Description

Avibactam Impurity 30 is a designated process-related impurity associated with the synthesis of the β-lactamase inhibitor, Avibactam. This compound is critical for pharmaceutical research and development, particularly in ensuring the purity and safety profile of the final active pharmaceutical ingredient (API). It is primarily used by analytical chemists and quality control laboratories in the pharmaceutical industry for method development, validation, and as a reference standard in impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Avibactam and its related substances.
• Impurity Profiling & Characterization: Essential for identifying, monitoring, and controlling this specific impurity during Avibactam API manufacturing to meet ICH Q3A/B guidelines.
• Analytical Method Development & Validation: Serves as a key component in developing and validating stability-indicating HPLC/UPLC methods for Avibactam drug substances and products.
• Quality Control & Batch Release: Employed in routine QC testing to ensure batch-to-batch consistency and compliance with stringent regulatory specifications.
• Stability Studies: Used to track the formation and levels of this impurity under various stress conditions (e.g., heat, light, humidity) as part of forced degradation studies.
• Regulatory Submissions: Provides necessary data on impurity identity, structure, and toxicological qualification for regulatory filings (e.g., FDA, EMA).

Basic Information

Product Name	Avibactam Impurity 30
CAS No.	2392914-53-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Avibactam Related Compound 30; Avibactam Process Impurity 30; (2S,5R)-7-oxo-2-[(sulfooxy)amino]-1,6-diazabicyclo[3.2.1]octane-6-carboxylic acid impurity; NXL-104 Impurity 30; AVIBASTAT Impurity 30; UNII-Contact for details; IUPAC Name: Contact for details
EINECS	Contact for details

Quality Control

Our Avibactam Impurity 30 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, spectroscopic identification (NMR, MS, IR), and determination of residual solvents and moisture content to ensure it meets the high standards required for pharmaceutical impurity standards. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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