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Histidine belongs to the group of essential amino acids, found in proteins across the living world and critical for a healthy body. Its hydrochloride variant, made by combining histidine free base with hydrochloric acid, provides a stable salt form, boosting its solubility and ease of use. This specific pharma grade follows British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP) standards, which means purity and consistency get rigorous attention. In medical and biopharmaceutical production, these standards safeguard quality from raw material sourcing to packing. Histidine, in this grade, supports clinical nutrition, buffers in injectable preparations, and finds its way into cell culture solutions, showcasing the reach of this relatively humble molecule.
The essential chemical nature of histidine stands out through its imidazole functional group, bridging the worlds of proteins and enzymes. Its molecular formula is C6H9N3O2, with a molecular weight of about 155.15 g/mol for the free amino acid. The hydrochloride salt, histidine hydrochloride monohydrate, weighs in at about 209.64 g/mol and follows a formula of C6H9N3O2·HCl·H2O. Beyond numbers and atoms, the imidazole ring gives this molecule a means of buffering—regulating pH in physiological and laboratory systems, an invaluable property for injectable drugs and cell nutrition.
Histidine tends to appear as white to off-white crystalline powder, though you might also spot it as small, fine flakes, or in some cases as granules or pearls. The hydrochloride salt keeps a solid, crystalline look, favoring the pharmaceutical industry's demand for clean, readily processed ingredients. Density typically floats around 1.4 g/cm3 for both the base and the hydrochloride, fitting seamlessly into both aqueous solutions or solid mixtures. While this compound dissolves easily in water, it resists in most organic solvents, allowing for targeted application in clinical products and biological research. Its taste—if ever encountered directly—is slightly bitter, common to many amino acids and their salts. Such taste profiles mean little for direct medical use but act as sanity checks during quality assurance.
Manufacturers work tightly to meet pharmacopoeia monographs, with purity usually reaching 99% or higher for pharma grade. Impurity profiles, loss on drying, specific rotation, and residue on ignition remain under close scrutiny during testing and release. Heavy metals, microbial content, and endotoxins all sit under strict regulatory limits, because injectable and nutritional uses allow almost no space for error. The material responds positively to ninhydrin, confirming the presence of amino acid groups. pH, once in solution, usually settles near neutral, a favorable aspect for biological compatibility. Granularity, flow rate, and bulk density matter more to those preparing large-scale media, but these values tend to stay consistent batch after batch when working with a trusted pharma grade supplier.
Within world trade, histidine and similar amino acids fall under the HS Code 2922.49 for histidine under the harmonized system. This code supports government tracking, customs protocols, and helps import/export processes move smoothly across borders. It may feel bureaucratic, but efficient identification lets industries, governments, and regulators distinguish pharma-grade compounds from feed or industrial grades. It prevents accidental misrouting and safeguards the stringent purity required for injectable or oral medicinal use.
In pharmaceutical settings, histidine gets made into solutions ranging from milligram to gram per liter (mg/L to g/L), offering stable buffers for protein biologics and vaccines. Density of these solutions depends on concentration, but accurate preparation means the compound delivers expected pH and buffering capacity every time. Whether reconstituted as a sterile injectable or measured for a cell culture medium, precision in preparation supports reliable, repeatable outcomes for sensitive biological systems. Solid forms enjoy longer shelf lives when properly sealed from humidity.
Even familiar amino acids require responsible storage and handling. Histidine and its hydrochloride don’t rank as highly hazardous for short-term exposure—dust or powder may cause irritation to respiratory tract or mucous membranes, so proper personal protective equipment (PPE) like gloves, goggles, and masks keep handling safe. Use of local exhaust or dust controls matters in larger-scale settings. Spills clean up with regular protocols, but as with any pharma ingredient, cross-contamination with unrelated chemicals is not an option. This lets medical and research products avoid undeclared allergens and impurities. Disposal of waste sticks to local environmental guidelines, since even non-hazardous biological materials can stress water treatment systems.
Manufacturers and research teams select BP EP USP pharma grade histidine because it stands as more than just a chemical—it guarantees rigor, transparency, and patient safety. This transparency and accountability matter to regulatory bodies, clinicians, scientists, and patients alike. Analysis by high-performance liquid chromatography (HPLC), mass spectrometry, and microbe testing anchor this trust, building confidence batch after batch. Whether entering the bloodstream as an excipient, nourishing growing cells, or acting as a pH buffer for critical vaccines, histidine supports some of the most demanding applications on earth. With rigorous raw material oversight, research and medical teams focus on outcomes: better health, scientific breakthroughs, and patient safety at the front line.
Chengguan District, Lanzhou, Gansu, China
