Description

Avibactam Impurity D CAS NO 2085372-13-8 is a high-purity reference standard used for the analytical profiling and quality control of the β-lactamase inhibitor, Avibactam. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is an essential material for method development, validation, and stability studies in the production of novel antibacterial combination therapies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, LC-MS, and other chromatographic analyses.
• Quality Control & Assurance: Critical for establishing impurity profiles and setting specifications in Avibactam Active Pharmaceutical Ingredient (API) manufacturing.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity data.
• Research & Development: Used in stability studies, degradation pathway elucidation, and process chemistry optimization.
• Method Development & Validation: Serves as a key component in developing and validating analytical methods for impurity detection and quantification.

Basic Information

Product Name	Avibactam Impurity D
CAS No.	2085372-13-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(2S,5R)-7-Oxo-1,6-diazabicyclo[3.2.1]octane-2-carboxamide; Avibactam Related Compound D; NXL-104 Impurity D; AVIBASTAT Impurity D; (1R,2S,5R)-7-Oxo-1,6-diazabicyclo[3.2.1]octane-2-carboxamide; Diazabicyclooctanone Impurity D
EINECS	Contact for details

Quality Control

Every batch of Avibactam Impurity D is produced and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH guidelines

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