Description

Cefditoren Impurity 3 is a specified impurity and degradation product of the third-generation cephalosporin antibiotic, Cefditoren. This compound is critical for pharmaceutical research and development, serving as a key reference standard for quality control and analytical method validation. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Cefditoren active pharmaceutical ingredients (APIs) and finished drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefditoren Impurity 3 in API and drug product testing.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., ICH Q3A/B, USP, EP).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as per ICH guidelines.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval processes.
• Process Chemistry R&D: Aids in the optimization of synthesis and purification processes to minimize the formation of this impurity.

Basic Information

Product Name	Cefditoren Impurity 3
CAS No.	878002-85-8
Molecular Formula	C19H18N6O5S3
Molecular Weight	506.58 g/mol
Synonyms	(6R,7R)-7-[(2Z)-2-(2-Amino-4-thiazolyl)-2-methoxyiminoacetamido]-3-[(Z)-2-(4-methyl-5-thiazolyl)ethenyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; Cefditoren Related Compound C; Cefditoren EP Impurity C; Cefditoren USP Impurity C; Cefditoren Impurity C; (6R,7R)-7-[(Z)-2-(2-Aminothiazol-4-yl)-2-methoxyiminoacetamido]-3-[(Z)-2-(4-methylthiazol-5-yl)vinyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
EINECS	Contact for details

Quality Control

Our Cefditoren Impurity 3 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for use as a pharmaceutical reference standard. Certificates of Analysis (COA) are provided, detailing batch-specific results and confirming compliance with relevant specifications. We support compliance with ICH, USP, and EP guidelines.

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 light-sensitive; ensure the container is kept tightly sealed in a desiccated environment to maintain stability and purity.

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 single unknown impurity ≤ 1.0%
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.