Description

Avibactam Sodium Impurity is a high-purity reference standard used in the analytical characterization and quality control of the β-lactamase inhibitor, Avibactam Sodium. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product purity, identify potential contaminants, and meet stringent regulatory requirements for drug development. It is essential for applications in pharmaceutical R&D, quality assurance, and the production of generic and novel antibacterial drug formulations.

Application

• Pharmaceutical Reference Standard for analytical method development and validation.
• Impurity profiling and identification in Avibactam Sodium Active Pharmaceutical Ingredient (API).
• Quality control testing to monitor and quantify specified impurities during manufacturing.
• Stability studies to assess degradation pathways of Avibactam Sodium formulations.
• Research and development of new β-lactam/β-lactamase inhibitor combinations.
• Calibration standard for chromatographic systems (e.g., HPLC, UPLC).
• Regulatory compliance and submission support for drug master files (DMFs).

Basic Information

Product Name	Avibactam Sodium Impurity
CAS No.	1416134-73-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Avibactam Related Compound; Avibactam Sodium Specified Impurity; (2S,5R)-7-oxo-2-[(sulfooxy)amino]-1,6-diazabicyclo[3.2.1]octane-6-carboxylate Impurity; NXL-104 Impurity; AVIBASTAT Impurity; β-Lactamase Inhibitor Impurity; 1,6-Diazabicyclo[3.2.1]octane Derivative Impurity
EINECS	Contact for details

Quality Control

Our Avibactam Sodium Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with every shipment to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.