Description

Nifuratel Impurity 5 CAS NO 34143-33-4 is a specified impurity reference standard used in the analytical profiling and quality control of the pharmaceutical compound Nifuratel. This high-purity chemical is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard for the identification and quantification of Nifuratel impurities in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Method Development and Validation in analytical chemistry, particularly for HPLC, UPLC, and LC-MS techniques.
• Quality Control (QC) and Quality Assurance (QA) testing to ensure batch-to-batch consistency and compliance with pharmacopeial limits (e.g., ICH Q3A/B guidelines).
• Stability Studies to monitor impurity profiles and degradation pathways of Nifuratel under various storage conditions.
• Regulatory Submissions, providing essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development of Nifuratel synthesis processes, aiding in route optimization and impurity fate mapping.

Basic Information

Product Name	Nifuratel Impurity 5
CAS No.	34143-33-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nifuratel Related Compound 5; Nifuratel Impurity C; 5-Nitrofuran Impurity; 34143-33-4; Nifuratel EP Impurity 5; Nifuratel USP Impurity; Nifuratel Process Impurity; Methyl 5-[(methylthio)methyl]-3-[(5-nitrofurfurylidene)amino]-2-oxazolidinone (probable structure based on class)
EINECS	Contact for details

Quality Control

Our Nifuratel Impurity 5 is manufactured under strict quality systems to meet the exacting standards of pharmaceutical impurity analysis. Each batch is characterized and tested using advanced spectroscopic and chromatographic techniques to ensure high purity and accurate identification. Comprehensive Certificates of Analysis (COA) are provided, detailing results for identity, purity, and related substances. Our quality commitment aligns with ICH guidelines and relevant pharmacopeial expectations for reference standards.

Storage

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

Specification

Item	Specification
Appearance	Off-white to yellow powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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