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Relebactam BP EP USP Pharma Grade serves as a pharmaceutical raw material known for its use in the synthesis of anti-infective agents, especially where advanced beta-lactamase inhibition is required. The compound falls under the category of beta-lactamase inhibitors, working in synergy with certain antibiotics to block resistance mechanisms in pathogenic bacteria. Laboratories and active pharmaceutical ingredient (API) producers often require materials that exceed basic compliance, and Relebactam in its pharmacopeial grades (BP, EP, USP) provides that reliability through strict physical and chemical characterization.
Relebactam carries the molecular formula C12H12N4O5S and presents itself typically in a solid form. In appearance, it ranges from white to off-white powder, sometimes observed as crystalline flakes or fine granules, depending on manufacturing technique and storage conditions. Its specific structure features both cyclic and acyclic moieties, centering on a diazabicyclooctane scaffold that offers stability under normal handling but sufficient reactivity in target applications. Chemically, it is classified as a non-aromatic, sulfur-containing, nitrogen-rich molecule.
Manufacturers and importers handle Relebactam under strict regulatory oversight, tied to the Harmonized System Code 293499 and dictated by international customs and safety standards. At the point of quality control, typical specification values get measured—purity commonly exceeds 98.0%, water content remains below 1.0%, and residual solvents stay within pharmacopeial limits. Melting point generally falls in the range of 180°C to 190°C, indicating strong lattice forces within its crystal structure, important for stability and shelf life.
Solid batches of Relebactam typically register a bulk density near 0.40–0.60 g/cm³, which matters both for process handling and formulation scaling. In solubility tests, Relebactam shows moderate water solubility and greater dissolution in polar organic solvents like dimethyl sulfoxide and methanol—key for both analytical quantification and pharmaceutical formulation. Most storage recommendations point to cool, dry conditions, using airtight containers composed of HDPE or glass to protect from moisture uptake and decomposition.
Occupational chemists and pharmaceutical operators understand the significance of safe handling. Relebactam, at pharma grade and high concentrations, demands respect as a chemical raw material, with precautions focusing on inhalation or direct skin contact. Material Safety Data Sheets (MSDS) and packaging labels document its hazard code: irritant for skin and eyes, and harmful if ingested or inhaled in concentrated form. Standard operating procedures call for gloves, goggles, dust masks, and careful use of ventilated areas or fume hoods. Waste must be managed in line with both local environmental guidelines and specific chemical regulations to prevent inadvertent contamination.
Quality in pharmaceutical manufacturing depends on traceability. Suppliers guarantee batch-to-batch consistency through validated analytical methods such as HPLC, mass spectrometry, and NMR for structure confirmation, as well as extensive impurity profiling. Storage and distribution channels keep a rigid chain of custody, ensuring that every lot entering a production facility traces back to verified origin and meets the declared specifications. Certificates of Analysis (CoA) accompany shipments, listing all essential test results, including molecular identity, purity, density, and absence of hazardous residues.
Every reputable laboratory puts Relebactam through analytical scrutiny before accepting a shipment for research or API conversion. Mass spectrometry provides the precise molecular weight, confirming compound identity. NMR spectroscopy and FTIR assignments back up primary purity assertions, while titration and Karl Fischer analysis measure water or solvent content. Stability samples undergo periodic testing to rule out polymorphism, crystallinity changes, or presence of decomposition byproducts—all of which can impact pharmaceutical formulation and bioavailability.
In the broader pharmaceutical value chain, Relebactam sits within the roster of essential beta-lactamase inhibitor building blocks. Bulk stocks feed directly into synthesis or co-formulation with partner antibiotics, relying on its physical properties (powder, flake, granule, crystalline solid) to dissolve or mix with minimal loss or wastage. Once blended or reconstituted in solvent, it forms part of sterile injectables or oral tablets, and each handler takes responsibility for maintaining physical integrity from start to finish—starting from receipt of the raw solid through every intermediate storage and final dispensing in formulation areas.
The increasing emergence of beta-lactamase resistance has shifted the focus onto new molecules like Relebactam. Accurate tracking of density, solubility, and impurity content can make or break a batch destined for pharmaceutical final dosage forms. Regulatory agencies—for instance, the FDA, EMA, and national bodies—scrutinize not only the active pharmaceutical ingredient but any trace contaminants, given the growing risk of hypersensitivity reactions and downstream toxicity. Adopting real-time digital tracking and extensive batch monitoring across supply chain points could help eliminate cross-contamination or mislabeling. Investment in improved analytical instrumentation and third-party validation keeps the supply chain honest and safe, especially as demand rises internationally.
Professional experience in pharma production teaches the value of transparent sourcing, close coordination with upstream suppliers, and relentless attention to laboratory verification. Rather than focus solely on finished product performance, the best outcomes arise from deep respect for handling the starting raw material. Strong supplier audits, robust documentation, and adoption of hazard mitigation protocols keep risks low and product performance reliable. Taking the time to thoroughly review each batch, verify not only the obvious metrics—density, appearance, solubility—but also the secondary ones, like potential allergen presence or heavy metal content, heads off problems at the root.
Anyone who's spent time on a pharmaceutical production floor knows the constant vigilance required when dealing with potent chemical powders. Personal safety gear becomes second nature, and routine surface cleaning ensures that accidental mix-ups or dust accumulations do not happen. Good warehouse design—such as segregated storage, clear labeling by HS Code and batch, and temperature controls—supports these efforts. All incoming Relebactam gets sampled for rapid screening, with broad chemical and microbial testing to flag non-conformance as early as possible. Communication with regulatory auditors and on-site quality supervisors makes all the difference in maintaining uninterrupted supply and avoiding expensive recalls due to minor lapses.
Over years of hands-on work with numerous pharmaceutical agents, including Relebactam and kindred substances, a few lessons stand out. Advances in automated weighing, closed-transfer powder handling, and digital tracking shrink the risk of exposure both to humans and to the active ingredient itself. Sophisticated software platforms now provide real-time visibility into both physical agent movement and specification matching, allowing teams to spot and correct deviations before they propagate. These improvements, coupled with traditional focus on cleanliness, transparency, and careful study of the material’s fundamental properties (density, morphology, chemical reactivity), result in safer, more reliable pharmaceutical products, with fewer recalls or downstream health concerns for patients and manufacturing staff alike.
Chengguan District, Lanzhou, Gansu, China
