Description

Fosfomycin Trometamol Ep Impurity A is a specified impurity used in the quality control and analytical profiling of the antibiotic Fosfomycin Trometamol. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a reference standard in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Fosfomycin Trometamol formulations.

Application

• Primary use as a pharmaceutical reference standard for impurity identification and quantification.
• Critical component in analytical method development and validation (HPLC, LC-MS) for Fosfomycin Trometamol API.
• Essential for quality control (QC) and quality assurance (QA) testing in pharmaceutical manufacturing.
• Used in stability studies to monitor impurity profiles over time.
• Serves as a system suitability standard in regulatory compliance testing for pharmacopeial monographs (EP, USP).
• Supports research and development (R&D) of Fosfomycin Trometamol drug substances and products.

Basic Information

Product Name	Fosfomycin Trometamol Ep Impurity A
CAS No.	84954-80-3
Molecular Formula	C7H18NO6P
Molecular Weight	243.20 g/mol
Synonyms	(2R,3S)-(3-Methyloxiran-2-yl)phosphonic Acid Trometamol Salt; Fosfomycin Tromethamine Impurity A; (1R,2S)-Epoxypropylphosphonic Acid Trometamol Salt; Fosfomycin Trometamol Related Compound A; Tromethamine Salt of Fosfomycin Impurity A; Fosfomycin Trometamol EP Impurity A; Fosfomycin Trometamol USP Impurity A
EINECS	Contact for details

Quality Control

Our Fosfomycin Trometamol Ep Impurity A is manufactured and tested under strict quality systems. Each batch undergoes rigorous analytical testing to ensure high purity and accurate identification, aligning with pharmacopeial expectations for reference standards. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, assay, and chromatographic profile. We support compliance with EP, USP, and ICH 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); ensure the container is kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Water Content	≤ 2.0%
Residue on Ignition	≤ 0.1%

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