Description

Niflumic Acid Ep Impurity F CAS NO 59361-45-4 is a high-purity chemical reference standard, specifically identified as a key impurity in the synthesis and quality control of Niflumic Acid. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical products. It is primarily required by analytical laboratories, quality assurance departments, and research institutions within the global pharmaceutical and fine chemical industries for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Niflumic Acid Ep Impurity F in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control (QC) Testing: Serves as a system suitability and calibration standard in routine QC laboratories to ensure the purity and consistency of Niflumic Acid batches.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., DMF, CMC sections) by providing a characterized impurity for specification setting and stability studies.
• Research & Development: Used in pharmaceutical R&D to study degradation pathways, impurity profiling, and to synthesize and characterize related substances.
• Contract Research Organization (CRO) Services: Supplied to CROs and testing laboratories offering outsourced analytical services to the pharmaceutical industry.

Basic Information

Product Name	Niflumic Acid Ep Impurity F
CAS No.	59361-45-4
Molecular Formula	C13H9F3N2O2
Molecular Weight	282.22 g/mol
Synonyms	2-[[3-(Trifluoromethyl)phenyl]amino]-3-pyridinecarboxylic acid; 2-({[3-(Trifluoromethyl)phenyl]amino})nicotinic acid; Niflumic Acid Impurity F; EP Impurity F of Niflumic Acid; Niflumic Acid Related Compound F; 3-Pyridinecarboxylic acid, 2-[[3-(trifluoromethyl)phenyl]amino]-; 2-[(3-Trifluoromethylphenyl)amino]nicotinic acid
EINECS	Contact for details

Quality Control

Our Niflumic Acid Ep Impurity F is manufactured and controlled under a strict quality management system. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical impurity analysis. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and regulatory support.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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