Description

Avibactam Impurity 29 is a specified impurity of the β-lactamase inhibitor, Avibactam. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development and quality control. It is primarily used by researchers and quality assurance professionals in the pharmaceutical industry to ensure the purity, safety, and efficacy of Avibactam-based drug substances and products.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of impurities in Avibactam API.
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) in pharmaceutical R&D laboratories.
• Critical component in stability studies and impurity profiling to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Used in quality control (QC) testing to establish specification limits for drug substance and drug product release.
• Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data.
• Valuable for pharmacopoeial testing and compliance with standards from USP, EP, or other pharmacopoeias.

Basic Information

Product Name	Avibactam Impurity 29
CAS No.	2064219-15-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	NXL-104 Impurity 29; AVI-IMP-29; Avibactam Related Compound 29; (2S,5R)-7-oxo-6-(sulfooxy)-1,6-diazabicyclo[3.2.1]octane-2-carboxamide Impurity; β-Lactamase Inhibitor Impurity; Diazabicyclooctane Sulfate Ester Impurity
EINECS	Contact for details

Quality Control

Our Avibactam Impurity 29 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and structural confirmation (e.g., by NMR and MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with every shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles for pharmaceutical impurities.

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 dry, inert conditions to maintain stability and purity. The container should be stored in a desiccator or under an inert atmosphere after opening.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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