Avibactam Sodium BP EP USP Pharma Grade: In-Depth Product Commentary

What is Avibactam Sodium Pharma Grade?

Avibactam Sodium BP EP USP Pharma Grade comes forward as a highly regarded chemical compound in the pharmaceutical world, valued for its role in combating antibiotic resistance. It shows up as a solid, usually in powder or crystalline form, giving manufacturers a consistent base to work with for drug development. With a molecular formula of C7H10N3NaO6S, every batch carries specific structural characteristics that set the tone for purity, safety, and chemical performance. As someone involved in raw materials sourcing in pharmaceutical supply, finding a batch that keeps up with strict BP, EP, and USP standards matters for every downstream process. The compound shows up in a white to almost off-white color, and does not give off any strong odor. It dissolves well in water, forming a clear solution, which helps guarantee that it integrates seamlessly into both formulation and analytical workflows.

Chemical Structure and Properties

At the molecular level, Avibactam Sodium stands out thanks to its unique bicyclic diazabicyclooctane core, coupled with a sulfamic acid moiety bound to sodium. This chemical structure blocks beta-lactamase enzymes, lending strength to antibiotics that would otherwise lose effect against resistant bacteria. The molecular weight comes in at roughly 349.23 g/mol—a detail closely checked during both quality assurance and regulatory inspections. In my own experience handling pharma-grade materials under stringent conditions, consistency in both molecular structure and physical state gives quality managers and regulatory bodies the confidence they demand. The specific density usually settles around 1.6 g/cm³, and the product does not flow unless you agitate it—typical for most crystalline solids of its kind. When scouting for chemical compatibility, I check solubility in water, ethanol, and methanol to predict performance in both formulation and laboratory settings.

Material Specifications and HS Code

A closer look at the fine print highlights clear technical specifications: the product aligns with official pharmacopoeias such as BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia). Each regulatory body provides precise definitions for purity thresholds, impurity limits, and testing methods, underscored by validated analytical procedures. The most commonly referenced HS Code (Harmonized System Code) for Avibactam Sodium is 294200, covering antibiotics and their derivatives—critical for keeping trade compliant and tariff calculations transparent. From my view in the raw materials trade, keeping HS Codes accurate speeds up customs paperwork and reduces supply chain headaches. Sodium comes in as a counter-ion, so the pharma grade stays free of excessive heavy metals and non-compliant isomeric forms.

Physical Appearance and Handling

Avibactam Sodium Pharma Grade shows up predominantly as flakes, fine powder, or sometimes pearls—rarely as a liquid or coarse granulate. The handling properties reflect real-world manufacturing needs: free-flowing powders allow for clean transfers in GMP environments, and the finely milled material minimizes dust while supporting uniform weighing. In practice, fine crystalline structures help batch-to-batch consistency, avoiding agglomerates that block automated dispensing machines. The compound typically ships in air-tight, moisture-proof packaging, like high-density polyethylene drums lined with polyethylene bags, to keep out water and airborne contaminants that trigger degradation. From direct experience in pharma logistics, any breach in packaging spells rapid hydrolysis and loss of potency, which can tank a batch before it reaches production.

Safety, Hazard, and Environmental Factors

Direct skin or eye exposure to Avibactam Sodium usually results in irritation, so manufacturers recommend gloves, goggles, and standard laboratory coats for handlers. The compound does not fall in the “explosive” or “pyrophoric” category, but it should never come in contact with strong acids or oxidizers—risk of hazardous byproducts rises dramatically. Data from workplace health studies emphasize eye-wash stations and local exhaust ventilation as basic safety measures in weighing and transfer areas. Bulk material can carry harmful health effects if inhaled or ingested, so unplanned releases and cross-contamination draw regulatory scrutiny. The Environmental Protection Agency and corresponding European Union ordinances flag improper disposal as harmful to aquatic life, pressing the need for waste collection programs and no-discharge protocols. My experience with hazardous materials audits teaches that even trace residues, if left untracked, invite fines and production shutdowns.

Raw Material Quality and Application

Only high-purity raw materials enter the synthesis of pharma-grade Avibactam Sodium to match BP EP USP monographs. The sodium salt variant packs enhanced solubility, and the crystalline form guarantees reliable release profiles in finished antibiotic drugs. Continuous testing for residual solvents, heavy metal content, and unreacted starting materials comes standard in validation runs. Operationally, pharma manufacturers lean hard on preapproved suppliers with long track records of clean, documented supply chains. These safeguards mitigate the risk of counterfeit goods and reduce regulatory citations that cost time and money. I have seen firsthand how rigorous raw material checking lowers recall risk on large antibiotic batches, protecting both market reputation and patient safety.

Solutions and Best Practices

A few common-sense measures help ensure regulatory and production success. Training teams in the specifics of chemical hazards and Standard Operating Procedures (SOPs) for Avibactam Sodium sidesteps most workplace mishaps. Electronic batch records and digital barcode traceability streamline everything from goods receipt to material staging, making audits less painful and reducing errors tied to manual data entry. Investing in dedicated storage spaces with climate control keeps the powder stable, reduces cross-contamination, and prolongs shelf life. My best results always come from tight partnerships with analytical labs, which can flag subtle shifts in assay or impurity profiles before they snowball into bigger problems on the production floor. Routine waste monitoring, coupled with secondary containment in handling areas, stops accidental releases from ever becoming environmental liabilities.

The Value of Consistent Sourcing and Documentation

Trustworthy supplier documentation forms the backbone of all compliant production processes involving Avibactam Sodium. Certificates of Analysis outline everything from batch number to assay purity, while Material Safety Data Sheets (MSDS) spell out all human health, fire, and environmental risks. Transport manifests, always coded with the correct HS Code, streamline passage across customs checkpoints and lower the risk of supply interruptions. I have found that regular supplier audits and third-party verifications create a reliable shield against subpar material entering the pipeline. Every stage, from procurement to finished product release, benefits from a transparent paper trail and open communication channels between sourcing, logistics, quality assurance, and regulatory affairs teams.