Avibactam Sodium For Human Medicine

Avibactam Sodium is a β-lactamase inhibitor API used in early-stage antibacterial formulation development, where material consistency and impurity control are critical.

Material Context

In contemporary antibacterial formulation development, Avibactam Sodium is typically introduced at an early R&D stage, where material stability, impurity control, and batch-to-batch consistency are critical for downstream formulation success. This API is positioned to support that phase of development by offering predictable and reproducible performance, enabling formulation teams to focus on optimization rather than compensating for material variability.

Rather than emphasizing marketing claims, the material is supplied with clearly defined analytical specifications, making it suitable for research, pilot studies, and scale-up activities that require reliable and repeatable results.

Technical Profile

• Product Name: Avibactam Sodium API
• CAS Number: 1192491-59-1
• Chemical Form: Sodium salt
• Appearance: White to off-white solid powder
• Assay / Purity: ≥ 98% (HPLC)
• Solubility: Freely soluble in water; compatible with standard formulation solvents
• Storage Recommendations:

1. -Short-term: 2–8 °C, tightly sealed
2. -Long-term: −20 °C preferred
3. -Protect from moisture and direct light

All parameters are verified on a per-batch basis and documented in the accompanying Certificate of Analysis (CoA).

Application Perspective

From a formulation standpoint, Avibactam Sodium is primarily assessed for compatibility in β-lactam antibiotic combinations. Early-stage evaluation typically focuses on:

• Dissolution behavior
• pH sensitivity
• Impurity evolution under stress conditions

Accordingly, this material is prepared with controlled impurity profiles suitable for comparative studies, analytical method development, and formulation feasibility assessments, rather than one-off laboratory experiments.

Documentation & Compliance Support

Each shipment includes a documentation package commonly required for internal audits and regulatory preparation, including:

• Batch-specific Certificate of Analysis (CoA)
• MSDS / TDS
• Impurity profile summary
• Basic stability reference data

Documentation is structured to integrate smoothly into CMC files and internal quality systems, reducing follow-up queries during technical and regulatory review.

Packaging, Handling & Logistics

To maintain material integrity during storage and transport:

• Moisture-resistant primary containers with secure sealing
• Desiccant inclusion for extended transit periods
• Clear batch and lot identification to support full traceability

Packaging formats can be adapted for sample quantities used in formulation trials or bulk supply aligned with manufacturing schedules.

Supply Model

Most customers adopt a staged procurement strategy:

• Initial sample orders for analytical verification and formulation screening
• Internal qualification based on impurity and stability performance
• Transition to regular bulk supply once specifications are finalized

This approach reduces development risk while ensuring long-term supply continuity.

FAQs

Q: Is this material supplied as a finished pharmaceutical product?

A: No. Avibactam Sodium is supplied strictly as an API for formulation and manufacturing use.

Q: Can the API support regulatory submissions?

A: Yes. The provided documentation supports internal CMC preparation and technical review stages.

Q: What is the typical minimum order quantity?

A: Pilot-scale quantities are available for sampling, with scalable volumes for long-term supply.

Q: How should opened containers be handled?

A: Reseal promptly after opening and store under recommended conditions to minimize moisture exposure.