Chengguan District, Lanzhou, Gansu, China sales01@liwei-chem.com 1557459043@qq.com
Follow us:



Tranexamic Acid BP EP USP Pharma Grade: An In-Depth Perspective

What Is Tranexamic Acid BP EP USP Pharma Grade?

Tranexamic acid BP EP USP Pharma Grade is not an obscure name on a chemical register; it plays a major role in the world of pharmaceuticals and medicine. With the molecular formula C8H15NO2, it steps in as a synthetic derivative of the amino acid lysine. In form, this material stands out because of its versatility: it comes as a white crystalline solid, though one may also spot it as a fine powder or sometimes even as pearls. Talking about the structure, it is well-defined—easy to handle in a laboratory or a production facility. The real magic lies in its antifibrinolytic property. By blocking the activation of plasminogen to plasmin, it slows the breakdown of blood clots, which becomes crucial during surgical procedures, trauma, and certain bleeding disorders. I have seen it valued in clinical settings for this exact reason—providers look for reliability in raw materials like this.

Key Physical and Chemical Properties

Tranexamic acid draws attention for purity and for staying within recognized international pharmacopeial standards, specifically BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia). Each of these certifications reassures stakeholders in the supply chain, from raw materials procurement managers to pharmacists and researchers. The substance features a specific melting point of around 300 °C and demonstrates strong solubility in water, which means even in solid or powdered form, it can transition to a clear solution with ease. Its density sits at about 1.2 g/cm³, signaling a compact and manageable material for storage or transport. In the real world, those handling bulk shipments notice that the solid flakes or fine powder pack efficiently into drums and bags, saving space and simplifying inventory tracking.

Structure, Composition, and Forms Available

With a molecular weight of 157.21 g/mol, every gram counts in both small and large-scale applications. The crystalline appearance—sometimes likened to tiny flakes or granular powder—makes it simple for chemists to verify authenticity without sophisticated equipment. Liquid or solution grades also exist when applications want smoother and quicker dissolution, especially for intravenous use. The core chemical structure, based on trans-4-aminomethylcyclohexanecarboxylic acid, remains stable under normal conditions. This reduces concerns about spoilage or hazardous reactions during storage, and it's one advantage procurement staff often look for. For laboratory audits and pharmaceutical quality assurance, each batch comes with batch-specific documentation, including HS Code 29224985, aligning it with international trade for organic compounds.

Specifications and Standards

The significance of Tranexamic acid BP EP USP Pharma Grade goes beyond just formulas or commercial codes. The strict adherence to specifications sets the bar for raw material selection in pharmaceutical manufacturing or clinical use. Specifications generally include high purity (not less than 99%), very low impurity profile, regular particle size for powders, and limited moisture content. Samples undergo rigorous tests for melting point, solubility, specific rotation, heavy metals, and other trace elements, reflecting a culture of safety around its production. Responsible sourcing isn’t a buzzword here; pharma companies know any deviation in grade or quality cascades straight into finished drugs, where patient safety cannot take a back seat.

Safe Handling and Raw Material Context

Practitioners treating bleeding conditions keep a close eye on the safe handling protocols. Inhalation, ingestion, or direct skin contact should not happen in casual settings, as with any potent chemical. Strong storage protocols—well-sealed containers, low humidity, stable ambient temperature, and clear isolation from incompatible substances—must stay in place throughout the raw material life cycle. This behavior lines up with its hazardous nature; the substance qualifies as harmful if mishandled. Industrial use follows established protocols under applicable regulations like REACH, GHS, and other workplace safety acts.

Importance in Pharmaceutical Manufacturing and Application

Many do not see what unfolds behind the scenes in hospital environments, where doctors manage acute bleeding with life-saving drugs that rely on pure, standardized raw material. Tranexamic acid, thanks to its certified grade and proven batch consistency, shines in injectable formulations, tablets, and topical solutions. It enables pharmaceutical companies to meet regulatory approvals and obtain certifications without guesswork. Raw material suppliers, especially those dealing with bulk custom orders, bank on a reliable HS Code and detailed molecular property logs for every shipment, helping match the legal, safety, and efficacy requirements across different countries.

Points for Improving Transparency and Safety

Looking at problems that arise with bulk chemical sales, the need for better data tracking and improved documentation stands out. Global trade in pharmaceutical raw materials depends not just on a chemical's properties, but also on transparency, traceability, and stewardship over the supply chain. Fake or substandard products can lead to significant harm; strict adherence to BP EP USP quality eliminates much of this risk. For long-term safety, companies could invest further in real-time monitoring systems for purity and contaminant detection, not just at point of manufacture but through transport and delivery. Looking ahead, digital batch tracking, QR-coded batch certificates, and secure supply chain management hold the key.