Description

Avibactam Impurity 12 Tetrabutylammonium Salt is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for quality control and regulatory compliance in the development and manufacturing of the β-lactamase inhibitor, Avibactam. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and manufacturers of active pharmaceutical ingredients (APIs) to ensure product purity and safety.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Avibactam API and its formulations.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, or LC-MS methods in pharmaceutical analysis.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and compliance check to meet pharmacopeial standards (e.g., USP, EP, ICH Q3A/B) for impurity profiling.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation in Avibactam drug substances and products.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research & Development: Used in synthetic chemistry and metabolic studies to understand the degradation pathways and chemistry of Avibactam.

Basic Information

Product Name	Avibactam Impurity 12 Tetrabutylammonium Salt
CAS No.	1383814-75-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(2S,5R)-7-Oxo-2-(sulfooxy)-1,6-diazabicyclo[3.2.1]octan-6-yl Hydrogen Sulfate Tetrabutylammonium Salt; Avibactam Sulfate Dimer Tetrabutylammonium Salt; NXL-104 Impurity 12 TBA Salt; AVI-IMP-12 TBA Salt; (2S,5R)-7-Oxo-2-[(sulfooxy)imino]-1,6-diazabicyclo[3.2.1]octan-6-yl Hydrogen Sulfate Tetrabutylammonium Salt; Tetrabutylammonium (2S,5R)-7-Oxo-2-(sulfooxy)-1,6-diazabicyclo[3.2.1]octan-6-yl Sulfate
EINECS	Contact for details

Quality Control

Our Avibactam Impurity 12 Tetrabutylammonium Salt is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure compliance with high-grade reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. 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
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH limits

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