Description

Avibactam Impurity 3(2R,5S) is a defined stereoisomeric impurity of the β-lactamase inhibitor Avibactam. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require precise characterization of impurities to ensure drug safety and meet stringent regulatory requirements for antibiotic production.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Avibactam active pharmaceutical ingredient (API) and its formulations.
• Analytical Method Development: Used to develop and validate sensitive HPLC, UPLC, or LC-MS methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to ensure the specificity and accuracy of impurity assays for Avibactam batches.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor the formation and levels of this specific impurity over time.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the fate of this impurity and its potential impact.

Basic Information

Product Name	Avibactam Impurity 3(2R,5S)
CAS No.	1383814-68-3
Molecular Formula	C7H11N3O5S
Molecular Weight	249.25 g/mol
Synonyms	(2R,5S)-2-Carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl hydrogen sulfate; NXL-104 Impurity 3; AVI-IMP-03; Avibactam Stereoisomer Impurity; (2R,5S)-Avibactam Related Compound; 1,6-Diazabicyclo[3.2.1]octan-7-one, 2-(aminocarbonyl)-6-(sulfooxy)-, (2R,5S)-; Avibactam EP Impurity C (stereoisomer)
EINECS	Contact for details

Quality Control

Every batch of Avibactam Impurity 3(2R,5S) is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and stability. Our quality system is designed to meet the exacting standards of pharmaceutical reference material users. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing results from tests including identification (IR, NMR), assay (HPLC), chiral purity, and related substances. We support compliance with ICH, USP, and EP guidelines.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Assay (HPLC)	≥ 98.0%
Chiral Purity (Chiral HPLC)	≥ 99.0% (2R,5S)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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