Whether it’s packaged in drums or bags, each batch must clear strict testing for purity (over 99% by assay), insoluble matter, pH (ranging approximately 6.5 to 8.0 in a 5% aqueous solution), and identifiable markers like calcium and sodium content. There’s a real focus on avoiding impurities—heavy metals shouldn’t exceed 10 ppm for pharma-grade lots, and microbial limits remain tough to meet. Water insoluble matter gets checked down to fractions of a percent, preventing any risk for pharma and injectable uses. Powder dissolves in water but practically insoluble in organic solvents, driving its utility for intravenous and oral pharmaceutical preparations.

HS Code and Regulatory Considerations

Trade and importers classify Edetate Calcium Disodium using the HS Code 29224985 under chemical and pharmaceutical product categories. This code forms the backbone for regulatory declarations and international transport. Industry specialists know to check for compliance with REACH, FDA, and equivalent regional chemical safety notifications when sourcing. Sites handling this substance require Material Safety Data Sheets on deck since labelling, shipping documentation, and occupational exposure limits strictly apply. For pharma, manufacturing under cGMP delivers traceability from raw material sourcing through finished final use.

Density and Solution Behavior

Solid density tends to range between 0.80 and 0.90 g/cm³, a factor influencing how it packs and ships in bulk. Blending the powder with water generates clear colorless solutions if the dose and dissolution technique get managed carefully. In production-scale laboratories, users prepare stock solutions, often at 100 g/L or 200 g/L concentrations, suitable for further formulation. In the presence of extracorporeal metals, chelation proceeds rapidly—solution stability depends on storage away from heat, direct sunlight, and metal contaminants. During handling, avoiding dust inhalation and preventing eye or skin exposure becomes vital since fine powder can cause mild irritation to sensitive individuals.

Safe Handling, Hazardous Characteristics, and Recommendations

Users treat Edetate Calcium Disodium as a chemical with moderate hazards—not acutely toxic, but chronically damaging at high exposure or misuse. The powder can dry skin and trigger allergic responses for sensitive operators, so standard operating protocols insist on gloves, eye protection, and well-ventilated environments. Chemical compatibility lists suggest blocking direct mix with strong oxidizers and reducing agents. Accidental releases clean up with copious water or inert absorbent; disposal follows local hazardous waste regimes. For pharmacy and compounding specialists, precise dosing matters: overdoses in chelation therapy can interfere with electrolyte balance, especially by skewing essential metal ion availability if given in error. Regulatory authorities demand risk/benefit profiling before any new injectable product rollout, setting a high standard of pharmaco-vigilance.

Importance as a Raw Material

Being a backbone raw material, Edetate Calcium Disodium finds daily use in therapeutic applications for metal poisoning, from children with lead exposure to industrial workers recovering from toxic element contact. Its low cost of ownership, ease of storage, well-understood stability, and clear specifications let companies build effective chelation therapies and diagnostic solutions without swerving from internationally accepted benchmarks. On the manufacturing floor, tracking batch numbers and shelf life means avoiding contamination, and every bulk order usually includes retesting for quality and compliance. Hospitals, compounding pharmacies, and OEM pharma labs all depend on this raw material’s consistent quality to guarantee patient safety and reliable performance.

Reputable Sourcing and Future Trends

My time in regulated chemical distribution has shown the importance of sourcing from pharmaceutical GMP-certified plants where trace metals and microbiological purity surpass baseline standards. Adulteration or substitution, even at low levels, can dismantle a supply chain or cause real harm. Technology continues refining purity detection and contamination avoidance. With a global push for sustainable and eco-friendly chemical processes, suppliers look for greener EDTA production methods to drop the environmental load associated with chelating agents. For those in procurement or development roles, working with partners who invest in analytics and transparent lot documentation pays off in fewer recalls and longer business relationships.