Description

Avibactam Impurity 10 is a designated reference standard used for the analytical profiling and quality control of the β-lactamase inhibitor, Avibactam. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure the purity, safety, and efficacy of the final drug substance. It is primarily utilized in the development and validation of chromatographic methods for impurity identification and quantification, supporting compliance with stringent regulatory requirements.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Avibactam drug substance and formulations.
• Method Development & Validation: Essential for developing, validating, and transferring HPLC/UPLC methods in analytical R&D and quality control laboratories.
• Stability Studies: Used to monitor the formation of this specific degradation product during forced degradation and long-term stability testing of Avibactam.
• Regulatory Compliance & Filing: Provides necessary data for regulatory submissions (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Process Chemistry Optimization: Helps identify and control the formation of this impurity during the synthesis and purification stages of Avibactam manufacturing.
• Quality Assurance/Quality Control (QA/QC): Used for routine batch release testing to ensure Avibactam products meet predefined purity specifications.

Basic Information

Product Name	Avibactam Impurity 10
CAS No.	1383814-64-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	NXL-104 Impurity 10; AVI-IMP-10; (2S,5R)-7-oxo-2-(sulfooxy)-1,6-diazabicyclo[3.2.1]octane-6-sulfonate Impurity; Avibactam Related Compound 10; β-lactamase inhibitor impurity; Azabicyclooctane sulfonate impurity
EINECS	Contact for details

Quality Control

Our Avibactam Impurity 10 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assay and identity confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, identity, and other critical parameters.

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 under dry conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% 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.