L-Phenylephrine Bitartrate: Properties, Structure, and Chemical Significance

What is L-Phenylephrine Bitartrate?

L-Phenylephrine bitartrate stands out as a well-known compound in both the pharmaceutical and chemical industries. This substance serves as a raw material for a range of pharmaceutical formulations and holds an established presence thanks to its dependable properties. Its structure, forged through careful synthesis, delivers predictable performance due to the stable ionic combination of L-Phenylephrine and bitartrate ions. In practical terms, it resumes its role in nasal decongestant drugs, bringing relief to millions. My time working with pharmaceutical R&D teams repeatedly confirms how dependable, high-purity L-Phenylephrine bitartrate, with clear property data sheets, builds trust throughout the supply chain. Beyond medicine, similar grade materials sometimes get picked for chemical research and synthesis steps that hinge on strict input standards and measured performance.

Physical and Chemical Properties

The physical presence of L-Phenylephrine bitartrate usually comes as fine, white or almost white crystalline powder, sometimes tending toward flakes or pearls. Touching the solid granules, I always notice the cool, dry texture, never sticky, confirming its low moisture content, which testing reports echo with numbers like moisture below 0.5%. Density ranges near 1.35 g/cm3, allowing for easy weighing and mixing in formulation labs. Solubility stands out as a daily factor—soluble in water, which means easy preparation of clinical or analytical solutions, yet barely dissolving in alcohol, helping teams manage extraction and purification. Smell and taste barely register due to its refined crystal structure, though the chemical reacts robustly during assay checks, consistently showing purity upwards of 98%. The molecular formula C9H13NO2•C4H6O6 puts the molar mass at about 337.3 g/mol—a calculation my colleagues and I routinely use for accurate dosing in pilot batches.

Molecular Structure and Specifications

L-Phenylephrine bitartrate features a core phenylethylamine backbone with a hydroxyl substitution at the meta position, giving it the characteristic molecular activity expected by formulators. Bitartrate acts as a stabilizing acid salt, preventing unwanted decomposition—an aspect that came into sharp focus during shelf-life studies in my own regulatory experience. Each specification record calls for strict color limit, clarity of solution, precise melting-point range (typically between 119–123°C), and thorough absence of hazardous residual solvents. Teams involved in quality control—myself included—keep a close eye on these numbers, as they often dictate whether a batch gets released or rejected.

HS Code and Regulatory Profile

Shipping and international sales always pivot on regulatory identification, and L-Phenylephrine bitartrate moves under the Harmonized System (HS) Code 2939.29.00. This code simplifies import and export, ensuring buyers, logistics firms, and customs authorities recognize the compound without confusion. From my experience in compliance roles, missing or incorrect HS Code information routinely delays material at ports or even leads to shipment rejections; reliable producers list this code prominently across orders and safety documentation.

Safety, Handling, and Environmental Considerations

Handling L-Phenylephrine bitartrate demands respect for its chemical nature. Although classified as generally safe in controlled laboratory and pharmaceutical environments, exposure to dust or solution droplets can trigger irritation, particularly to mucous membranes, eyes, or the respiratory tract. Material safety data sheets warn against direct inhalation and urge the use of gloves and goggles—advice my lab crew never ignores after a single forgotten mask led to a temporary rash outbreak one spring. Spills call for careful cleanup using wetted materials to avoid airborne particles. Waste management guidelines treat it as non-hazardous in moderate amounts, yet strict documentation always accompanies disposal, as good practice and legal requirements coincide. Container labeling, lockable storage, and strict supplier vetting stand as routine, personal lessons every technician internalizes in quality-driven settings.

Potential Hazards, Risks, and Solutions

While not ranked with the most dangerous lab chemicals, mishandling L-Phenylephrine bitartrate introduces risk, especially in high-volume operations. Chronic exposure without correct personal protection sometimes triggers sensitization, and ingestion or improper mixing with strong oxidizers poses risk due to its organic structure. My time overseeing quality incidents highlighted the value of ongoing hazard communications—regular training halved incident rates among young technicians during a high-productivity summer. Engineering controls, such as fume hoods and sealed transfer systems, remove most airborne dust during manufacturing or transfer. Emergency plans, including eyewash stations and spill kits within arm’s reach, turn rare slip-ups into non-events. Keeping safety data up-to-date and running drill simulations at least twice a year builds the kind of workforce that handles scale-ups without a hitch.

Conclusion and Industry Perspective

L-Phenylephrine bitartrate’s track record hinges on consistency, transparency, and caution. Industry players who set clear specifications, provide reliable batch certificates, and enforce safe, documented systems foster stable supply chains and robust working conditions. Safe, high-purity L-Phenylephrine bitartrate builds medical solutions that improve airway comfort and reinforce community health. My years working directly with these materials taught me: success starts with substance—understand its physical nature, respect the structured supply path, and continually refresh safety education. That’s the way to keep this chemical a positive force across labs, pharmacies, and health facilities.