Description

Nifuratel Impurity 4 CAS NO 3455-50-3 is a specified impurity standard used in the analytical profiling and quality control of the pharmaceutical substance Nifuratel. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and contract research organizations (CROs) involved in method development, validation, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Nifuratel Impurity 4 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC or UPLC methods to monitor impurity profiles during drug development and manufacturing.
• Quality Control & Batch Release: Used in routine QA/QC testing to ensure Nifuratel API meets stringent pharmacopeial (e.g., USP, EP) or internal specification limits for related substances.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing characterized impurity data required for drug approval.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Nifuratel, facilitating the development of more stable formulations.

Basic Information

Product Name	Nifuratel Impurity 4
CAS No.	3455-50-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nifuratel Related Compound 4; Nifuratel EP Impurity 4; Nifuratel USP Impurity 4; 5-(Methylamino)-3-[(5-nitrofurfurylidene)amino]-2-oxazolidinone; 3-[(5-Nitrofuran-2-yl)methylideneamino]-5-(methylamino)-1,3-oxazolidin-2-one; Nifuratel Impurity D (Potential); Nitrofuratel Impurity
EINECS	Contact for details

Quality Control

Our Nifuratel Impurity 4 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment. Our quality commitment supports compliance with cGMP and relevant ICH guidelines for impurities in pharmaceutical substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	Yellow to orange crystalline powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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