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Pregabalin, with the molecular formula C8H17NO2, shows up as a white to off-white crystalline solid. This material, classified under the HS Code 29224995, serves as an essential product in pharmaceutical manufacturing, meeting rigorous BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia) standards. Each of these standards sets detailed requirements to maintain high product purity and consistency. The chemical carries the IUPAC name 3-(aminomethyl)-5-methylhexanoic acid, and its molecular structure contains an isobutyl core substituted with an amino and a carboxyl group. Pregabalin’s stable form at room temperature supports its handling and storage across different climates, ensuring reliability in raw material supply lines.
Pregabalin BP EP USP Pharma Grade appears as a crystalline powder or as colorless flakes, depending on processing methods. The solid form supports easy weighing and accurate compounding in the pharmaceutical industry. Average particle size and bulk density play pivotal roles for formulators. Its specific gravity hovers near 1.1 g/cm³, providing a stable base for mixtures that get pressed or filled into capsules. This chemical remains almost insoluble in nonpolar solvents but offers great solubility in water and ethanol, making it easy to prepare accurate doses for clinical and lab uses. Whether it’s delivered in flake, powder, or occasionally pearl form, every batch undergoes strict control for moisture content, polymorphism, and foreign particles to ensure batch-to-batch consistency. Pregabalin’s melting point lands near 194–196°C, assisting in confirming product identity and purity. Materials come packed for protection from light and moisture, as required by pharmacopoeial standards, directly supporting product stability from warehouse to laboratory.
At a chemical level, Pregabalin’s structure includes a single chiral center, making enantiomeric purity vital for medical safety and performance. Not just a simple amino acid derivative, it displays low reactivity with common excipients, so it behaves predictably in pharmaceutical blends. Its distinct stereochemistry gives Pregabalin the therapeutic value that separates it from generic analogues or lower-quality substitutes. Every molecule carries both an amine and a carboxylic acid group, giving the substance amphoteric properties—meaning it can interact with acids and bases during formulation. This affects solubility, bioavailability, and stability in finished products, so pharmacists and chemists examine both molecular weight, at 159.23 g/mol, and crystalline form with close attention.
Pregabalin in BP EP USP Pharma Grade stands out for high purity, exceeding 99% on a dry basis, and tends to show minimal impurity profile after synthesis. Analytical techniques such as HPLC, IR spectroscopy, and NMR confirm molecular identity and rule out chemical degradation or adulteration. Its relative chemical inertness means it rarely reacts with standard packaging or manufacturing aids, letting it maintain its efficacy when properly stored. The raw material demands anhydrous conditions and temperatures below 25°C because it can absorb atmospheric moisture, sometimes clumping if left exposed. The product is not especially volatile or prone to oxidative breakdown, which supports longer shelf life and easier regulatory transport.
Standard lots of Pregabalin BP EP USP Pharma Grade come marked with full certificates of analysis, batch numbers, and expiry details, all necessary for compliance with global medicine regulations. Spec sheets confirm properties such as assay, loss on drying, pH in aqueous solution, identification by chemical and spectroscopic methods, specific optical rotation, and residual solvent levels. The specifications stop short of letting any measurable levels of toxic metals, harmful solvents, or foreign particles slip through, ensuring safety in the supply chain. Pregabalin qualifies as a hazardous substance only in concentrated or bulk handling scenarios, mainly due to chemical dust and possible misuse, so robust safety protocols—lab coats, gloves, masks—never get skipped. Labels warn of skin and respiratory irritation, so storage means lock-tight, well-ventilated rooms, separate from strong acids or oxidizers that might trigger a hazardous reaction.
This raw material goes straight into capsule and tablet formulation for neuropathic pain and anxiety management. Every company in the industry wants the same thing: a product that flows well, presses evenly, and resists breakdown through shipping, processing, and final packaging. Pregabalin’s fine particle size means it blends easily with fillers like lactose or cellulose. The material remains free flowing, which cuts down production blockages and supports accurate dosing in automated tablet presses. In work environments, worker exposure stays low when operators use local exhaust and personal protective equipment. Many facilities automate powder transport to cut back on spill risk and reduce environmental contamination, which brings the added bonus of keeping potent pharmaceuticals out of the general surroundings.
The supply of safe, high quality Pregabalin starts at the raw material stage. Reputable manufacturers invest heavily in source verification, vetting chemical intermediates, and ensuring each kilogram meets strict pharmaceutical standards. Audits help expose weak spots, like impurities that slip in from subpar synthesis steps or storage in the wrong conditions. As a pharmaceutical-grade raw material, Pregabalin demands chain-of-custody tracking and near-continuous documentation for every handoff from synthesis to finished product. Small errors—a little too much moisture, a few parts per million of the wrong impurity—show up in downstream tests. Regular external testing, not just in-house analysis, keeps both suppliers and customers honest.
Pregabalin BP EP USP Pharma Grade comes with clear guidelines for safe handling, storage, and disposal. Like most potent chemicals, it can cause mild irritation on skin contact and respiratory exposure to airborne dust. Training for staff explains why spills receive careful cleanup and why materials need airtight containers and away-from-kids labeling. Spill kits, gloves, and fume hoods stay close by in production rooms where scale-up projects get messy, often in larger amounts than most people realize. Waste Pregabalin heads for proper disposal, usually by licensed chemical disposal contractors who keep residues out of landfills and waterways.
Pregabalin’s status as a controlled substance adds a layer of complexity to every transaction. Legal regulations and reporting requirements mean suppliers, buyers, and shippers keep a relentless paper trail. Counterfeiters and supply chain fraud, spurred by high demand and value per kilogram, pose a real threat. Pharmacies and manufacturers must verify certificates, use trusted vendors, and push for digital tracking on every transfer to stay one step ahead of exploitation and product diversion. Efforts to green the supply chain focus on solvent-free synthesis and recovery of raw materials where possible. Every kilogram made sustainably is one less chemical hazard downstream. International consensus on testing, documentation, and supply chain transparency builds public trust, delivers safer medicine, and ensures people in pain receive exactly what their doctor prescribed—nothing less, nothing more.
Chengguan District, Lanzhou, Gansu, China
