Description

Cefepime Impurity 14 is a designated chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the purity, safety, and efficacy of the fourth-generation cephalosporin antibiotic, Cefepime, by serving as a benchmark in chromatographic analysis. It is an essential material for analytical chemists, quality assurance professionals, and researchers working in pharmaceutical R&D, regulatory compliance, and contract manufacturing organizations (CMOs).

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Cefepime Impurity 14 in active pharmaceutical ingredient (API) batches.
• Method Development and Validation: Crucial for developing and validating robust analytical methods, such as High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC).
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to monitor impurity profiles and ensure Cefepime API meets stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., Drug Master Files, CMC sections) by providing characterized impurity data for health authorities like the FDA and EMA.
• Stability Studies: Employed as an analytical marker in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Research and Development: Facilitates process chemistry research aimed at understanding and minimizing the formation of this impurity during Cefepime synthesis.

Basic Information

Item	Detail
Product Name	Cefepime Impurity 14
CAS No.	1338489-58-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefepime Related Compound 14; Cefepime EP Impurity 14; Cefepime USP Impurity 14; Cefepime Impurity F; (6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino]-3-[(1-methylpyrrolidin-1-ium-1-yl)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate (putative); Cefepime Process Impurity; Cephalosporin Impurity
EINECS	Contact for details

Quality Control

Every batch of Cefepime Impurity 14 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including ICH guidelines. Comprehensive characterization is performed using advanced spectroscopic and chromatographic techniques. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere 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%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown 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.