Description

Avibactam Impurity 5 is a designated reference standard used in the analytical profiling and quality control of the β-lactamase inhibitor, Avibactam. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in the development and validation of chromatographic methods for impurity identification and quantification in active pharmaceutical ingredient (API) batches.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Avibactam API.
• Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor and control impurity levels.
• Quality Assurance/Quality Control (QA/QC): Used in routine batch release testing to ensure Avibactam meets stringent pharmacopeial (e.g., USP, EP) specifications for impurity profiles.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data on impurity identity and levels for regulatory filings with agencies like the FDA and EMA.
• Research & Development: Aids in understanding the degradation pathways and chemical stability of the Avibactam molecule during formulation studies.

Basic Information

Product Name	Avibactam Impurity 5
CAS No.	1383913-01-6
Molecular Formula	C7H11N3O5S
Molecular Weight	249.25 g/mol
Synonyms	(2S,5R)-7-Oxo-6-(sulfoxy)-1,6-diazabicyclo[3.2.1]octane-2-carboxamide; NXL-104 Impurity 5; Avibactam Related Compound 5; (2S,5R)-1,6-Diazabicyclo[3.2.1]octane-2-carboxamide, 7-oxo-6-(sulfoxy)-; AVI Impurity 5
EINECS	Contact for details

Quality Control

Every batch of Avibactam Impurity 5 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.