Description

Avibactam Impurity 15 is a designated process-related impurity and reference standard used in the analytical profiling of the β-lactamase inhibitor, Avibactam. This compound is critical for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API) by enabling precise identification and quantification during quality control. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and manufacturers involved in the synthesis and regulatory compliance of Avibactam-based antibiotic combinations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for method development, validation, and routine quality control testing of Avibactam API.
• Analytical Method Development: Used to develop and optimize chromatographic methods (e.g., HPLC, UPLC) for the separation and detection of impurities in Avibactam.
• Stability Studies: Employed as a marker to monitor the formation of degradation products under various stress conditions (e.g., heat, humidity, light) as per ICH guidelines.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., CMC sections for FDA, EMA) by providing necessary impurity characterization data.
• Process Chemistry Research: Aids in understanding and optimizing the Avibactam synthesis pathway by identifying and controlling the formation of this specific impurity.
• Quality Assurance Benchmarking: Serves as a benchmark to establish acceptance criteria and specifications for Avibactam batches in compliance with pharmacopeial standards.

Basic Information

Product Name	Avibactam Impurity 15
CAS No.	1416134-60-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	NXL-104 Impurity 15; AVI-IMP-15; (2S,5R)-7-oxo-2-[(sulfooxy)amino]-1,6-diazabicyclo[3.2.1]octane-6-sulfonic acid impurity; Avibactam Related Compound 15; β-lactamase inhibitor impurity; Process impurity of Avibactam; AVI Related Substance 15
EINECS	Contact for details

Quality Control

Every batch of Avibactam Impurity 15 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced analytical techniques to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for purity, assay, and related substances is provided with each 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). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.