Description

Cefditoren Impurity 10, Ring Open Dimer 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 analytical method development, stability studies, and quality control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Cefditoren-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefditoren Impurity 10 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating precise HPLC, UPLC, or LC-MS methods for impurity profiling of Cefditoren.
• Stability and Forced Degradation Studies: Employed to monitor the formation of this specific dimeric impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Quality Control & Batch Release Testing: A critical component in the quality control workflow to ensure batches of Cefditoren API meet stringent impurity limits as per ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for submission to agencies like the US FDA and EMA.
• Research on Degradation Pathways: Facilitates chemical research to understand the degradation mechanisms of Cefditoren, aiding in the formulation of more stable drug products.

Basic Information

Product Name	Cefditoren Impurity 10, Ring Open Dimer
CAS No.	878002-86-9
Molecular Formula	C38H40N8O12S4
Molecular Weight	920.99 g/mol
Synonyms	Cefditoren Dimer Impurity; Cefditoren Open Ring Dimer; Cefditoren Related Compound 10; (6R,7R)-7-[(2Z)-2-(2-Amino-4-thiazolyl)-2-methoxyiminoacetamido]-3-[(2Z)-2-(4-methyl-5-thiazolyl)ethenyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid Dimer; Pivoxil Hydrolyzed Dimer of Cefditoren; Cefditoren Impurity D (Ring Open Dimer); Cefditoren EP Impurity D
EINECS	Contact for details

Quality Control

Every batch of Cefditoren Impurity 10, Ring Open Dimer is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15°C and 25°C (59°F and 77°F), in a dry environment. The compound is light-sensitive (store away from light).

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%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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