Description

Fosfomycin Tromethamine is a broad-spectrum antibiotic salt, widely recognized for its unique mechanism of action and clinical efficacy. This compound is critical for pharmaceutical manufacturers and research institutions developing treatments for bacterial infections, particularly those caused by multidrug-resistant organisms. It is primarily utilized in the production of oral and injectable antibiotic formulations, serving the global pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Active Ingredient (API): Primary use in the manufacture of oral capsules, tablets, and injectable solutions for the treatment of uncomplicated urinary tract infections (UTIs).
• Veterinary Medicine: Formulation of antibiotic treatments for bacterial infections in livestock and companion animals.
• Clinical Research: Used as a reference standard and active component in studies investigating new antibacterial therapies and combination treatments.
• Antibiotic Resistance Research: A key tool in microbiological studies focused on understanding and combating bacterial resistance mechanisms.
• GMP Manufacturing: Sourced by contract development and manufacturing organizations (CDMOs) for the production of finished dosage forms under Good Manufacturing Practices.

Basic Information

Product Name	Fosfomycin Tromethamine
CAS No.	78964-85-9
Molecular Formula	C7H18NO6P
Molecular Weight	259.20 g/mol
Synonyms	Fosfomycin Trometamol; (3-Methyloxiranyl)phosphonic Acid Tromethamine Salt; Phosphomycin Tromethamine; Tromethamine Salt of Fosfomycin; Monurol (Trade Name); Fosfomycin Trometamol Salt; (-)-(1R,2S)-1,2-Epoxypropylphosphonic Acid Tromethamine Salt; Antibiotic FR-31564
EINECS	Contact for details

Quality Control

Our Fosfomycin Tromethamine is produced and tested to meet exacting pharmaceutical standards. Quality is assured through a comprehensive battery of analytical tests including identification, assay, impurity profiling, and residual solvent analysis. We provide full traceability and support regulatory submissions with Certificates of Analysis (COA) and can align with relevant pharmacopoeial standards (e.g., USP, EP) upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Specific Rotation	-13.0° to -16.0° (c=1 in H2O)
Heavy Metals	≤ 20 ppm
Bacterial Endotoxins	< 0.17 IU/mg (if for injectable use)
Microbial Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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