Avibactam Sodium API
Product Context for Development & Sourcing Teams
In modern antibacterial formulation projects, selecting a β-lactamase inhibitor intermediate is rarely driven by availability alone. For many development teams, the decision to introduce Avibactam Sodium API into a formulation pipeline depends on analytical reproducibility, storage stability, and supplier execution capability, not marketing claims.
This page focuses on how the material is typically evaluated, handled, and qualified during early development and subsequent scale-up, providing practical information relevant to R&D, QA, and procurement departments.
Material Identification & Core Properties
- ▸ Product Name: Avibactam Sodium API
- ▸ CAS No.: 1192491-61-4
- ▸ Molecular Form: Sodium salt
- ▸ Appearance: White to off-white crystalline or amorphous powder
- ▸ Assay (HPLC): ≥98%
- ▸ Intended Use: Pharmaceutical raw material for human drug development
Each batch is released only after internal review of assay values and impurity distribution, ensuring lot-to-lot consistency suitable for comparative analytical work.
How Laboratories Typically Qualify This API
Analytical Verification
During incoming material qualification, laboratories usually focus on:
- ▸ Assay repeatability against in-house reference standards
- ▸ Retention time alignment in HPLC or LC-MS methods
- ▸ Presence and control of low-level related substances
This data-driven review allows QC teams to quickly determine whether the material can be integrated into existing analytical systems without method redevelopment.
Solubility & Handling Behavior
Instead of relying on generic solubility descriptions, formulation scientists often confirm:
- ▸ Dissolution behavior in aqueous and buffered systems
- ▸ Sensitivity to moisture during weighing and transfer
- ▸ Filtration behavior in small-volume solution preparation
For this reason, sample orders are commonly used to conduct hands-on evaluation before moving to larger procurement volumes.
Stability Considerations
As with many small-molecule APIs, environmental exposure directly impacts material performance. Based on stability observations:
- ▸ Short-term storage at 2–8 °C is acceptable for routine laboratory use
- ▸ Long-term storage at −20 °C is recommended to minimize degradation
- ▸ Protection from humidity and light is required during handling
These guidelines help teams design compliant storage and usage protocols early in development.
Documentation & Traceability
Each delivery of Avibactam Sodium API is accompanied by a complete documentation set, including:
- ▸ Certificate of Analysis (COA) with numerical assay results
- ▸ MSDS for safe handling and transport
- ▸ Technical Data Sheet (TDS) outlining storage and handling guidance
- ▸ Batch and lot traceability for internal quality systems
Additional analytical or stability data can be provided to support internal audits or regulatory preparation.
Packaging & Supply Execution
Sealed, moisture-protected containers.
Batch number, net weight, and identification clearly indicated.
Temperature-controlled shipping available when required.
Once technical qualification is completed, the material can be supplied under defined delivery schedules as part of a stable bulk supply arrangement.
Typical Procurement Flow
Placement of sample orders for analytical and formulation testing.
QA and R&D confirmation based on COA and performance data.
Transition to routine or project-based bulk supply with agreed specifications.
This phased approach reduces technical risk and aligns procurement with development milestones.
Common Technical Questions
Q: Is this material supplied as a finished drug product?
A: No. Avibactam Sodium API is provided exclusively as a pharmaceutical raw material.
Q: Can this API be used for early-stage formulation trials?
A: Yes. Many teams begin with small-scale evaluations before committing to larger volumes.
Q: How should unused material be handled?
A: Reseal promptly after use, minimize exposure to ambient air, and return to controlled storage conditions.
Q: Is batch-specific documentation included?
A: Yes. Each batch is supplied with its own COA and traceability information.
Ready to Source Avibactam Sodium API?
We supply pharmaceutical-grade Avibactam Sodium API with full documentation, batch traceability, and flexible supply arrangements tailored to your development timeline.
Contact our team to discuss how Avibactam Sodium API fits into your next formulation project.
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