Description

Avibactam Impurity CAS NO 1797133-98-2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the β-lactamase inhibitor, Avibactam. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require reliable impurity standards to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Avibactam active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation and levels of this impurity during forced degradation and long-term stability testing of Avibactam formulations.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Chemical Research & Synthesis: Acts as a key intermediate or reference compound in synthetic chemistry research aimed at understanding Avibactam's degradation pathways or synthesizing novel analogs.
• Quality Assurance/Quality Control (QA/QC): Integral for in-process testing and final release testing to ensure Avibactam batches meet stringent purity specifications.

Basic Information

Product Name	Avibactam Impurity
CAS No.	1797133-98-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Avibactam Related Compound; Avibactam Process Impurity; NXL-104 Impurity; AVIBASTAT Impurity; (2S,5R)-7-oxo-2-(sulfooxy)-1,6-diazabicyclo[3.2.1]octan-6-yl hydrogen sulfate (specific isomer designation may vary); β-lactamase inhibitor impurity; Avibactam Degradant
EINECS	Contact for details

Quality Control

Our Avibactam Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and research requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (typically 15-25°C). The product is light-sensitive and should be handled and stored accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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