Description

Cefamandole Nafate Impurity C (Ep) is a specified impurity of the second-generation cephalosporin antibiotic, Cefamandole Nafate. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development, validation, and quality control testing. It is essential for manufacturers, analytical laboratories, and regulatory bodies requiring precise identification and quantification of impurities to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards such as the European Pharmacopoeia (EP).

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Cefamandole Nafate Impurity C in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-High-Performance Liquid Chromatography (UHPLC), and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure impurity levels are within the limits specified by pharmacopeias (EP, USP) and ICH guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) to establish product shelf-life.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., CMC sections of dossiers for FDA, EMA) by providing definitive proof of impurity characterization and control strategies.
• Research on Degradation Pathways: Aids in research to understand the chemical degradation mechanisms of Cefamandole Nafate, leading to improved formulation and packaging strategies.

Basic Information

Product Name	Cefamandole Nafate Impurity C (Ep)
CAS No.	36922-16-4
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; Mandol Impurity C; Cefamandole Related Compound C; Cefamandole Nafate EP Impurity C; 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid, 7-[[(2R)-2-hydroxy-2-phenylacetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-, (6R,7R)-; Cefamandole Acid
EINECS	Contact for details

Quality Control

Every batch of Cefamandole Nafate Impurity C (Ep) is manufactured and analyzed under strict quality management systems. The product is characterized and qualified against pharmacopeial standards (EP) using advanced analytical techniques including HPLC, NMR, and MS to ensure high purity and definitive identity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile results. Our quality protocols are designed to support GMP-compliant applications and regulatory submissions.

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 dry conditions to prevent degradation. For long-term storage, consider desiccated conditions.

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%
Assay	≥ 90.0% (on dried basis)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits
Heavy Metals	≤ 20 ppm

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