Description

Avibactam Impurity 27 is a designated process-related impurity associated with the synthesis of the β-lactamase inhibitor, Avibactam. This high-purity reference standard is critical for pharmaceutical research and development, specifically for method development, validation, and quality control of the active pharmaceutical ingredient (API). It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable, well-characterized impurities to ensure product safety, regulatory compliance, and batch-to-batch consistency.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Avibactam Impurity 27 in Avibactam API and its formulations.
• Analytical Method Development & Validation: Critical for developing and validating sensitive and specific analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines and regulatory filings.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions and throughout the drug product's shelf life.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Avibactam by identifying and controlling the formation of this impurity.
• Regulatory Submissions: Provides essential data for regulatory documentation (e.g., CMC sections of IND/NDA/ANDA) to demonstrate thorough impurity characterization and control strategies.

Basic Information

Product Name	Avibactam Impurity 27
CAS No.	2064219-16-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Avibactam Related Compound 27; (2S,5R)-7-Oxo-6-(sulfoxy)-1,6-diazabicyclo[3.2.1]octane-2-carboxamide Impurity 27; NXL-104 Impurity 27; AVI-IMP-27; Process Impurity of Avibactam; Avibactam EP Impurity C; Avibactam USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Avibactam Impurity 27 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure they meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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