Description

Ceftibuten Impurity 14 is a high-purity chemical reference standard used for analytical and quality control purposes in the pharmaceutical industry. This compound is critical for ensuring the purity, safety, and efficacy of the antibiotic Ceftibuten by enabling precise identification and quantification of related substances. It is an essential tool for analytical chemists, quality assurance laboratories, and research institutions involved in the development and manufacturing of cephalosporin antibiotics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Ceftibuten Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing to ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to monitor the formation of degradation products in Ceftibuten under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in studies to understand the degradation pathways and chemical behavior of Ceftibuten.

Basic Information

Product Name	Ceftibuten Impurity 14
CAS No.	110630-32-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(Z)-2-(2-Aminothiazol-4-yl)-2-(carboxymethoxyimino)acetic acid; (Z)-2-(2-Aminothiazol-4-yl)-2-[(carboxymethoxy)imino]acetic acid; Ceftibuten Impurity D; Ceftibuten Related Compound D; Ceftibuten Acid Impurity; 2-(2-Aminothiazol-4-yl)-2-[(carboxymethoxy)imino]acetic acid (Z)-isomer
EINECS	Contact for details

Quality Control

Every batch of Ceftibuten Impurity 14 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 must be kept in a desiccated environment to maintain stability and purity.

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%
Water Content	≤ 5.0%
Residue on Ignition	≤ 0.5%

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