Description

Nifuratel Impurity 20 (Mixture Of Diastereomers) is a defined chemical impurity used as a critical reference standard in pharmaceutical quality control and analytical research. This compound is essential for the accurate identification, quantification, and monitoring of process-related impurities during the development and manufacturing of the active pharmaceutical ingredient Nifuratel. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) engaged in method validation and regulatory compliance activities.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for calibrating analytical instruments and validating testing methods (e.g., HPLC, LC-MS) in compliance with ICH Q3A/B guidelines.
• Method Development & Validation: Used to develop and validate stability-indicating assay methods for Nifuratel drug substance and finished products.
• Quality Control & Batch Release: Critical for establishing impurity profiles, setting specification limits, and ensuring batch-to-batch consistency of Nifuratel API.
• Regulatory Submission Support: Provides necessary data on impurity identity and levels for regulatory filings (e.g., ANDA, NDA, CMC dossiers) with agencies like the FDA and EMA.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic) as part of forced degradation studies.
• Process Chemistry Optimization: Helps synthetic chemists identify the source of this impurity in the manufacturing process, enabling route refinement and impurity minimization.

Basic Information

Product Name	Nifuratel Impurity 20 (Mixture Of Diastereomers)
CAS No.	74920-48-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nifuratel Related Compound 20; Nifuratel EP Impurity 20; Nifuratel USP Impurity 20; 5-(Methylamino)-3-[(5-nitrofurfurylidene)amino]-2-oxazolidinone (Diastereomeric Mixture); 2-Oxazolidinone, 5-(methylamino)-3-[(5-nitrofurfurylidene)amino]-, (RS)-; (RS)-5-(Methylamino)-3-[(5-nitrofurfurylidene)amino]-2-oxazolidinone
EINECS	Contact for details

Quality Control

Our Nifuratel Impurity 20 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and reliable performance as a reference material. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), and related substances. Our quality system supports compliance with current Good Manufacturing Practices (cGMP) and relevant pharmacopeial standards (e.g., USP, EP) for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	Off-white to yellow powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0% (Area Percent)
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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