Description

Avibactam Impurity 45 is a designated process-related impurity of the β-lactamase inhibitor, Avibactam. This compound is critical for pharmaceutical research and development, specifically for method development, validation, and quality control of the active pharmaceutical ingredient (API). It is primarily required by analytical laboratories, quality assurance departments, and regulatory affairs teams within the pharmaceutical and biotechnology industries to ensure product purity and compliance with stringent regulatory standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Avibactam Impurity 45 in Avibactam API and its formulations.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods for impurity profiling.
• Quality Control & Batch Release: Serves as a system suitability standard in routine QC testing to monitor impurity levels against established specifications.
• Stability Studies: Employed in forced degradation and long-term stability studies to track impurity formation and degradation pathways.
• Regulatory Submissions: Provides necessary impurity data for regulatory filings (e.g., ANDA, NDA, CTA) to agencies like the US FDA and EMA.
• Process Chemistry Research: Used to study and optimize synthesis and purification processes to minimize this specific impurity.

Basic Information

Product Name	Avibactam Impurity 45
CAS No.	2064219-20-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	NXL-104 Impurity 45; AVI-IMP-45; (2S,5R)-7-oxo-2-[(sulfooxy)amino]-1,6-diazabicyclo[3.2.1]octane-6-sulfonic acid impurity; Avibactam Related Compound 45; β-Lactamase Inhibitor Impurity 45; Avibactam Sulfate Ester Impurity; Process Impurity of Avibactam
EINECS	Contact for details

Quality Control

Our Avibactam Impurity 45 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical impurity standards. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C. Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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