Description

Nifuratel Impurity 6 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the active pharmaceutical ingredient Nifuratel. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Nifuratel API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurities during manufacturing.
• Quality Assurance & Control (QA/QC): Serves as a benchmark in routine quality control testing to ensure batch-to-batch consistency and adherence to pharmacopeial limits (e.g., ICH Q3A/B).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data for drug master files (DMFs) and CMC sections.
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions and throughout shelf-life studies.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to synthesize purer batches of the main API.

Basic Information

Product Name	Nifuratel Impurity 6 Hcl
CAS No.	951781-95-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nifuratel Related Compound 6 Hydrochloride; Nifuratel Impurity 6 Hydrochloride Salt; 5-[(Methylamino)methyl]-3-[(5-nitrofurfurylidene)amino]-2-oxazolidinone Hydrochloride; Nifuratel EP Impurity 6 HCl; Nifuratel USP Impurity 6 HCl; Nifuratel Degradation Product 6 HCl
EINECS	Contact for details

Quality Control

Our Nifuratel Impurity 6 Hcl is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical impurity analysis. Each batch is characterized and tested using advanced analytical techniques such as HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing purity, assay, and impurity profile. Our quality commitment aligns with ICH guidelines and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	Off-white to light yellow solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	≥ 90.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH limits
Single Unknown Impurity (HPLC)	≤ 1.0%
Total Impurities (HPLC)	≤ 5.0%

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