Description

Nifursol Impurity CAS NO 851368-01-9 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 pharmaceutical products and veterinary medicines. It is primarily required by analytical chemists, quality control laboratories, and research institutions involved in method development and validation. The availability of a well-characterized impurity standard is essential for accurate chromatographic analysis and maintaining stringent quality assurance protocols.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Nifursol drug substances and finished products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles in compliance with ICH Q3A/B guidelines.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to ensure the accuracy and precision of analytical procedures.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of related substances in pharmaceutical formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate control over the manufacturing process and product purity.
• Research & Development: Used in academic and industrial R&D to study the degradation pathways, metabolism, and chemical behavior of Nifursol.

Basic Information

Product Name	Nifursol Impurity
CAS No.	851368-01-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nifursol Related Compound; Nifursol Impurity Standard; 3,5-Dinitrosalicylic acid (4-nitrofurfurylidene)hydrazide impurity; 5-Nitro-2-furaldehyde (3,5-dinitrosalicyloyl)hydrazone; Nifursol Process Impurity; Nifursol Degradant; Nifursol Specified Impurity
EINECS	Contact for details

Quality Control

Our Nifursol Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assessment and structural confirmation, to ensure it meets the high standards required for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and assay. We support compliance with ICH, USP, and EP guidelines for impurity 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). The 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	Yellow to orange powder
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0%
Total Impurities	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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