Description

Avibactam Impurity 13 is a designated impurity of the novel β-lactamase inhibitor, Avibactam. This compound is critical for pharmaceutical research and development, specifically for method development, validation, and quality control of Avibactam active pharmaceutical ingredients (APIs) and finished drug products. It is an essential reference standard for analytical laboratories in the pharmaceutical and biotechnology sectors, ensuring the purity, safety, and efficacy of antibiotic formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Avibactam API.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Regulatory Compliance & Filings: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing impurity profile data.
• Stability Studies: Used to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of drug products.
• Process Chemistry R&D: Aids in the optimization of Avibactam synthesis and purification processes by tracking this impurity.
• Quality Assurance/Control (QA/QC): Serves as a system suitability standard and for routine batch release testing in GMP environments.

Basic Information

Product Name	Avibactam Impurity 13
CAS No.	2064219-24-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Avibactam Related Compound 13; NXL-104 Impurity 13; (2S,5R)-7-Oxo-1,6-diazabicyclo[3.2.1]octane-2-carboxamide Impurity; AVI Impurity 13; β-Lactamase Inhibitor Impurity; Avibactam Process Impurity; Avibactam Degradant
EINECS	Contact for details

Quality Control

Every batch of Avibactam Impurity 13 is manufactured and handled under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and research needs.

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 (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
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.