Description

Nifuratel Impurity 32 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Nifuratel. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Nifuratel API batches.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of this impurity during forced degradation and long-term stability testing of drug products.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Research & Development: Used in R&D to study the degradation pathways and chemical behavior of Nifuratel.
• Quality Control & Assurance: Acts as a benchmark in routine QC testing to ensure API purity meets pharmacopeial standards (e.g., USP, EP).

Basic Information

Product Name	Nifuratel Impurity 32
CAS No.	98264-38-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nifuratel Related Compound 32; Nifuratel EP Impurity 32; Nifuratel USP Impurity 32; 5-(Methylamino)-3-[(5-nitrofurfurylidene)amino]-2-oxazolidinone; Methylamino Nitrofuryl Oxazolidinone Impurity; 98264-38-1; Nifuratel Degradation Product
EINECS	Contact for details

Quality Control

Our Nifuratel Impurity 32 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and spectroscopic methods for structural verification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and traceability is provided with every 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). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	Off-white to yellow powder
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	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.