Description

Cefamandole Impurity C is a specified impurity of the second-generation cephalosporin antibiotic, Cefamandole. This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical method development and validation. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies for ensuring the purity, safety, and efficacy of Cefamandole-based drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefamandole Impurity C in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods to monitor impurities.
• Quality Control & Assurance: Employed in routine QC testing to ensure Cefamandole batches comply with pharmacopoeial standards (e.g., USP, EP) and ICH Q3A/B guidelines on impurities.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) during drug stability testing.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA) with agencies like the FDA and EMA.
• Research & Synthesis: Serves as a critical intermediate or marker in process chemistry research to optimize synthesis pathways and minimize impurity formation.

Basic Information

Item	Detail
Product Name	Cefamandole Impurity C
CAS No.	36922-15-3
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; 7-(D-Mandelamido)-3-[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-3-cephem-4-carboxylic acid; Cefamandole Related Compound C; Cefamandole EP Impurity C; Cefamandole USP Impurity C
EINECS	Contact for details

Quality Control

Our Cefamandole Impurity C is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines. Certificates are available upon request.

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 under inert conditions or in a desiccator 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%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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