Description

Avibactam Impurity 44 is a designated impurity of the β-lactamase inhibitor Avibactam, a critical component in novel antibiotic combinations. This reference standard is essential for pharmaceutical research and development, enabling the identification, quantification, and control of this specific impurity during drug substance manufacturing. It is primarily used by analytical laboratories and quality control units within the pharmaceutical industry to ensure the purity, safety, and regulatory compliance of Avibactam-based drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the precise quantification of Avibactam Impurity 44 in Avibactam active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles throughout the drug lifecycle.
• Quality Control & Batch Release: Used in routine QC testing to ensure that impurity levels in commercial batches comply with strict International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity acceptance criteria and justify specification limits.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Avibactam synthesis pathway to minimize the formation of this impurity.

Basic Information

Item	Detail
Product Name	Avibactam Impurity 44
CAS No.	2064219-22-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Avibactam Related Compound 44; NXL-104 Impurity 44; (2S,5R)-7-oxo-2-[(sulfooxy)amino]-1,6-diazabicyclo[3.2.1]octane-6-carboxylate Impurity; AVI Impurity 44; β-Lactamase Inhibitor Impurity; Diazabicyclooctane Sulfate Impurity
EINECS	Contact for details

Quality Control

Every batch of Avibactam Impurity 44 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with specified purity criteria.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
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.