Description

Avibactam Impurity CAS NO 2064219-26-5 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the β-lactamase inhibitor Avibactam during its development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and contract research organizations (CROs) for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Avibactam Active Pharmaceutical Ingredient (API) batches.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels in compliance with ICH Q3A/B guidelines.
• Quality Control & Assurance: Employed in routine QC testing to ensure Avibactam drug substance and drug products meet stringent purity specifications.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, humidity, light) as part of pharmaceutical stability testing programs.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough understanding and control of the impurity profile.
• Research & Development: Facilitates chemical and metabolic pathway studies related to Avibactam, aiding in the understanding of degradation mechanisms.

Basic Information

Product Name	Avibactam Impurity
CAS No.	2064219-26-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Avibactam Related Compound; Avibactam Process Impurity; NXL-104 Impurity; AVIBASTAT Impurity; (2S,5R)-7-oxo-6-(sulfoxy)-1,6-diazabicyclo[3.2.1]octane-2-carboxamide derivative; β-Lactamase Inhibitor Impurity; Diazabicyclooctane Sulfonate Impurity
EINECS	Contact for details

Quality Control

Our Avibactam Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing batch-specific results against established specifications. Our quality commitment aligns with cGMP principles for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity. Avoid repeated or prolonged exposure to the atmosphere.

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%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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