Description

Ceftibuten Related Impurity 6 is a high-purity chemical reference standard critical for the analytical profiling and quality control of the antibiotic Ceftibuten. This compound is essential for pharmaceutical manufacturers and analytical laboratories to identify, quantify, and control this specific impurity, ensuring the final drug product meets stringent regulatory purity and safety standards. It is primarily used in research and development, method validation, and routine quality testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ceftibuten Related Impurity 6 in Ceftibuten API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for preparing calibration curves in routine batch release testing to ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH stability protocols.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Research & Development: Used in synthetic chemistry research to study impurity formation pathways and to develop improved purification processes for Ceftibuten.

Basic Information

Item	Details
Product Name	Ceftibuten Related Impurity 6
CAS No.	57028-71-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Amino-4-thiazolyl)-4-carboxy-1-oxo-2-butenyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Ceftibuten Impurity 6; Ceftibuten EP Impurity 6; Ceftibuten Related Compound 6; (Z)-Isomer of Ceftibuten; Antibiotic Impurity Standard; 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid Derivative
EINECS	Contact for details

Quality Control

Our Ceftibuten Related Impurity 6 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identification by spectroscopic methods (IR, NMR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
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.