Description

Avibactam Impurity 28 is a high-purity chemical reference standard used in the analytical profiling and quality control of the β-lactamase inhibitor, Avibactam. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized by professionals in pharmaceutical development, quality assurance, and analytical chemistry for method validation and impurity identification.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Avibactam Active Pharmaceutical Ingredient (API) batches.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control & Assurance (QC/QA): Essential for routine quality control testing to monitor impurity levels and ensure API purity meets stringent pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed in forced degradation and long-term stability studies of Avibactam to understand degradation pathways and establish shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Used in synthetic chemistry R&D to study the formation and fate of process-related impurities during Avibactam synthesis.

Basic Information

Product Name	Avibactam Impurity 28
CAS No.	1383814-70-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	NXL-104 Impurity 28; (2S,5R)-7-oxo-2-[(sulfooxy)methyl]-1,6-diazabicyclo[3.2.1]octan-6-yl hydrogen sulfate (Impurity of Avibactam); AVI Impurity 28; Avibactam Related Compound 28; UNII-9M3Z84C6VJ (component); Diazabicyclooctane sulfonate impurity
EINECS	Contact for details

Quality Control

Our Avibactam Impurity 28 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality standards align with ICH guidelines to support your regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
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%
Residue on Ignition	≤ 0.5%

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