Description

Cefixime Impurity G is a specified impurity of the broad-spectrum cephalosporin antibiotic, Cefixime. This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical method development and validation. It is primarily used by quality control laboratories and regulatory affairs departments to ensure the purity, safety, and efficacy of Cefixime drug substances and finished products.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of Cefixime Impurity G in active pharmaceutical ingredients (APIs).
• Essential for analytical method development and validation (HPLC, UPLC) in compliance with ICH guidelines.
• Critical component in stability studies to monitor impurity profiles and establish shelf-life for Cefixime formulations.
• Used in regulatory submissions to health authorities (e.g., FDA, EMA) to demonstrate comprehensive impurity control.
• Supports quality control and assurance processes in pharmaceutical manufacturing to meet pharmacopeial standards (USP, EP).
• Valuable for research and development of Cefixime synthesis pathways and impurity formation studies.

Basic Information

Product Name	Cefixime Impurity G
CAS No.	130136-31-1
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; 7β-[2-(2-Aminothiazol-4-yl)-(Z)-2-carboxyvinylamino]-3-vinyl-3-cephem-4-carboxylic Acid; Cefixime Related Compound G; Cefixime EP Impurity G; Cefixime USP Impurity G
EINECS	Contact for details

Quality Control

Our Cefixime Impurity G is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each batch is fully characterized and undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods. A comprehensive Certificate of Analysis (COA) is provided, detailing all test results against relevant pharmacopeial standards (USP/EP).

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 should be handled in a dry environment to prevent degradation.

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 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.