Description

Cefoxitin Impurity E CAS NO 2395025-32-6 is a high-purity chemical reference standard specifically identified as a process-related impurity of the antibiotic Cefoxitin. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily used by research institutions, quality assurance laboratories, and manufacturers of active pharmaceutical ingredients (APIs) to ensure the safety and efficacy of Cefoxitin-based drug products.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of Cefoxitin Impurity E in bulk drug substances and finished dosage forms.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods for Cefoxitin analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Facilitates studies on the synthesis pathway, degradation mechanisms, and purification processes of Cefoxitin.

Basic Information

Product Name	Cefoxitin Impurity E
CAS No.	2395025-32-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefoxitin Related Compound E; Cefoxitin EP Impurity E; Cefoxitin USP Impurity E; Cefoxitin Process Impurity; (6R,7S)-3-[(Carbamoyloxy)methyl]-7-methoxy-8-oxo-7-[(2-thienylacetyl)amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 3-[(aminocarbonyl)oxy]methyl]-7-methoxy-8-oxo-7-[(2-thienylacetyl)amino]-, (6R,7S)-; Thienylacetyl-7-ADCA derivative
EINECS	Contact for details

Quality Control

Our Cefoxitin Impurity E is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided with every shipment.

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.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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