Description

Ceftibuten Dihydrate is a third-generation, orally active cephalosporin antibiotic. This compound is valued for its broad-spectrum activity against Gram-negative bacteria and enhanced stability against β-lactamases. It is a critical active pharmaceutical ingredient (API) primarily used in the formulation of oral antibiotic medications for the treatment of various bacterial infections. The product is supplied under the identifier CAS NO 118081-34-8.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of oral antibiotic capsules, tablets, and suspensions.
• Clinical Research: Serves as a reference standard and raw material in pharmacological and microbiological studies.
• Veterinary Medicine: Potential application in developing antibacterial treatments for veterinary use.
• Generic Drug Manufacturing: Essential for companies producing generic versions of ceftibuten-based medications.
• Contract Manufacturing Organizations (CMOs): Supplied to CMOs engaged in finished dosage form production for global markets.

Basic Information

Product Name	Ceftibuten Dihydrate
CAS No.	118081-34-8
Molecular Formula	C15H18N4O6S2 • 2H2O
Molecular Weight	446.46 g/mol (Anhydrous: 410.45 g/mol)
Synonyms	Ceftibuten; Ceftibuten Dihydrate; (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 dihydrate; Sch 39720; Cedax (brand name); Cefibuten; CEFTIBUTENUM
EINECS	Contact for details

Quality Control

Our Ceftibuten Dihydrate is manufactured under strict quality systems. Each batch is tested to ensure it meets high-purity standards suitable for pharmaceutical use. We provide comprehensive Certificates of Analysis (COA) that detail specifications including assay, related substances, water content, and residual solvents. The product is produced in compliance with cGMP guidelines, ensuring reliable quality and batch-to-batch consistency for our global B2B clients.

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 dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere packaging.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	7.0% - 9.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Specific Rotation	Contact for details
Microbial Limits	Complies with Ph. Eur./USP

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