Description

Aztreonam Impurity 5 is a specified impurity of the monobactam antibiotic Aztreonam, identified by the CAS number 2195336-17-3. This high-purity reference standard is critical for pharmaceutical research, development, and quality control processes to ensure the safety and efficacy of the final drug product. It is primarily needed by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies involved in the synthesis, purification, and validation of Aztreonam and related antibiotic formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Aztreonam Impurity 5 in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development & Validation: Essential for developing and validating analytical methods, such as HPLC, UPLC, and LC-MS, to monitor impurities during the manufacturing process.
• Quality Control & Assurance (QC/QA): Serves as a critical benchmark in quality control laboratories to ensure Aztreonam batches meet stringent pharmacopeial standards (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed in forced degradation and long-term stability studies to profile impurity formation and establish shelf-life for Aztreonam formulations.
• Regulatory Compliance & Filings: Supports the preparation of regulatory submission documents (e.g., CMC sections for FDA, EMA) by providing necessary impurity characterization data.
• Research on Degradation Pathways: Aids in research to understand the chemical degradation pathways of Aztreonam, helping to improve synthesis and formulation strategies.

Basic Information

Product Name	Aztreonam Impurity 5
CAS No.	2195336-17-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Aztreonam Related Compound 5; Aztreonam EP Impurity 5; Aztreonam USP Impurity 5; (2S,3S)-2-[[(2S)-2-Amino-4-oxo-4-[[(3S)-2-oxo-1-sulfo-3-azetidinyl]amino]butanoyl]amino]-3-methylpentanoic acid; Aztreonam Degradant; Monobactam Impurity
EINECS	Contact for details

Quality Control

Our Aztreonam Impurity 5 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic and spectroscopic methods, including HPLC, NMR, and MS. We adhere to relevant ICH guidelines and support compliance with pharmacopeial standards (USP, EP).

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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to Off-white powder
Identification (HPLC)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual 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.