Description

Aztreonam Impurity 8 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 impurity profiling, method validation, and quality control testing of active pharmaceutical ingredients (APIs) and finished drug products.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Aztreonam API and formulations.
• Method Development and Validation (HPLC/LC-MS) in analytical laboratories for establishing impurity profiles.
• Quality Control & Assurance (QC/QA) to monitor and control impurity levels during drug manufacturing processes.
• Regulatory Compliance and Documentation for submissions to agencies like the FDA, EMA, and other global health authorities.
• Stability Studies to track the formation of degradation products in aztreonam under various storage conditions.
• Research and Development (R&D) for studying the degradation pathways and chemistry of monobactam antibiotics.

Basic Information

Product Name	Aztreonam Impurity 8
CAS No.	171018-37-4
Molecular Formula	C13H17N5O8S2
Molecular Weight	435.44 g/mol
Synonyms	(2S,3S)-2-[[(2S)-2-Amino-4-oxo-4-sulfobutyl]amino]-3-methyl-4-oxo-1-sulfoazetidine; Aztreonam Open Ring Impurity; Aztreonam Degradation Product; Aztreonam Related Compound 8; Azactam Impurity 8; SQ 26,992 Impurity; Monobactam Impurity
EINECS	Contact for details

Quality Control

Every batch of Aztreonam Impurity 8 is manufactured and tested under strict quality systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and accurate identification, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity data 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 powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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