Description

Ceftibuten Related Impurity 5 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antibiotic Ceftibuten during its development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and regulatory affairs teams. The precise characterization of this impurity is essential for method validation, stability studies, and meeting stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ceftibuten Related Impurity 5 in Ceftibuten drug substance and finished products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels against International Conference on Harmonisation (ICH) and pharmacopeial (USP, EP) limits.
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, humidity, light) as part of drug stability programs.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate thorough impurity characterization and control.
• Research & Development: Serves as a key intermediate or degradation product for studying the synthesis pathway, metabolism, and degradation mechanisms of Ceftibuten.

Basic Information

Product Name	Ceftibuten Related Impurity 5
CAS No.	92096-37-2
Molecular Formula	C15H14N4O6S2
Molecular Weight	410.42 g/mol
Synonyms	(6R,7R)-7-[(Z)-2-(2-Amino-4-thiazolyl)-4-carboxy-2-butenoylamino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; Ceftibuten Impurity 5; Ceftibuten EP Impurity C; (Z)-7-[2-(2-Aminothiazol-4-yl)-2-(carboxymethoxyimino)acetamido]-3-cephem-4-carboxylic Acid Related Compound; 7β-[(Z)-2-(2-Amino-4-thiazolyl)-4-carboxy-2-butenamido]-3-cephem-4-carboxylic Acid; Ceftibuten Related Compound C
EINECS	Contact for details

Quality Control

Every batch of Ceftibuten Related Impurity 5 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the exacting standards of pharmaceutical impurity supply, with testing typically including HPLC for assay and related substances, IR and MS for identification, and KF for water content. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with each 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 corresponds to 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
Residue on Ignition	≤ 0.5%

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