Description

Fosfomycin Trometamol Impurity 10 is a specified impurity and reference standard used in the analytical profiling and quality control of Fosfomycin Trometamol, a broad-spectrum antibiotic. This high-purity compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the safety, efficacy, and regulatory compliance of the final drug product. It is primarily utilized in research and development, method validation, and routine batch release testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of this specific impurity in Fosfomycin Trometamol API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Quality Control & Batch Release: A critical component in the QC laboratory for routine testing to ensure impurity levels are within ICH/USP/EP specified limits.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Pharmacopoeial Testing: Used for compliance testing against monographs in the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and other international pharmacopoeias.

Basic Information

Product Name	Fosfomycin Trometamol Impurity 10
CAS No.	28423-96-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fosfomycin Tromethamine Impurity 10; Fosfomycin Trometamol Related Compound 10; Impurity 10 of Fosfomycin Trometamol; (1R,2S)-1,2-Epoxypropylphosphonic Acid Trometamol Salt Impurity 10; (-)-(1R,2S)-1,2-Epoxypropylphosphonic Acid Trometamol Salt Impurity 10; Fosfomycin Trometamol EP Impurity J; Fosfomycin Trometamol USP Related Compound J
EINECS	Contact for details

Quality Control

Every batch of Fosfomycin Trometamol Impurity 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopoeial standards (USP, EP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing all test results, including chromatographic purity and impurity profile, is provided with each shipment.

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 handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

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

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