Description

Nifuratel Impurity CAS NO 167103-07-3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of process-related impurities in the active pharmaceutical ingredient Nifuratel. It is an essential material for analytical laboratories, research institutions, and manufacturers engaged in the development, validation, and routine testing of Nifuratel-based pharmaceutical products to ensure safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for identifying and quantifying specific impurities during Nifuratel API (Active Pharmaceutical Ingredient) development and manufacturing.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection in Nifuratel drug substances and products.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to ensure Nifuratel batches meet stringent pharmacopeial (e.g., USP, EP) or internal specifications for impurity limits.
• Stability Studies and Forced Degradation Testing: Acts as a marker to track the formation of specific degradation products under various stress conditions (light, heat, humidity) to establish product shelf life.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough understanding and control of the impurity profile of Nifuratel.
• Research on Synthetic Pathways: Used in chemical research to study and optimize the synthesis of Nifuratel, helping to minimize the formation of this specific impurity.

Basic Information

Product Name	Nifuratel Impurity
CAS No.	167103-07-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nifuratel Related Compound; Nifuratel Process Impurity; 5-(Methylamino)-3-[(5-nitrofurfurylidene)amino]-2-oxazolidinone (probable structure based on naming); Impurity of Nifuratel; Nifuratel Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Nifuratel Impurity (CAS 167103-07-3) is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (typically 15-25°C). For long-term storage, consider storing under inert atmosphere if the compound is found to be easily oxidized. Keep the container tightly sealed in a dry environment to protect against moisture if the material is hygroscopic.

Specification

Item	Specification
Appearance	Off-white to yellow solid powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
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)	≤ 2.0%

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