Description

Cefoxitin Ep Impurity D is a high-purity chemical reference standard, specifically identified as an impurity of the antibiotic Cefoxitin. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of the final drug product. It is primarily utilized by research institutions, quality control laboratories, and manufacturers within the pharmaceutical and biotechnology sectors for compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefoxitin Ep Impurity D in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to monitor batch-to-batch consistency and impurity levels in Cefoxitin sodium.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways and chemical behavior of Cefoxitin.

Basic Information

Product Name	Cefoxitin Ep Impurity D
CAS No.	1422023-33-3
Molecular Formula	C16H17N3O7S2
Molecular Weight	427.45 g/mol
Synonyms	(6R,7S)-3-[(Aminocarbonyl)oxy]methyl-7-methoxy-8-oxo-7-[(2-thienylacetyl)amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; 7-Methoxy-3-[(aminocarbonyl)oxy]methyl-8-oxo-7-[(2-thienylacetyl)amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; Cefoxitin Impurity D; Cefoxitin Related Compound D; Cefoxitin EP Impurity D
EINECS	Contact for details

Quality Control

Every batch of Cefoxitin Ep Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques (HPLC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

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 product 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)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Chromatographic Purity (HPLC)	Total related substances ≤ 2.0%

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