Description

(E)-Ceftibuten Dihydrate is a third-generation cephalosporin antibiotic intermediate, specifically the dihydrate form of the active pharmaceutical ingredient. This compound is critical for ensuring the efficacy and stability of the final antibiotic formulation, making it a key building block in pharmaceutical synthesis. It is primarily required by manufacturers in the pharmaceutical industry for the production of advanced oral antibiotic medications.

Application

• Active Pharmaceutical Ingredient (API) Synthesis: Primary use as a key intermediate in the manufacture of Ceftibuten, a broad-spectrum oral cephalosporin antibiotic.
• Pharmaceutical Research & Development: Serves as a critical reference standard and starting material in R&D for novel antibiotic formulations and combination therapies.
• Generic Drug Manufacturing: Essential for the production of generic versions of branded Ceftibuten-based medications, ensuring cost-effective treatment options.
• Veterinary Pharmaceuticals: Used in the development and production of antibiotic treatments for bacterial infections in animals.
• Quality Control & Analytical Testing: Employed as a high-purity standard in HPLC and other analytical methods to ensure batch consistency and regulatory compliance.

Basic Information

Product Name	(E)-Ceftibuten Dihydrate
CAS No.	1428117-81-0
Molecular Formula	C15H14N4O6S2 · 2H2O
Molecular Weight	446.43 g/mol
Synonyms	(6R,7R)-7-[(Z)-2-(2-Amino-4-thiazolyl)-4-carboxy-2-butenoylamino]-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid Dihydrate; Ceftibuten (E)-isomer Dihydrate; (E)-Ceftibuten Dihydrate; Ceftibuten Impurity; Cedax Intermediate; Antibiotic 7432-S Dihydrate
EINECS	Contact for details

Quality Control

Our (E)-Ceftibuten Dihydrate is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity and identity confirmation, to ensure it meets the stringent requirements for pharmaceutical intermediates. Certificates of Analysis (COA) are provided with each shipment, detailing all specified parameters. We can support compliance with cGMP, ICH Q7, and other relevant pharmaceutical guidelines.

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 desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Water Content (KF)	7.0% - 9.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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