Description

Cefpodoxime Proxetil Impurity E is a specified impurity of the broad-spectrum antibiotic Cefpodoxime Proxetil, identified by the CAS registry number 217803-89-9. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of the active pharmaceutical ingredient (API). It is essential for manufacturers, quality control laboratories, and regulatory bodies involved in ensuring the purity, safety, and efficacy of cephalosporin antibiotic formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Impurity E in Cefpodoxime Proxetil API and finished drug products.
• Method Development and Validation: Crucial for developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques, to monitor impurity profiles.
• Quality Assurance & Control (QA/QC): Used in routine batch testing to ensure API and drug product compliance with stringent pharmacopoeial standards (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to track the formation and levels of this specific degradation product under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies.
• Research on Degradation Pathways: Aids in studying the chemical stability and degradation mechanisms of Cefpodoxime Proxetil.

Basic Information

Item	Details
Product Name	Cefpodoxime Proxetil Impurity E
CAS No.	217803-89-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(6R,7R)-7-[(Z)-2-(2-Amino-4-thiazolyl)-2-(methoxyimino)acetamido]-3-(methoxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; Cefpodoxime Impurity E; Cefpodoxime Acid; Cefpodoxime Free Acid; (6R,7R)-7-[2-(2-Aminothiazol-4-yl)-2-(methoxyimino)acetamido]-3-(methoxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; Desisopropoxycarbonyl Cefpodoxime; Cefpodoxime Related Compound E
EINECS	Contact for details

Quality Control

Our Cefpodoxime Proxetil Impurity E is manufactured and handled under strict quality systems. Each batch undergoes rigorous analytical testing to ensure high purity and accurate identification, aligning with ICH Q3A/B guidelines and relevant pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, assay, and impurity profile by validated methods such as HPLC.

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 reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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