Description

Nifuratel Impurity 4 is a high-purity chemical 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 degradation products in Nifuratel formulations under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Research & Development: Used in synthetic chemistry research to study the pathways of impurity formation and to develop purification processes.
• Quality Control & Assurance: Acts as a primary standard for routine quality control testing to ensure Nifuratel meets pharmacopeial specifications (e.g., USP, EP).

Basic Information

Product Name	Nifuratel Impurity 4
CAS No.	1445990-09-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nifuratel Related Compound 4; Nifuratel Impurity D; Nifuratel EP Impurity D; Nifuratel USP Impurity 4; 5-[(Methylamino)methyl]-3-[(5-nitrofurfurylidene)amino]-2-oxazolidinone Impurity; 1445990-09-9
EINECS	Contact for details

Quality Control

Every batch of Nifuratel Impurity 4 (CAS 1445990-09-9) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 maintain stability.

Specification

Item	Specification
Appearance	Off-white to light yellow powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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