Description

Cefpodoxime Proxetil Ep Impurity C is a specified impurity of the broad-spectrum antibiotic Cefpodoxime Proxetil, identified by CAS No. 339528-86-8. This compound is critical for pharmaceutical research and development, serving as a key reference standard for ensuring drug purity, safety, and regulatory compliance. It is primarily required by analytical laboratories, quality control units, and manufacturers engaged in the synthesis and production of Cefpodoxime Proxetil API and finished dosage forms.

Application

• Primary use as a pharmaceutical reference standard for identity, purity, and assay testing.
• Critical component in analytical method development and validation (HPLC, LC-MS) for Cefpodoxime Proxetil.
• Essential for impurity profiling and control during API (Active Pharmaceutical Ingredient) manufacturing.
• Used in stability studies to monitor degradation pathways and establish shelf-life.
• Supports regulatory submissions (e.g., for FDA, EMA) by providing certified impurity material.
• Facilitates quality assurance and compliance with pharmacopoeial standards (EP, USP).
• Valuable for research and development of related cephalosporin antibiotics.

Basic Information

Product Name	Cefpodoxime Proxetil Ep Impurity C
CAS No.	339528-86-8
Molecular Formula	C21H27N5O9S2
Molecular Weight	557.60 g/mol
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-(methoxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid 1-(Isopropoxycarbonyloxy)ethyl Ester Impurity C; Cefpodoxime Impurity C; 1-[[(6R,7R)-7-[[(2Z)-2-(2-Amino-4-thiazolyl)-2-(methoxyimino)acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-3-methylimidazolium Hydroxide, Inner Salt, 1-(Isopropoxycarbonyloxy)ethyl Ester; Cefpodoxime Proxetil Related Compound C
EINECS	Contact for details

Quality Control

Our Cefpodoxime Proxetil Ep Impurity C is manufactured and controlled under a strict quality management system. Each batch is characterized and tested using advanced analytical techniques to ensure identity, purity, and consistency, meeting the requirements for use as a high-grade reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual impurity ≤ 2.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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