Description

Fosfomycin Impurity B CAS NO 1262243-11-7 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critically important for pharmaceutical quality control, specifically in the development and validation of analytical methods for the antibiotic Fosfomycin. It is essential for laboratories and manufacturers requiring precise impurity profiling to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for method development and validation in HPLC, LC-MS, and other chromatographic techniques.
• Quality Control & Assurance: Critical for the identification and quantification of Fosfomycin Impurity B in active pharmaceutical ingredient (API) and finished drug product batches.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Research & Development: Used in stability studies, degradation pathway elucidation, and formulation research to understand the behavior of Fosfomycin under various conditions.
• Pharmacopoeial Testing: Employed in testing to meet the specifications of pharmacopoeias such as USP, EP, and JP for Fosfomycin and its related substances.
• Contract Research Organizations (CROs): Essential analytical tool for CROs providing outsourced pharmaceutical testing and development services.

Basic Information

Product Name	Fosfomycin Impurity B
CAS No.	1262243-11-7
Molecular Formula	C3H7O4P
Molecular Weight	138.06 g/mol
Synonyms	(1R,2S)-1,2-Epoxypropylphosphonic Acid; Fosfomycin Impurity; Fosfomycin Related Compound B; (-)-(1R,2S)-1,2-Epoxypropylphosphonic Acid; Phosphomycin Impurity B; (1R,2S)-(-)-1,2-Epoxypropylphosphonic Acid; Antibiotic MK-955 Impurity
EINECS	Contact for details

Quality Control

Our Fosfomycin Impurity B is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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