Sodium Ferric Gluconate: Product Description, Properties, and Uses

What is Sodium Ferric Gluconate?

Sodium ferric gluconate stands out as a water-soluble compound combining iron, gluconic acid, and sodium, showing up as a dark brown solid or a crystalline powder. Used across several industries, this material finds its most recognized role in healthcare for iron supplementation. Beyond that, its chemical structure brings stability and efficiency, which supports its application not only in pharmaceuticals but also in some technical formulations and analytical settings. The raw ingredient shapes up through complexation of ferric ions with gluconate, supplying a storied background of both scientific interest and commercial demand.

Physical and Chemical Characteristics

A closer look at sodium ferric gluconate offers valuable details. This substance takes the form of a brownish-black solid, which can also appear as fine powder, flakes, pearls, or as a stable liquid solution. Its molecular formula is C66H121FeO65Na, and its molecular weight lands at about 1871.15 g/mol. Density hovers around 1.47 g/cm³ for the solid form and varies across solubility contexts. Solubility in water runs high, enabling easy formulation of injectable and oral preparations. The melting point covers a wide range depending on crystalline water content, but the product has no pronounced odor and remains mostly inert in typical storage conditions.

Structure

Understanding the framework, the molecule intertwines ferric ions with gluconate ligands, bound together by sodium cations to balance the charge. Each ferric ion coordinates with the oxygen-rich gluconate, building a robust complex. This configuration maintains iron stability, keeping ferric ions in a bioavailable but non-reactive state. Lab work over the years has pointed out that this architecture limits free iron, which can be vital in controlling oxidative stress when the compound enters biological fluids.

Specifications and Standards

Manufacturers provide sodium ferric gluconate in various grades, with pharmaceutical and technical standards shaped by product application. The iron content usually sits between 5.7% and 8.0% by weight, with sodium gluconate as the counterion delivering both solubility and stability. Purity benchmarks control the presence of heavy metals, microbial contaminants, and free mineral acid. Solid forms arrive in both powder and flakes, supporting different preparation needs, while liquids come as concentrated solutions—measured in mg of iron per milliliter—to meet dosing precision for clinical or laboratory environments.

HS Code and Regulatory Information

For international shipment and customs purposes, sodium ferric gluconate falls under HS Code 29181600. Global regulations ask for clear product documentation, from certificates of analysis to material safety data sheets. This system preserves both traceability and safety, especially when dealing with bulk raw materials entering the supply chain for pharmaceutical manufacture or industrial research.

Safety and Hazardous Potential

Every user should approach sodium ferric gluconate with a good understanding of safety measures. While considered generally safe in controlled medical environments, the raw chemical can act as an irritant. Inhalation of fine dust may trigger respiratory discomfort, and direct eye or skin contact could cause mild irritation. The compound behaves as a mild oxidizer in some contexts—care in storage avoids accidental mixing with incompatible chemicals or reducing agents. Handling should occur with gloves, goggles, and appropriate ventilation, following standardized workplace safety procedures. Spill response plans matter, particularly for liquid solutions that can stain or leak iron residues.

Material Forms and Delivery

Distribution options for sodium ferric gluconate suit a variety of process needs. Solid forms—powder, flakes, granules—work well for accurate weighing and dissolution in batch production. Pearlized and crystalline versions allow for easier storage and extended shelf life. Liquid preparations—often in bottles or drums—help in high-volume pharmaceutical manufacturing, with concentration specified for dosing control. The product’s absorptive tendency means that packaging must seal tightly against moisture and air, safeguarding both purity and performance during extended storage.

Healthcare and Technical Uses

Today’s most familiar use of sodium ferric gluconate lands in intravenous iron therapies for patients with chronic kidney disease or anemia. Medical trials, published over decades, back up its safety and effectiveness for restoring iron levels without pushing the boundaries on allergic reactions compared to earlier iron salts. Still, healthcare providers monitor each infusion, aligning doses with lab data and individual risk factors. Beyond the clinic, technical applications include analytical chemistry and as an intermediate in reagent streams, thanks to robust chelation properties and manageable reactivity.

Raw Material Sourcing and Sustainability

Sourcing sodium ferric gluconate starts with high-purity iron salts and gluconic acid derived from glucose fermentation. Responsible suppliers run their operations with traceability and sustainability in mind. Throughout the last decade, the industry has moved forward by eliminating hazardous by-products and shifting to greener solvent systems, which reduces the environmental footprint. As demand continues, both manufacturers and end-users can look for supply partners that deliver transparency and demonstrate engagement with global sustainability initiatives.

Possible Challenges and Approaches

A critical challenge for sodium ferric gluconate involves maintaining both quality and affordability as demand rises in the global market. Supply interruptions can threaten patient care and industrial research. To tackle these, companies double down on supply chain management, contract multiple raw material sources, and invest in robust testing methods. The risk of contamination or mislabelling remains, so ongoing staff training, good documentation, and investment in analytical equipment like HPLC or ICP-MS help reinforce quality control. In research, new delivery systems and advanced formulations could stretch the benefits of sodium ferric gluconate to broader clinical settings and improve efficacy for patients with severe iron deficits.

Storage, Disposal, and Environmental Concerns

Safe storage of sodium ferric gluconate requires cool, dry, well-ventilated areas, keeping containers tightly sealed to guard against moisture uptake and oxidative breakdown. Liquid forms store best in amber glass or HDPE drums that block light and prevent chemical interaction. Expired or unused product must reach a certified chemical waste processor, avoiding direct disposal to drains or landfill. Regular audits, supported by global best practice guidelines, help cut down on environmental harm and protect water systems from excess iron and complexing agents.

Final Thoughts on Value and Importance

In the world of specialty chemicals and modern healthcare, sodium ferric gluconate claims a role that blends chemical stability, safety, and clinical value. The physical and molecular attributes serve ambitious research, fast-moving hospitals, and skilled manufacturers, each tapping into the qualities that have set this iron compound apart for decades. Future-facing approaches—grounded in transparency, smart sourcing, and a commitment to sustainable chemistry—promise to keep sodium ferric gluconate at the forefront of safe iron delivery and versatile industrial use.