Description

Aztreonam Impurities 06 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the monobactam antibiotic aztreonam. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Aztreonam Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels in compliance with ICH Q3A/B guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing within pharmaceutical manufacturing to ensure batch-to-batch consistency and purity specifications are met.
• Stability Studies: Used to track the formation of degradation products in Aztreonam formulations under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Facilitates research into the degradation pathways, metabolism, and chemical behavior of Aztreonam.

Basic Information

Item	Detail
Product Name	Aztreonam Impurities 06
CAS No.	730928-60-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Aztreonam Related Compound 06; Aztreonam Impurity 6; Aztreonam Degradant; Aztreonam Process Impurity; (2S,3S)-2-[[(2S,3S)-2-Amino-3-methyl-4-oxo-1-azetidinyl]oxy]-3-methyl-4-oxo-1-azetidinesulfonic Acid (related); Monobactam Impurity; CAS 730928-60-6
EINECS	Contact for details

Quality Control

Every batch of Aztreonam Impurities 06 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (IR, NMR, MS), to ensure compliance with high-grade reference standard specifications. 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 in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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