Description

Avibactam Impurity 46 is a specified impurity associated with the β-lactamase inhibitor, Avibactam. This compound is critical for pharmaceutical research and development, particularly in the analytical characterization and quality control of Avibactam and its drug products. It serves as a key reference standard for method development, validation, and regulatory compliance in the pharmaceutical industry. Researchers and quality control laboratories in the global pharmaceutical and fine chemical sectors require this high-purity impurity to ensure the safety and efficacy of their products.

Application

• Primary use as a certified reference standard for the analysis of Avibactam drug substance and drug products.
• Critical for analytical method development and validation (HPLC, LC-MS) in pharmaceutical R&D.
• Essential for impurity profiling and identification studies to meet ICH guidelines.
• Used in stability studies to monitor degradation pathways of Avibactam.
• Supports regulatory submissions (e.g., for FDA, EMA) by providing impurity data.
• Employed in quality control laboratories for routine batch release testing.
• Valuable for pharmacological and toxicological studies of impurity behavior.

Basic Information

Item	Detail
Product Name	Avibactam Impurity 46
CAS No.	1804915-68-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Avibactam Related Compound 46; (2S,5R)-7-Oxo-1,6-diazabicyclo[3.2.1]octane-2-carboxamide, 6-(Sulfooxy)-; NXL-104 Impurity 46; AVI-IMP-46; Avibactam Sulfate Ester Impurity; β-Lactamase Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Avibactam Impurity 46 is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request, providing detailed results for identity, purity, and related substances as determined by validated chromatographic methods (e.g., HPLC). We adhere to cGMP principles for the production of pharmaceutical reference standards.

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 material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. Ensure the container is sealed tightly after each use to prevent moisture absorption.

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)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%

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