Description

Avibactam Impurity 1 is a specified impurity of the novel β-lactamase inhibitor, Avibactam, used in combination antibiotic therapies. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, quality control, and regulatory compliance. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the production and validation of Avibactam-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Avibactam Impurity 1 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing to ensure Avibactam batches meet stringent purity specifications as per ICH, USP, or EP guidelines.
• Stability Studies: Used to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Avibactam.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis and purification processes of Avibactam to minimize impurity formation.

Basic Information

Product Name	Avibactam Impurity 1
CAS No.	2243810-78-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	NXL-104 Impurity 1; AVI-IMP-1; (2S,5R)-7-oxo-2-(sulfooxy)-1,6-diazabicyclo[3.2.1]octane-6-sulfonate Impurity; Avibactam Related Compound 1; β-Lactamase Inhibitor Impurity; UNII-9H5BA9K2A8 Impurity; Diazabicyclooctane sulfonate impurity
EINECS	Contact for details

Quality Control

Our Avibactam Impurity 1 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. Certificates of Analysis (COA) with detailed chromatographic data (e.g., HPLC purity) are provided and traceable to primary standards. The material is suitable for use under current Good Manufacturing Practice (cGMP) and ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. This material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

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 unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.