Description

Aztreonam Impurity B is a specified impurity and degradation product of the monobactam antibiotic Aztreonam. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Aztreonam drug substances and finished products. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Aztreonam Impurity B in drug substance and finished product analysis.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, for Aztreonam.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity profiles and ensure batches meet specifications set by USP, EP, or ICH guidelines.
• Stability Studies: Used to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary impurity data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough understanding and control of the drug's impurity profile.
• Research on Degradation Pathways: Facilitates research into the chemical degradation mechanisms of Aztreonam, aiding in formulation optimization.

Basic Information

Product Name	Aztreonam Impurity B
CAS No.	102586-36-7
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-4-oxo-1-sulfo-2-[[(2Z)-2-(2-amino-4-thiazolyl)-2-[(1-carboxy-1-methylethoxy)imino]acetyl]amino]azetidine; Aztreonam Open-ring Impurity; Aztreonam Degradant; SQ 26,992 Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Aztreonam Impurity B is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing to ensure identity, purity, and consistency, aligning with the requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced chromatographic and spectroscopic analyses. We support compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

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)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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