(R)-(-)-Norepinephrine L-bitartrate Monohydrate: A Comprehensive Look

What is (R)-(-)-Norepinephrine L-bitartrate Monohydrate?

(R)-(-)-Norepinephrine L-bitartrate monohydrate draws attention in chemical and pharmaceutical manufacturing due to its distinct structure. It acts as a salt form of norepinephrine, bonded to L-bitartrate and stabilized with one water molecule per unit. This combination impacts how the product handles, mixes, and stores, especially in processes seeking higher stability and purity from raw materials. Production teams regularly report challenges in managing compounds that absorb moisture, yet the monohydrate mitigates some risks by locking water into its crystal lattice. From the perspective of supply teams, recognition by regulatory bodies renders it easier to import and export, a small yet vital advantage in cross-border pharmaceutical work.

Physical and Chemical Properties

In laboratories and warehouse settings, (R)-(-)-norepinephrine L-bitartrate monohydrate shows up as solid white to off-white flakes or crystalline powder. It doesn’t look flashy, but its apparently bland surface conceals a hidden complexity. People who have handled this compound will notice its granular feel when in powder form and its tendency to hold together loosely in flakes. The density, often cited between 1.45 to 1.55 grams per cubic centimeter, stands at the midpoint among similar salts, making it manageable in both small and large batch mixing. Its molecular formula, C8H11NO3·C4H6O6·H2O, supports a molecular weight of about 337.32 g/mol. Technicians keep an eye on how easily it dissolves in water, a property essential for pharmaceutical compounding where quick and predictable solubility helps streamline downstream reactions. Handling teams appreciate that it blends well into aqueous solutions, forming clear, almost colorless mixtures at room temperature.

Structure and Molecular Formula

Structural detail lies at the heart of this compound’s value. The norepinephrine base features a catechol ring, two hydroxyl groups in ortho positions on a benzene ring, and an ethylamine group. This arrangement behaves predictably in receptor binding assays and underlies why chemists select this over other adrenergic agents. The bitartrate counterion balances the basicity of norepinephrine, increasing shelf life and permitting tighter control over release rates in formulated medications. Laboratory reports highlight that the monohydrate’s hydration prevents caking—a problem with anhydrous versions—leading to fewer clogs in manufacturing systems. The crystalline texture, visible under a good microscope, stems from both the hydrogen bonding in the tartaric acid portion and the orientation of norepinephrine molecules. Raw material teams confirm that this structure resists oxidation better than free base analogs, cutting down losses from deterioration during storage.

Specifications and Material Handling

Fragmented supply chains have shown that consistent sourcing remains tough. Companies focus on verified raw material, checking purity above 98%. Common specs demand loss on drying under 5%, minimal heavy metal presence, and strict microbiological limits. Each kilogram typically arrives packed in airtight, light-resistant drums or double-lined bags, since light and air introduce instability risks to the catechol moiety. Manufacturing staff, responsible for health and safety, often note low-to-mild hazard warnings: the powder may irritate eyes, skin, and respiratory tracts. Proper PPE—gloves, goggles, and dust covers—helps prevent accidental contact. Cleaning crews deal with fine particulate; equipped with HEPA filters, they reduce airborne dust and cross-contamination. The raw powder remains stable for at least two years under cool, dry warehouse conditions.

HS Code and Regulatory Background

International logistics specialists know the HS Code 2939.11 covers epinephrine and its salts, which includes (R)-(-)-norepinephrine L-bitartrate monohydrate. Customs paperwork, tariffs, and documentation all reference this code, smoothing path for border crossings. Regulators in the US, EU, and Asia enforce demanding standards for traceability and purity in pre-approval phases. Importers need material safety data sheets conforming to GHS recommendations, detailing every hazard from acute toxicity to aquatic effects. Multi-site manufacturers track all batches by lot number as international norms keep tightening with each regulatory update.

Forms: Solid, Flakes, Powder, Pearls, Liquid, Crystal, Solution

Whether sourced as coarse flakes or fine powder, (R)-(-)-norepinephrine L-bitartrate monohydrate rarely arrives as pearls or liquid due to its inherent properties. Some pharmaceutical firms prepare crystalline versions for high-purity needs, often using chromatography-based refinement. Solution forms typically surface in research labs, made up fresh to achieve predictable dosing in animal studies or cell work. Each form answers a distinct workflow: large flakes make weighing fast for bulk processing, while fine powder suits automated pipetting and blending in high-speed environments. Crystals attract those who prize slower dissolution for modified-release projects. Companies rarely offer this material as a liquid due to quick degradation and strict temperature requirements. Most staff, from QC to logistics, agree that solid forms provide the best balance between stability and hassle-free storage.

Safe Use, Hazards, and Environmental Considerations

Day-to-day handling reveals risks most obvious to seasoned staff. Fine particles spark allergic or asthmatic responses if inhaled, so good ventilation and personal respirators matter for prolonged tasks. It burns eyes and stings skin upon contact, earning a classification as harmful but not severely toxic. Accidental release grounds in neutral, dry absorbents, carried off in sealed waste containers. Eco-conscious facilities contain runoff, referencing local hazardous chemical handling guidance. Down the line, spent solutions and residues enter designated disposal streams for organic chemicals. People share firsthand stories about lessons learned during spills—slow work and diligent use of spill kits will always trump cleaning shortcuts. Long-term, the greatest risks stem from improper storage: overheating or poor sealing hastens decomposition, so warehouse teams invest in clear labeling and regular inventory rotation.

Role as Raw Material in Pharma and Research

Pharmaceutical teams value (R)-(-)-norepinephrine L-bitartrate monohydrate for its reliability in synthesis of adrenergic drugs and cardiovascular support agents. Finished medicines count on it for precise dosing, which begins with the high assay purity of incoming raw stock. Oncology and cardiology labs run preclinical animal studies with its buffered solutions, where batch reproducibility underpins every finding. Researchers watch carefully for evidence of breakdown impurities—just one misstep, and entire runs lose consistency. In formulation development, its granular texture lets development chemists calibrate drug release profiles with fine control. Blending and mixing staff prefer materials that do not clump, and so the monohydrate’s stable powder plays well in automated environments.

Potential Solutions for Common Issues

Procurement professionals, facing sudden supply chain shocks, benefit from developing partnerships with alternate sources and investing in in-house stability testing. To guard against moisture intrusion, many opt for vacuum-sealed packaging with desiccant packs. Training programs for warehouse staff cover spill containment and thermal safety—cutting reaction times and improving safety records. On the manufacturing floor, real-time dust management tools add a layer of worker protection, while QC labs run more frequent impurity scans to catch problems early. In organizations running at scale, centralized tracking systems ensure that every drum and batch gets used before expiry, shrinking losses and protecting the bottom line.