Description

Avibactam Impurity 4 is a specified impurity of the β-lactamase inhibitor, Avibactam, used in pharmaceutical quality control and research. This compound is critical for the development and validation of analytical methods to ensure the purity and safety of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the synthesis, quality assurance, and regulatory compliance of β-lactam combination drugs.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Avibactam Impurity 4 in Avibactam API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to monitor batch-to-batch consistency and ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, humidity, light) as per ICH stability protocols.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Process Chemistry Research: Used by R&D scientists to study and optimize the Avibactam synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Avibactam Impurity 4
CAS No.	2064219-25-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	NXL-104 Impurity 4; AVI-IMP-4; (2S,5R)-7-oxo-2-[(sulfooxy)amino]-1,6-diazabicyclo[3.2.1]octane-6-carboxylate Impurity 4; Avibactam Related Compound 4; β-lactamase inhibitor impurity; Diazabicyclooctane sulfonate impurity; Pharmaceutical impurity standard 2064219-25-4
EINECS	Contact for details

Quality Control

Our Avibactam Impurity 4 is manufactured under strict quality systems suitable for pharmaceutical reference standards. Each batch undergoes rigorous analytical testing, including HPLC purity assay, residual solvent analysis, and structural confirmation (e.g., by NMR and MS) to ensure identity, purity, and traceability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and methods in compliance with current industry 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 dry conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.