Description

Avibactam Impurity 28 is a designated reference standard used in the analytical profiling and quality control of the β-lactamase inhibitor, Avibactam. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily utilized for method development, validation, and routine testing in the production of novel antibiotic combinations.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Avibactam active pharmaceutical ingredient (API) and related drug formulations.
• Analytical Method Development: Used in developing and validating High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC) methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for batch release testing to monitor and control impurity levels in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed as a marker to track degradation pathways and establish the shelf-life of Avibactam-containing drug products.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development (R&D): Used in synthetic chemistry research to understand and mitigate the formation of this specific impurity during the manufacturing process.

Basic Information

Product Name	Avibactam Impurity 28
CAS No.	2064219-14-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(2S,5R)-7-Oxo-2-(sulfooxy)-1,6-diazabicyclo[3.2.1]octan-6-yl Hydrogen Sulfate (Impurity of Avibactam); Avibactam Related Compound 28; NXL-104 Impurity 28; AVI-IMP-28; (2S,5R)-1,6-Diazabicyclo[3.2.1]octan-7-one 2,6-bis(hydrogen sulfate); Avibactam Disulfate Impurity
EINECS	Contact for details

Quality Control

Our Avibactam Impurity 28 is manufactured under strict quality systems. Each batch is characterized and tested using advanced analytical techniques, including HPLC and mass spectrometry, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile. 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. Keep the container tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Water Content (KF)	≤ 5.0%

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