Description

Fosfomycin Trometamol Ep Impurity D is a high-purity chemical reference standard specifically identified and characterized for pharmaceutical analysis. This compound is critical for ensuring the quality, safety, and efficacy of the antibiotic Fosfomycin Trometamol by serving as a known impurity during method development and validation. It is an essential material for analytical laboratories and quality control departments within the global pharmaceutical and biotechnology sectors, particularly those involved in the production and regulatory compliance of antibiotic formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Fosfomycin Trometamol active pharmaceutical ingredient (API) and finished drug products.
• Method Development & Validation: Crucial for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-High-Performance Liquid Chromatography (UPLC) assays, in compliance with ICH guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor and control the level of this specific impurity, ensuring drug substance and product meet stringent pharmacopoeial specifications (e.g., EP, USP).
• Stability Studies: Employed to identify and quantify degradation products that may form under various stress conditions, supporting shelf-life determination and regulatory filings.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission documents (e.g., CMC sections for FDA, EMA) by providing definitive impurity profiling data.

Basic Information

Product Name	Fosfomycin Trometamol Ep Impurity D
CAS No.	1262243-12-8
Molecular Formula	C7H18NO6P
Molecular Weight	243.20 g/mol
Synonyms	(1R,2S)-(1,2-Epoxypropyl)phosphonic Acid Trometamol Salt; Fosfomycin Tromethamine Impurity D; (1R,2S)-1,2-Epoxypropylphosphonic Acid Trometamol Salt; Fosfomycin Trometamol Related Compound D; Tromethamine Salt of Fosfomycin Impurity D; EP Impurity D of Fosfomycin Trometamol; (3-Methyloxiran-2-yl)phosphonic Acid Trometamol Salt
EINECS	Contact for details

Quality Control

Every batch of Fosfomycin Trometamol Ep Impurity D is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive analytical characterization using techniques such as HPLC, NMR, and MS to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific results for purity, related substances, and other critical parameters. Our quality commitment aligns with the standards required for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material may be hygroscopic; keep the container tightly sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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