Nicotinic Acid BP EP USP Pharma Grade: Description, Properties, Structure, and Key Details

Product Overview

Nicotinic acid, also recognized throughout science circles as niacin or vitamin B₃, delivers a critical raw material for pharmaceutical, chemical, and nutritional industries. This solid, white, crystalline powder carries an understated but impactful presence among chemical compounds vital to human health. Its pharmaceutical grade follows rigorous British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP) standards. Each batch must match exact physical and purity criteria, aligning with the expectations in medicine and manufacturing.

Chemical Structure and Molecular Properties

A look at its atomic breakdown reveals the formula C₆H₅NO₂, representing a pyridine ring core fused with a carboxyl group in the beta position. This structure shapes not only its chemical possibilities but every practical application in food fortification, dietary supplements, and pharmaceutical preparations. Nicotinic acid marks a molecular weight of 123.11 g/mol. Solubility stands medium in water, higher in hot water, with limited movement in alcohol. These behaviors carry weight in production settings, deciding process efficiencies and equipment needed.

Physical Appearance and Specifications

Most suppliers present this material as fine, white crystalline powder. The texture sometimes takes the form of small pearls or flakes, reflecting variability by manufacturer and crystallization technique. Melting point centers around 236°C to 239°C. The density approximates 1.473 g/cm³, important for warehouse stacking, blending in formulations, or dissolving in solvents. Scent remains mild and slightly acidic, not aggressive, distinguishing it from related compounds. Clarity becomes obvious under a microscope – sharp-edged particles, clean transparency, and no visual contamination when produced at pharma grade. Specific rotation equals zero since the crystalline form does not bend light, an expected trait given its simple structure.

HS Code and International Classification

Regulators and customs agents track nicotinic acid under HS Code 2936.26. This number follows it worldwide, connecting customs clearance, documentation, and global trade. Assignments under this code ease logistics, compliance checks, and inventory controls. The harmonized system enables chemical companies and exporters to align with product classification in nearly every market, avoiding costly mix-ups at ports or with tax authorities.

Material Properties: Solid, Flakes, Powder, Pearls, or Crystal

Nicotinic acid shows up most often as a solid, specifically as powder or crystalline granules. Some specialty producers sell larger flakes or nuggets, enabling alternate dosing and mixing strategies for supplement manufacturers. Rarely, it appears as dense pearls, usually under laboratory or research orders, demanding high-purity attributes. In all cases, the physical state matches the needs of mass blending, tablet pressing, and encapsulation. Liquid solutions arise from dissolving the powder in precise solvent volumes, supporting custom applications in analytical chemistry and medical diagnostics.

Safe Handling, Hazards, and Chemical Risks

Workplaces dealing with nicotinic acid must approach it with practical respect. Inhalation of fine particles may irritate airways or trigger short-term discomfort for workers. Direct contact with eyes calls for immediate rinsing, as any chemical dust causes temporary pain. Ingesting high quantities outside regulated doses risks harmful effects, though toxicosis remains low compared to concentrated industrial chemicals. Safety data sheets flag the compound as an irritant, not a corrosive or carcinogen by global standards. For bulk storage, companies rely on dry, well-sealed environments, keeping the crystalline form dry and out of sunlight or excessive heat. This protects both the quality and safety of the product for workers and end-users.

Key Pharmaceutical Applications

From everyday vitamin supplements to injectable solutions, this molecule continues to hold its ground. Nicotinic acid works at its core as an essential human nutrient, needed for tissue repair, DNA synthesis, and energy systems. Pharmaceutical industries source pharma grade stocks for tablet manufacturing, slow-release capsules, and dietary powders. Hospitals leverage it for treating severe deficiency syndromes, like pellagra, especially in undernourished patient populations. Formulators blend it with excipients, binders, and fillers, building dosage forms meeting diverse patient health needs. The consistency of the crystalline material ensures uniformity in every dose, a non-negotiable requirement in modern medical care.

Quality Control and Regulatory Compliance

Lab batches undergo strict purity and identity testing per BP, EP, and USP requirements. Every kilogram comes with certificates of analysis – demonstrating assays above 99% purity, minimal moisture, and freedom from unwanted metals or residual solvents. These checks reflect the trust placed in nicotinic acid, especially among pharmaceutical and dietary supplement makers. New guidelines, updated by regulators every few years, prompt manufacturers to modernize practices, push for cleaner production, and erase batch variability. Each lot needs traceability to raw material sourcing and processing steps, supporting recalls and audits if needed. With worldwide trade on the rise, harmonizing with new regulatory standards becomes a daily challenge for companies, pressing the need for technical documentation and international laboratory validation.

Environmental and Social Considerations

The background work of chemical production has grown more transparent. Energy inputs, solvent recovery, and water treatment move to the forefront as companies sound alarms about climate and waste. Workers need protective gear and clear safety instructions, stepping away from decades-old practices where dust clouds filled unventilated rooms. Health experts voice concerns about cross-contamination, so companies dedicate separate lines for pharma grade stocks, away from technical or feed grades loaded with trace metals. Addressing community questions about plant emissions, packaging waste, and long-haul shipments answers not only customer demands for non-hazardous handling but shareholders who recognize the role of environmental, social, and governance (ESG) reporting in long-term value.

Potential Improvements and Future Directions

Looking ahead, shifting diet trends and regulatory moves will shape how nicotinic acid gets sourced, refined, and distributed. Green chemistry techniques—reducing solvent use and investing in next-generation purification—set the tone for lower emissions and higher yield. Automation and closed-system production reduce worker exposure, which cuts down on risk across packaging, storage, and distribution pipelines. Increasing demand for traceable, sustainable supply means firms invest in digital tracking, QR-coded documentation, and third-party audits. Streamlining regulations across BP, EP, and USP booklets may someday erase regional barriers, boosting universal access in both medicine and basic nutrition. As countries face malnutrition or shift toward preventive health, demand for safe, tested, and reliable vitamin compounds only rises, calling on everyone in the industry to keep quality, safety, and supply chain transparency front and center.