Description

Cefuroxime Axetil Impurity C is a high-purity 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 antibiotic Cefuroxime Axetil by serving as a benchmark for impurity profiling and method validation. It is an essential material for analytical chemists, quality assurance laboratories, and regulatory affairs professionals within the global pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Cefuroxime Axetil Impurity C in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating high-performance liquid chromatography (HPLC), UPLC, and other chromatographic methods in QC laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing definitive impurity data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and stability studies.
• Quality Control & Batch Release Testing: Used in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines, ensuring batch-to-batch consistency.
• Research & Development: Facilitates impurity pathway studies, degradation profiling, and forced degradation studies during drug development and formulation optimization.
• Pharmacopoeial Testing: Supports testing to meet the specifications of pharmacopoeias such as USP (United States Pharmacopeia), EP (European Pharmacopoeia), and BP (British Pharmacopoeia).

Basic Information

Product Name	Cefuroxime Axetil Impurity C
CAS No.	76598-06-6
Molecular Formula	C20H22N4O10S
Molecular Weight	510.48 g/mol
Synonyms	(6R,7R)-3-[(Acetyloxy)methyl]-7-{[(2Z)-2-(2-furyl)-2-(methoxyimino)acetyl]amino}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; (6R,7R)-7-[(Z)-2-(2-Furyl)-2-(Methoxyimino)acetamido]-3-(acetoxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; Cefuroxime Axetil Acid Impurity; Cefuroxime Impurity C; Cefuroxime Axetil Related Compound C
EINECS	Contact for details

Quality Control

Our Cefuroxime Axetil Impurity C is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment. Our quality commitment aligns with cGMP principles to support your regulatory and compliance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation due to moisture absorption.

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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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