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Valine BP EP USP Pharma Grade stands out as a key pharmaceutical raw material, known for its purity and strict compliance with leading pharmacopeial standards. Valine, an essential branched-chain amino acid, forms a foundation in both medical and industrial settings for applications around protein synthesis, tissue repair, and metabolic regulation. It attracts attention across the pharmaceutical sector for its role as a building block for medicines, infusions, and specialized nutrition. The grade guarantees high standards for patient safety, product consistency, and regulatory acceptance in global markets.
Valine’s chemical formula, C5H11NO2, reflects its structure as one of the three branched-chain amino acids. Its arrangement offers a straight-chain carbon backbone that branches off with an extra methyl group. Molar mass clocks in close to 117.15 g/mol. Molecular density typically ranges between 1.23 g/cm³ and 1.25 g/cm³ in solid form, a feature that supports reliable measuring in both compounding and formulation processes. The property of being soluble in water with a solubility value near 8.5 g/100 mL at room temperature leads to easy dissolution, ideal for creating pharmaceutical solutions or parenteral dosage forms. Melting point remains consistent around 298°C (568°F), attesting to the high purity demanded by BP, EP, and USP standards. Its crystalline solid appearance varies: available as white powder, small flakes, or crystalline pearls depending on manufacturer and processing step.
Valine BP EP USP Pharma Grade usually fits under the HS Code 2922.49.99, which includes other amino acids and derivatives for international trade. This classification helps authorities and businesses handle customs, import-export compliance, and taxation. Adhering to British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP) specifications ensures acceptability for global pharmaceutical supply chains. Manufacturers provide certificates of analysis attesting to assay, purity, heavy metal content, and microbiological safety, all critical for passing scrutiny during regulatory audits.
As a raw material, Valine BP EP USP Pharma Grade typically appears as a white, odorless solid, offered in the form of crystalline powder, smaller flakes, or pearl-like granules. Bulk density ranges from about 0.6 to 0.8 g/cm³, which lets it flow and dispense well in automated equipment. Some pharmaceutical companies dissolve valine to prepare concentrated aqueous solutions, commonly at concentrations up to 5-10% w/v, which support IV infusions and enteral formulas. The powder disperses rapidly in water, remaining clear without sediment. Hygroscopic nature means valine may absorb moisture from the air under humid conditions; airtight storage, dry rooms, and tamper-proof packaging keep it stable during transport and long shelf-life.
Pharmaceutical grade valine forms a backbone in specialized mixtures for patients who cannot synthesize adequate amounts due to metabolic disorders, surgery, trauma, or chronic disease. Its role appears in parenteral nutrition, sports medicine supplements, clinical dietetics, and customized amino acid blends. Notably, producing injectable and oral formulations for hospitals or therapeutic compounds for rare diseases places high quality requirements on this grade of valine. Presence of even minor impurities can compromise drug safety and function, so strict manufacturing operations become mandatory for each batch. In my work supporting regulatory projects inside a pharmaceutical company, I saw how sourcing trusted valine decreased batch failure rates and stopped recalls tied to off-spec raw materials.
Valine BP EP USP Pharma Grade does not fall under hazardous chemical categories according to GHS or major regional regulations, but routine safety measures apply to avoid inhalation, skin or eye contact, and unintended ingestion. Workers handling bulk material in manufacturing plants wear standard personal protective equipment: gloves, lab coats, and masks. Valine’s environmental footprint counts as low; spills and residues are easily diluted in water and handled as biodegradable non-toxic waste. Fire risk remains minimal since valine resists ignition thanks to a high melting point and low volatility. Still, keeping chemical hygiene around raw materials storage helps avoid cross-contamination, accidental mix-ups, or compromised product integrity.
Maintaining product quality during storage calls for airtight containers, dry and cool environments (10–30°C), and away from light exposure. Given the critical use in sterile or parenteral preparations, manufacturers rely on GMP-certified facilities with robust monitoring of incoming raw material lots, batch records, and full traceability down to source. Physical properties—like density, solubility rate, and particle size—are checked with each shipment. Suppliers provide documentation such as Material Safety Data Sheets, Ph. Eur. or USP grade certificates, and validated test reports for every batch.
Valine BP EP USP Pharma Grade’s reliability as a pharmaceutical raw material means keeping close partnerships between manufacturers, distributors, and pharmaceutical customers. Recalls, product failures, or out-of-spec batches in the past year often tied back to switching suppliers, skimping on audits, or skipping full impurity screens. Developing open lines for reporting issues and sharing changes in formulation keeps everyone prepared and reduces costly downtime. As the pharmaceutical industry expands into emerging therapies requiring complex amino acid management, future improvements will lean on sources that guarantee traceable, consistent, and high-purity valine for life-saving medicines and innovative therapies.
Chengguan District, Lanzhou, Gansu, China
