Description

Cefixime Oxide Impurity (Cefixime Sulfoxide) is a critical pharmaceutical reference standard and impurity used in the research, development, and quality control of the third-generation cephalosporin antibiotic, Cefixime. This compound is essential for ensuring the purity, safety, and efficacy of the final drug product by serving as a key marker for oxidative degradation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with stringent pharmacopeial standards such as USP and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Cefixime Sulfoxide in Cefixime Active Pharmaceutical Ingredient (API) and finished drug formulations.
• Analytical Method Development & Validation: A critical component in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for purity analysis.
• Stability-Indicating Studies: Employed in forced degradation studies to understand the oxidative degradation pathway of Cefixime and establish shelf-life specifications.
• Quality Control & Batch Release: Essential for routine QC testing to monitor impurity levels and ensure every batch of Cefixime API meets regulatory specifications for impurities.
• Regulatory Submissions: Used to generate data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other submissions to agencies like the FDA and EMA.
• Research & Development: Supports R&D efforts in synthesizing purer forms of Cefixime and developing more stable formulations.

Basic Information

Product Name	Cefixime Oxide Impurity (Cefixime Sulfoxide)
CAS No.	1335555-87-7
Molecular Formula	C16H15N5O7S2
Molecular Weight	453.45 g/mol
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-carboxyvinyl]amino]-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid 5,5-dioxide; Cefixime Sulfoxide Impurity; Cefixime EP Impurity G; Cefixime Sulfoxide; Cefixime Oxidative Degradation Product; Cefixime Related Compound G; (6R,7R)-7-[(Z)-2-(2-Aminothiazol-4-yl)-2-carboxyvinylamino]-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid 5,5-dioxide
EINECS	Contact for details

Quality Control

Our Cefixime Sulfoxide is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical impurity analysis. Each batch is characterized using advanced techniques including HPLC, MS, and NMR to confirm identity and purity. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, and our quality management system supports compliance with relevant pharmacopeial guidelines (USP, EP) and ICH Q3B(R2) for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

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)	Total impurities ≤ 5.0% Any individual unspecified 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.