Description

Avibactam Impurity 39 is a designated process-related impurity and reference standard used in the analytical profiling of the β-lactamase inhibitor, Avibactam. This compound is critical for pharmaceutical research and development, specifically for method validation, stability studies, and ensuring the purity and safety of the final Active Pharmaceutical Ingredient (API). It is an essential material for quality control laboratories, analytical chemists, and regulatory affairs professionals within the global pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of this specific impurity in Avibactam API and its formulations.
• Analytical Method Development and Validation (HPLC/LC-MS): Critical for developing, optimizing, and validating chromatographic methods to monitor impurity profiles during manufacturing.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to track the formation of this impurity under various stress conditions.
• Quality Control and Batch Release: Serves as a system suitability standard and for setting specification limits in the quality control testing of Avibactam batches.
• Regulatory Compliance and Filing: Provides essential data for regulatory submissions (e.g., to FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Avibactam to minimize the formation of this impurity.

Basic Information

Item	Details
Product Name	Avibactam Impurity 39
CAS No.	2089462-91-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	NXL-104 Impurity 39; AVI-IMP-39; Avibactam Related Compound 39; (2S,5R)-7-oxo-2-[(sulfooxy)amino]-1,6-diazabicyclo[3.2.1]octane-6-carboxylic acid impurity; AVI Process Impurity 39; β-lactamase inhibitor impurity; Avibactam sulfamate impurity
EINECS	Contact for details

Quality Control

Every batch of Avibactam Impurity 39 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing, including HPLC purity analysis, spectroscopic identification (NMR, MS), and determination of residual solvents and moisture content to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with each shipment.

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.

Specification

Item	Specification
Appearance	White to off-white solid
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% w/w

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