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Alanine BP EP USP Pharma Grade is a synthetic form of the non-essential amino acid alanine prepared to meet three of the globe's top pharmacopoeial standards: British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP). This grade of alanine finds its use in pharmaceutical manufacturing and lab analysis, prized for its consistency, purity, and defined physico-chemical characteristics. Produced through controlled processes, this material offers high batch reproducibility, required for any pharmaceutical product’s integrity and performance.
Alanine occurs as a solid at room temperature and comes in several forms such as white or nearly white crystalline powder, flakes, pearls, or even as a granulated solid, each version having slightly different handling properties. The molecular formula for alanine is C3H7NO2, and its structure consists of a methyl group attached to the alpha carbon of the amino acid backbone, granting it both hydrophobic and water-soluble characteristics. The powder form flows freely, clumps little, and slips easily into pharmaceutical blends, while the crystalline type dissolves rapidly in water, making it useful in liquid preparations. Its molecular weight stands at about 89.09 g/mol, so bulk calculations stay transparent. The compound's density typically ranges from 1.4 to 1.5 g/cm3 depending on solid packing.
Sourced for the strictest product applications, Alanine BP EP USP Pharma Grade must meet multi-pharmacopoeial requirements: high purity (often not less than 99.0%), low total impurities, and reliable identity confirmation. Key tests check optical rotation, clarity and color of solution, pH, heavy metals (usually under 10 ppm), and loss on drying. Typical particle size distribution ranges from fine powder to larger crystalline units, suitable both for direct compression or solution blending. International shipment and regulatory traceability use HS Code 29224985, assigned to amino acids and their derivatives, which facilitates customs clearing and documentation worldwide. Professional operators often prioritize these certifications for specific drug synthesis or parenteral nutrition.
In production, the bulk density will matter for mixing, transport, and storage. As a crystalline or powdered product, alanine is easy to transfer, doesn't cake up much, and requires less aggressive machinery to process. In solution, alanine behaves as a neutral amino acid, with solubility upwards of 167 g/L at 25°C, ensuring rapid incorporation into aqueous pharmaceutical formulations. It stays stable under standard room conditions, in either a sealed solid or dissolved state, for long stretches—crucial for supply planning. On a small scale, I found that this property let us prepare standard solutions days ahead with no loss in performance or reactivity.
Working with raw materials for pharmaceutics, safety stays at the front of every operation. Alanine doesn’t fall under the list of hazardous chemicals under GHS or CLP regulations. No acute toxicity to humans at occupational doses, no carcinogenicity, and no environmental threat under normal use. Contact with eyes or open wounds causes mild irritation at worst, and ingestion at unintended levels brings little risk—just moderate digestive upset for some. During blending and transfer, the dust can become a mild inert nuisance, managed easily with dust extraction or respiratory masks. Storage involves keeping the product cool and dry, tightly sealed, and away from sources of contamination.
Pharmaceutical and biotechnological use draws from alanine’s dependable building-block status. In parenteral nutrition and IV formulations, this amino acid delivers the right nutritional dose because of its straightforward metabolism in the human body. Multivitamin and amino acid preparations favor BP EP USP grades for their trusted analytical history and purity. Laboratory work uses this material as a reference standard in chromatography, a substrate in enzyme assays, or a pH buffer ingredient due to the compound's zwitterionic nature at physiological pH. My experience in pharmaceutical analysis proved that batch-to-batch consistency in alanine lets us calibrate equipment confidently, and when formulating high-value solutions, only pharmaceutical-grade stuff gives peace of mind on purity and traceability.
Market data shows the annual demand for alanine continues to grow in clinical nutrition and injectable therapy. Large-scale production follows validated procedures to guarantee residual solvents and heavy metals stay within pharmacopeial limits, often less than 0.1%. Independent lab certifications and transparent chain-of-custody documents underscore product reliability—these records turn vital if an audit or recall sweeps through the supply chain. Traceability by batch number, HS Code, and lot-specific analytical data becomes non-negotiable. Companies who ignore the need for detailed records risk product seizure or destroyed inventories if authorities find specification deviation.
The industry faces rising demand for amino acids with both high purity and environmental responsibility. Energy-efficient production processes, better waste management, and green synthesis routes can further reduce alanine’s environmental impact. Material in powder or flakes form could come with even tighter particle size distribution, supporting both better blend uniformity and less dust. Widely available safety data sheets help, but more transparency on upstream raw material sourcing would satisfy the growing call for sustainability and ethical procurement. As biotech evolves, more precise quality testing—perhaps with near-infrared or Raman spectroscopy for onsite inspections—can bolster purity assurance and support next-generation therapies.
Chengguan District, Lanzhou, Gansu, China
