Description

Cefamandole Nafate Impurity A (Ep) is a specified impurity and reference standard used in the analytical profiling of the antibiotic Cefamandole Nafate. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in the development, production, and regulatory compliance of cephalosporin antibiotics.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefamandole Nafate Impurity A in drug substance and finished product testing.
• 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): A critical component in impurity profiling to ensure batch-to-batch consistency and compliance with pharmacopoeial standards (e.g., USP, EP).
• Stability Studies: Employed to monitor the formation of degradation products in Cefamandole Nafate under various stress conditions.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Research & Development: Used in synthetic chemistry and analytical research to study the degradation pathways and stability of cephalosporin drugs.

Basic Information

Product Name	Cefamandole Nafate Impurity A (Ep)
CAS No.	68506-34-3
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; Mandelamide, N-[(7R)-2-carboxy-8-oxo-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-en-7-yl]-2-phenyl-, (2R)-; Cefamandole Impurity A; Cefamandole Related Compound A; EP Impurity A of Cefamandole Nafate
EINECS	Contact for details

Quality Control

Our Cefamandole Nafate Impurity A (Ep) is manufactured and handled under strict quality systems. Each batch is subjected to rigorous analytical testing, including HPLC for purity confirmation and structural verification by spectroscopic methods (IR, NMR). We provide comprehensive Certificates of Analysis (COA) that detail batch-specific results, ensuring traceability and compliance with relevant pharmacopoeial guidelines. The material is suitable for use as a reference standard in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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. Handle the container with care to prevent moisture ingress.

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 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.