Sodium Stearyl Fumarate BP EP USP Pharma Grade: Properties, Structure, and Material Insights

What is Sodium Stearyl Fumarate?

Sodium Stearyl Fumarate, known under the monographs BP, EP, USP Pharma Grade, appears as a versatile excipient. Its presence shines in the pharmaceutical sector, where reliable tablet manufacturing needs dependable lubricants and disintegrants. With a chemical formula of C22H41NaO4 and a molecular weight of approximately 392.54 g/mol, Sodium Stearyl Fumarate serves as more than a technical additive. The market recognizes it by HS Code 29171980, marking its place among ester-based surfactants.

Physical and Chemical Properties

Physically, Sodium Stearyl Fumarate sits somewhere between a firm solid and a soft powder, with commercial forms offering versatility: dense flakes, fine powder, or pearled granules. Its solid form often appears white or off-white, maintaining a neutral odor profile—no harsh or pungent scent, making handling easier in clean-room conditions. Its solid-state supports a melting point in the range of 110 to 120°C, providing heat stability during many standard pharmaceutical processes. Density ranges between 0.25 and 0.35 g/cm³ for loose powder, and the compressed bulk format increases this value slightly, reflecting its adaptability for tablet mechanisms.

Sodium Stearyl Fumarate remains practically insoluble in water, resisting easy dissolution, but its hydrophobic backbone gives it a gentle dispersibility when mixed with compatible excipients. This property explains why manufacturers lean on it for moisture-sensitive formulas. Direct compression techniques benefit from its ability to avoid sticking or clumping, which often plague less robust lubricants and flow agents. Chemically, the structure features a stearyl group attached to a fumaric acid backbone, with sodium atoms contributing to its salt nature. The fumarate portion includes a double bond, giving the molecule rigidity and thermal resilience. Stearyl chains, on the other hand, balance out with flexible, hydrophobic tails, further contributing to its role in tablet formation.

Safety, Hazard, and Handling Factors

In terms of safety, Sodium Stearyl Fumarate gets solid marks for low toxicity, but all chemical material needs careful storage and use. GHS classification presents it as a non-hazardous substance under routine pharmaceutical operations. Eye or respiratory irritation rarely shows up in data, provided dust control remains tight. Inhalation of powder in large amounts could cause minor discomfort, similar to talc or other inert excipients. The product carries no significant reactivity risk with most standard raw materials, aside from strong acids, which can degrade it into stearic and fumaric acids, plus sodium salts.

Application and Raw Materials

Practical use relies not only on purity but consistency in bulk structure. Leading pharma producers prefer raw materials with defined particle profiles, ensuring each batch behaves like the next—important for the regulated world of drug manufacture. Sodium Stearyl Fumarate works as both a lubricant and a flow agent, limiting tablet sticking in presses, and supporting even, predictable disintegration in the digestive tract. Shelf stability, lack of odor, and resistance to absorption of water support its use in formulations where controlling moisture is critical.

Material Quality and Industry Standards

According to BP, EP, and USP standards, only Sodium Stearyl Fumarate batches meeting strict assay and impurity limits qualify for pharma label usage. Moisture, peroxide value, and identification tests follow strict protocols. Manufacturers verify the presence and structure using IR spectroscopy, ensuring no contamination from other fatty acid derivatives. Achieving pharmacopeial listing depends on traceability and batch-to-batch reproducibility, critical for large-volume OTC and prescription tablet lines.

Environmental and Regulatory Considerations

On the environmental front, this material presents low-impact risk under typical industrial use, with waste channels designed to handle mineral-based salt products. Disposal procedures avoid acid-neutralization where possible, limiting exothermic reactions. Factory policy often focuses on dust collection and employee training in safe material transfer—preventing workplace exposure becomes a routine, not an afterthought. Sodium Stearyl Fumarate avoids the more serious health and flammability risks found with solvents and volatile surfactants, reflecting regulatory approval in both Europe and the United States.

Conclusion: A Reliable Pharmaceutical Raw Material

Sodium Stearyl Fumarate, with a solid chemistry background and reliable bulk properties, delivers stability and process efficiency where it counts. Solid, powder, or pearled forms each tailor to the next step at the tablet press. From controlled structure to established safety, it meets the demands of pharmaceutical quality and regulatory oversight. Its continued use portrays the ongoing balance between formulation science and product safety—a mark of good manufacturing and a result of continued chemical refinement.