(1R,2S)-2-(3,4-Difluorophenyl)Cyclopropanamine Hydrochloride BP EP USP Pharma Grade: In-Depth Commentary

What is (1R,2S)-2-(3,4-Difluorophenyl)Cyclopropanamine Hydrochloride?

(1R,2S)-2-(3,4-Difluorophenyl)cyclopropanamine hydrochloride stands as a key raw material in pharmaceutical manufacturing, positioned for use in complex synthesis and research. Its importance links directly to strict physical and chemical standards matched by BP, EP, and USP grades. The molecule belongs to the cyclopropanamine family, where the cyclopropane ring adds rigidity and specificity, playing a significant role in the bioactivity of finished pharmaceuticals. It carries a chemical formula C9H11F2N·HCl and has a defined molecular weight, typically around 209.65 g/mol, making it recognizable for handling, calculation, and application in laboratory and production environments. The fused presence of 3,4-difluorophenyl group broadens its range in medicinal chemistry, influencing the pharmacological profile and receptor selectivity found in active pharmaceutical ingredients developed from this structure.

Chemical Properties and Structure

The core structure features a cyclopropane ring substituted at the 2-position with a 3,4-difluorophenyl group, and an amine group, salt-formed into hydrochloride for easier handling and solubility. This precise stereochemistry—(1R,2S) configuration—results in a specific three-dimensional shape, directly affecting its interaction with biological targets and, ultimately, therapeutic effectiveness. As a hydrochloride, the compound expresses enhanced stability and shelf-life compared to its free base, protecting against atmospheric moisture and decomposing. Physical appearance varies by manufacturer and batch specifics, showing often as a white to off-white crystalline solid, with a powdery to flaky texture. It dissolves readily in water and other polar solvents, giving clear, colorless solutions at relevant concentrations. Melting point generally ranges from 165°C to 170°C, which supports identification and purity checks during material quality assessments.

Physical Characteristics and Forms

Laboratories and production facilities encounter this material primarily in solid form, spanning fine powders, compact flakes, or cohesive crystalline masses depending on processing and storage conditions. Handling requires care due to potential sensitivity to moisture; tightly sealed, light-resistant containers protect against degradation and clumping. In powder or flake form, the material weighs out efficiently for analytic and preparative use, enabling accurate dosing at milligram and gram scales. With density typically measured around 1.2 to 1.3 g/cm³ for the solid, process engineers consider bulk density and flowability during transfer and mixing steps. Optical properties, such as clear, colorless solutions when dissolved, benefit QC teams working on authenticity and contamination monitoring. Some facilities process intermediate solutions—usually measured in liter-scale volumes for pilot-scale reactions—which allow for controlled addition and minimal handling error.

Specifications, HS Code, and Material Handling

Whether the end goal is small batch drug discovery or industrial API production, strict specifications rule product acceptability. Purity requirements commonly exceed 98%, with residual solvent and related impurities held well below regulatory limits. Water content analysis through Karl Fischer titration ensures the absence of excess moisture, which impacts both shelf-life and reactivity. The assigned HS Code typically falls under 2921.19, categorizing it as an organic compound with nitrogen function, aiding in international trade tracking and customs processing. Documentation pairs every delivery with a certificate of analysis, ensuring that pharmaceutical-grade assurance stays uncompromised. Bulk transport tends to rely on secure, double-lined drums, tightly sealed bags, and temperature-stable conditions, minimizing the risk of accidental exposure or contamination during shipping and storage.

Safety, Hazards, and Environmental Impact

Direct contact with (1R,2S)-2-(3,4-difluorophenyl)cyclopropanamine hydrochloride presents standard chemical risks found in active synthetic intermediates. Although not classed as a major hazardous material, it demands attention for proper handling. Skin and eye protection, lab coats, and gloves limit the risk of irritation or accidental sensitization. Material Safety Data Sheets (MSDS) note its potential for mild toxicity if inhaled or ingested, with rare complications tied to the fluorinated phenyl group. Facilities serious about environmental stewardship pay attention to accidental release and waste protocols, using well-labeled, dedicated disposal streams to prevent mixing with incompatible chemicals. Exhausted containers and laboratory waste move through registered hazardous waste channels, following country-specific environmental rules. Training comes paramount—staff must recognize symptoms of accidental exposure, practice first-aid measures, and understand the need for thorough ventilation during weighing or solution preparation.

Challenges, Quality Needs, and Solutions

A consistent challenge lies in maintaining tight quality standards and minimizing variations batch-to-batch. Analytical techniques—NMR, HPLC, IR-spectroscopy—step in for rigorous fingerprinting and impurity profiling. Plants that manufacture this compound invest in advanced containment and drying technology to deliver material with predictable performance characteristics, lowering downstream risks for end-product failure. Reliable analytical protocols and clear specification sheets reduce ambiguity, preventing costly delays. To support safety, clear training documentation and regular refresher courses reduce the rates of handling mishaps or environmental release events. Environmental compliance grows in importance, rewarding suppliers who go beyond regulatory minimums by choosing cleaner synthesis pathways, closed-process recycling, and solvent recovery. Using this approach, companies not only ensure secure supplies but solidify public trust and regulatory approval on pharmaceuticals delivered to the market.

Concluding Thoughts on Raw Material Importance

Every raw material, particularly those with complex stereochemistry, like (1R,2S)-2-(3,4-difluorophenyl)cyclopropanamine hydrochloride, shapes outcomes and determines the consistency and safety of pharmaceutical products. By investing in supplier verification, material traceability, and modern handling infrastructure, manufacturers drive both innovation and consumer protection. This approach pays off long-term, ensuring that each dose delivered to patients owes its precision to careful selection, stringent process control, and deep respect for the science behind pharmaceutical chemistry. Experience shows that a few extra steps to guarantee the quality and safety of such materials save significant troubles downstream, keeping the focus on efficacy and patient well-being.