Description

Fosfomycin Trometamol Impurity C is a specified impurity and reference standard used in the quality control of the antibiotic Fosfomycin Trometamol. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) during development and manufacturing. It is primarily required by pharmaceutical companies, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Fosfomycin Trometamol Impurity C in API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: A critical component in the QC testing of Fosfomycin Trometamol to ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation and level of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization.
• Research & Development: Used in R&D laboratories for studying the degradation pathways and chemical behavior of Fosfomycin Trometamol.

Basic Information

Product Name	Fosfomycin Trometamol Impurity C
CAS No.	23001-39-0
Molecular Formula	C7H18NO6P
Molecular Weight	243.20 g/mol
Synonyms	(2R,3S)-(3-Methyloxiran-2-yl)phosphonic Acid Tromethamine Salt; (1R,2S)-Epoxypropylphosphonic Acid Trometamol Salt; Fosfomycin Tromethamine Impurity C; (3-Methyloxiran-2-yl)phosphonic Acid Compound with 2-Amino-2-(hydroxymethyl)propane-1,3-diol; Fosfomycin Trometamol Related Compound C
EINECS	Contact for details

Quality Control

Our Fosfomycin Trometamol Impurity C is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for identity, purity, and related substances, compliant with ICH guidelines. The material is suitable for use as a pharmaceutical reference standard in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
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.