Description

Ceftibuten CAS NO 97519-39-6 is a third-generation, orally active cephalosporin antibiotic belonging to the β-lactam class. It is valued for its broad-spectrum activity against a wide range of Gram-negative and some Gram-positive bacteria, offering a critical therapeutic option. This active pharmaceutical ingredient (API) is essential for pharmaceutical manufacturers developing effective oral antibiotic formulations. Its primary use is in the treatment of respiratory tract, urinary tract, and other bacterial infections, providing a convenient oral alternative to injectable cephalosporins.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of oral antibiotic capsules, tablets, and suspensions.
• Respiratory Infection Treatment: Formulated for treating bronchitis, pneumonia, and other lower respiratory tract infections.
• Urinary Tract Infection (UTI) Treatment: Used in medications targeting acute cystitis and pyelonephritis.
• Pediatric Formulations: Incorporated into stable, palatable oral suspensions for pediatric use.
• Clinical Research: Serves as a reference standard and raw material in antimicrobial research and development.
• Generic Drug Manufacturing: A key component for companies producing bioequivalent generic versions of branded ceftibuten medications.

Basic Information

Product Name	Ceftibuten
CAS No.	97519-39-6
Molecular Formula	C15H14N4O6S2
Molecular Weight	410.42 g/mol
Synonyms	Ceftibuten; (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; Sch 39720; Cedax (brand name); Cefibuten; 7-[2-(2-Aminothiazol-4-yl)-4-carboxybut-2-enamido]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
EINECS	Contact for details

Quality Control

Our Ceftibuten is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical use, including identification, assay (HPLC), and impurity profile analysis. We adhere to cGMP (current Good Manufacturing Practice) guidelines, and a detailed Certificate of Analysis (COA) is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.2%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Microbial Limits	Meets Ph. Eur./USP requirements

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