Description

Aztreonam Impurity F is a specified impurity of the monobactam antibiotic Aztreonam, identified by CAS No. 102579-57-7. This high-purity reference standard is critical for pharmaceutical research, development, and quality control processes, ensuring the safety and efficacy of the final drug product. It is primarily used by analytical laboratories, quality assurance departments, and regulatory affairs teams within the pharmaceutical and biotechnology industries.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Aztreonam Impurity F in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity profiles and ensure compliance with stringent pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation impurities in Aztreonam under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Aids in studying the degradation pathways and chemical behavior of Aztreonam during formulation development.

Basic Information

Product Name	Aztreonam Impurity F
CAS No.	102579-57-7
Molecular Formula	C13H17N5O8S2
Molecular Weight	435.44 g/mol
Synonyms	(2S,3S)-2-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-[(1-carboxy-1-methylethoxy)imino]acetyl]amino]-3-methyl-4-oxo-1-sulfoazetidine; 3-Methyl-Aztreonam; Aztreonam Impurity 6; Aztreonam Related Compound F; SQ 26,992 Impurity F; Azactam Impurity F
EINECS	Contact for details

Quality Control

Our Aztreonam Impurity F is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile by validated methods such as HPLC. We support compliance with ICH guidelines and relevant pharmacopeial requirements.

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 product 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 reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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