Description

Cefamandole Impurity 25 is a specified impurity and degradation product of the second-generation cephalosporin antibiotic, Cefamandole. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Cefamandole drug substances and finished products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefamandole Impurity 25 in active pharmaceutical ingredients (APIs) and formulations.
• Method Development and Validation: Essential for developing and validating analytical methods, such as HPLC and UPLC, to monitor impurities during stability studies and batch release testing.
• Quality Control & Assurance (QC/QA): Provides a benchmark for impurity profiling to ensure Cefamandole products meet the purity specifications outlined in pharmacopeias (e.g., USP, EP, JP).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as part of drug stability protocols.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive characterization data for impurity identification.
• Research on Degradation Pathways: Aids in research to understand the chemical degradation pathways of Cefamandole, helping to improve formulation and packaging strategies.

Basic Information

Product Name	Cefamandole Impurity 25
CAS No.	53434-90-5
Molecular Formula	C18H18N6O5S2
Molecular Weight	462.50 g/mol
Synonyms	(6R,7R)-7-[[(2R)-2-Hydroxy-2-phenylacetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Cefamandole Related Compound; Cefamandole Degradant; Cefamandole EP Impurity; Cefamandole USP Impurity; Mandol Impurity; Cefamandole Impurity C (in some monographs)
EINECS	Contact for details

Quality Control

Our Cefamandole Impurity 25 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for use as a reference material. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), and specified impurities. We support compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

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%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
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.