Description

Fosfomycin Trometamolium Impurity is a high-purity chemical reference standard used in pharmaceutical research, development, and quality control. This compound is critical for the accurate identification, quantification, and monitoring of process-related impurities during the manufacture of the antibiotic Fosfomycin Trometamol. It is an essential material for analytical laboratories, regulatory compliance, and quality assurance departments within the global pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of specific impurities in Fosfomycin Trometamol active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, and other chromatographic methods for purity analysis.
• Quality Control (QC) Testing: Employed in routine QC laboratories to ensure batch-to-batch consistency and compliance with pharmacopeial standards (e.g., USP, EP, ICH guidelines).
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Fosfomycin Trometamol.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CMC documentation) to demonstrate control over the manufacturing process.
• Research & Development: Utilized in synthetic chemistry R&D to study reaction pathways and optimize processes to minimize impurity formation.

Basic Information

Product Name	Fosfomycin Trometamolium Impurity
CAS No.	26598-36-7
Molecular Formula	C7H18NO6P
Molecular Weight	243.20 g/mol
Synonyms	Fosfomycin Tromethamine Impurity; (2R,3S)-(3-Methyloxiran-2-yl)phosphonic Acid Trometamol Salt; Trometamol Salt of Fosfomycin; Phosphomycin Trometamol Impurity; (-)-(1R,2S)-1,2-Epoxypropylphosphonic Acid Trometamol Salt; Monurol Impurity; Antibiotic MK-955 Tromethamine Salt Impurity
EINECS	Contact for details

Quality Control

Our Fosfomycin Trometamolium Impurity is manufactured under strict quality systems to ensure the highest standards of purity and traceability. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results from advanced analytical techniques, including HPLC, NMR, and MS. We support compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines (USP, EP). Certificates of Analysis are available upon request.

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 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)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Specific Optical Rotation	Contact for details

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