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Histidine BP EP USP Pharma Grade shows up in the world of pharmaceutical raw materials as a crucial amino acid, classified as essential due to the human body's need to source it from outside, rather than relying on internal production. In the laboratory and in industry, this grade of histidine delivers rigorous compliance with the detailed requirements of the British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP), making it a preferred choice for formulating medications designed for intravenous infusions, parenteral nutrition, and other therapeutic applications. Histidine is recognized by its molecular formula, C6H9N3O2, and a molar mass around 155.15 g/mol, placing it neatly among other standard amino acids. Its categorization includes a specific HS Code—usually 2922.49.99—indicating its unique position among unlisted amino acids for global trade purposes. Belonging to the family of polar, positively charged amino acids, histidine holds a special function with its imidazole side chain, which contributes to buffering and enzymatic activity in both pharmaceutical and biotechnology settings. Its significance stands out because of its strict grade, which assures tight controls on purity, microbial limits, heavy metals, and endotoxins.
Histidine appears as a solid material under normal conditions, generally presenting as either white crystalline powder or free-flowing flakes, depending on the manufacturer. The melting point tends to center around 277°C with decomposition, pointing to its thermal stability, but it rarely finds use at these high temperatures due to limitations in practical settings. It carries a density of about 1.56 g/cm³, which I find useful when planning solutions, as density and solubility can impact the handling of both bulk and finished product. Its solubility in water reaches up to 41 g/L at room temperature, allowing for easy dissolution when preparing stock solutions in the laboratory or compounding pharmaceuticals. As someone who has handled histidine solutions, knowing it forms clear, colorless liquids upon dissolution—without unwanted particulate—sets a reliable expectation for both quality and ease of use. In terms of chemical structure, the molecule features an aromatic imidazole ring joined to an α-amino group and a carboxyl group, setting up that familiar zwitterionic balance that can accept both protons and electrons, making histidine a common buffer component in biochemical assays and nutritional formulations.
Looking at the specifications detailed in pharmacopeia monographs, histidine BP EP USP Pharma Grade sets limits for purity much higher than forms used in technical or food grades. Manufacturers target assay values above 98.5% (on a dried basis), limiting impurities such as heavy metals (often under 10 ppm), with strict controls on microbial contamination (total viable count not exceeding 100 cfu/g, for example), endotoxin content, ash, total metals, and specific organic impurities. Moisture content remains low, with a typical Karl Fischer result or LOD (Loss on Drying) below 0.5%, ensuring stability and minimization of degradation during storage. It comes to market most often in solid forms—mainly powder or crystalline flakes, though some facilities may shape it as “pearls” or micro-pellets for process convenience and flowability. While it can dissolve to make a colorless solution, I rarely see it handled in a liquid state except in freshly prepared buffer solutions or injectable admixtures. Whether shipped in multi-layer bags with protective liners for moisture control or in container drums, each batch preserves traceability—essential for end-users in regulated environments from hospitals to research labs. Bulk density hovers around 0.4-0.6 g/cm³ depending on the crystalline form, which carries practical implications for storage logistics and mixing during further processing.
The molecular formula, C6H9N3O2, stands out as a signature of this amino acid, revealing exactly what’s inside every molecule. With a clear understanding of its elemental makeup, chemists and buyers can trace origin, confirm identity, and catch any deviations from the authentic structure using modern analytical methods. Histidine’s imidazole ring—unique among natural amino acids—provides distinct reactivity, a fingerhold for enzymes and receptors in the body, and a preferred binding site in metal chelation and protein stabilization. This property goes beyond the test tube, making histidine vital in metabolic regulation, pH buffering, and as a precursor for biologically active molecules like histamine. In my experience, the clear assignment of this molecular structure through NMR, IR, and MS (mass spectrometry) delivers peace-of-mind, especially when purity and safety drive the production standards. End users and regulators alike expect this structure to be consistent, batch after batch, and deviation triggers immediate investigation.
Bulk histidine BP EP USP Pharma Grade counts as a comparatively safe chemical. Acutely, it carries a low toxicity profile—oral LD50 values (for rodents) report levels above 5 g/kg, indicating modest risk in most handling situations. Inhalation of dust may cause mild respiratory irritation, so wearing a dust mask during weighing or transfer pays off with less risk. Prolonged skin contact, while rare in routine pharmaceutical labs, may occasionally cause irritation, so gloves belong in every standard operating procedure. In my direct experience, keeping the workspace clean, using contained transfer systems, and routinely checking local exhaust ventilation prevents unnecessary exposure. Regulatory bodies do not classify histidine as hazardous under GHS (Globally Harmonized System), but every batch comes with an SDS (Safety Data Sheet), spelling out specific storage, handling, spillage, and fire-fighting guidelines. Fire risk remains minimal since it does not ignite readily, but it’s wise to segregate histidine from oxidizers and acids to avoid unwanted reactions. Under normal storage, away from light and moisture, the solid keeps for years, keeping integrity until needed for critical pharmaceutical manufacturing or research.
Pharma manufacturing takes histidine from raw material status to finished ingredient with precision, particularly for parenteral nutrition solutions (TPN), infusion therapies, and certain injectables that rely on its buffering action and physiological relevance. Its imidazole side chain makes it more than a structural building block—it acts as a mild buffer in the pH 5.0-7.0 range, matching the body’s conditions and ensuring product stability and patient comfort. It underpins peptide synthesis, vaccine development, and cell culture media as well, earning its place in both medicine production and advanced research. Roadblocks sometimes arise in sourcing high-purity histidine or assuring consistent supply, especially as global demand rises or manufacturers face tightening quality regulations. From what I’ve seen, diversifying sources, supporting GMP-compliant local production, and investing in analytical verification for each incoming lot address most challenges. It pays long-term dividends to build robust partnerships with verified suppliers, keep a batch archive for future comparison, and stay attuned to changes in regulatory expectations or new evidence about its safety and performance. Whether formulating large molecule therapies or targeted nutrition products, the certainty that comes from using BP EP USP grade histidine reflects a blend of scientific discipline and a stubborn commitment to patient safety.
Chengguan District, Lanzhou, Gansu, China
