Description

4H-Furo[2,3-C]Pyranyl Mupirocin Sodium Impurity is a high-purity chemical reference standard critical for ensuring the quality and safety of the antibiotic Mupirocin Sodium. This compound serves as a key analytical marker for pharmaceutical manufacturers and quality control laboratories to identify, quantify, and control process-related impurities during drug development and production. It is essential for companies in the pharmaceutical and fine chemical sectors requiring rigorous analytical validation and regulatory compliance for their active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Mupirocin Sodium bulk drug and finished formulations.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing definitive impurity characterization data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to monitor impurity levels in Mupirocin Sodium under various stress conditions to establish shelf-life and storage recommendations.
• Process Chemistry Research: Aids chemists in optimizing synthesis and purification processes to minimize the formation of this specific impurity.
• Quality Assurance/Quality Control (QA/QC): Serves as a primary standard for routine batch release testing to ensure product purity meets pharmacopeial specifications (USP, EP).

Basic Information

Product Name	4H-Furo[2,3-C]Pyranyl Mupirocin Sodium Impurity
CAS No.	116182-43-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Mupirocin Sodium Impurity; Mupirocin Related Compound; Pseudomonic Acid A Impurity; 4H-Furo[2,3-c]pyran-4-one, 5,6-dihydro-5-hydroxy-4,6-dimethyl-2-(1-oxohexyl)-, sodium salt; Bactroban Impurity; (E)-9-[(2S,3R,4R,5S)-3,4-Dihydroxy-5-[[(2S,3S)-3-[(2S,3S)-3-hydroxybutan-2-yl]oxiran-2-yl]methyl]oxan-2-yl]-3-methylnon-2-enoic acid impurity
EINECS	Contact for details

Quality Control

Our 4H-Furo[2,3-C]Pyranyl Mupirocin Sodium Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic and should be handled in a dry environment to prevent moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 5.0% w/w

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