Description

Fosfomycin cis-Propenyl Impurity is a critical reference standard and impurity used in the pharmaceutical development and quality control of the antibiotic Fosfomycin. This compound, with CAS No. 933443-26-6, is essential for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of this specific isomer during analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, testing, and approval of Fosfomycin-based medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the calibration of analytical instruments and validation of testing methods.
• Impurity Profiling and Control: Used in the identification and quantification of the cis-propenyl isomer as a process-related impurity in Fosfomycin API (Active Pharmaceutical Ingredient) batches.
• Method Development and Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Fosfomycin.
• Regulatory Compliance and 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.
• Quality Assurance/Quality Control (QA/QC): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of Fosfomycin.
• Stability Studies: Used to track the formation or increase of this impurity over time under various storage conditions.
• Research and Development: Utilized in synthetic chemistry research to study the isomerization pathways and optimize the Fosfomycin manufacturing process to minimize this impurity.

Basic Information

Product Name	Fosfomycin cis-Propenyl Impurity
CAS No.	933443-26-6
Molecular Formula	C7H15O6P
Molecular Weight	226.17 g/mol
Synonyms	(1R,2S)-1,2-Epoxypropylphosphonic Acid cis-Propenyl Ester; (Z)-1,2-Epoxypropylphosphonic Acid 1-Propenyl Ester; Fosfomycin cis-1-Propenyl Ester; Fosfomycin Z-Isomer Impurity; Fosfomycin Related Compound C; (Z)-Fosfomycin Propenyl Ester; cis-Fosfomycin Propenyl Ester
EINECS	Contact for details

Quality Control

Our Fosfomycin cis-Propenyl Impurity is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, residual solvent analysis, and structural confirmation (NMR, MS), to ensure identity, strength, and purity. We provide full traceability and Certificates of Analysis (COA) are available for every lot, supporting compliance with ICH Q3A/B guidelines and regulatory requirements for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing at 2-8°C. 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 ≤ 0.5% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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