Description

Avibactam Impurity 6 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the β-lactamase inhibitor, Avibactam. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during analytical testing. It is an essential material for research laboratories, quality assurance departments, and manufacturers engaged in the synthesis and purification of Avibactam and its related pharmaceutical formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, LC-MS, and other chromatographic methods in Avibactam API quality control.
• Analytical Method Development & Validation: Critical for developing, validating, and transferring analytical procedures to monitor and control impurity profiles.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used to track the formation and levels of this specific impurity under various stress conditions and throughout shelf-life studies.
• Process Chemistry Research: Aids in understanding and optimizing the Avibactam synthesis pathway to minimize the formation of this impurity.
• Pharmacopoeial Testing: Serves as a reference material for testing against pharmacopoeial monographs (e.g., USP, EP) where impurity specifications are defined.

Basic Information

Product Name	Avibactam Impurity 6
CAS No.	2064219-23-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(2S,5R)-7-Oxo-1,6-diazabicyclo[3.2.1]octane-2-carboxylic acid impurity; Avibactam Related Compound 6; NXL-104 Impurity 6; AVI Impurity 6; β-lactamase inhibitor impurity; Diazabicyclooctane derivative impurity
EINECS	Contact for details

Quality Control

Every batch of Avibactam Impurity 6 is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including advanced chromatographic and spectroscopic techniques, to confirm identity, purity, and impurity profile. A Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality standards are designed to meet the rigorous demands of pharmaceutical reference material applications.

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 Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider conditions recommended for sensitive organic compounds.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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