Description

Niflumic Acid Impurity B is a specified impurity and analytical reference standard used in the pharmaceutical development and quality control of the non-steroidal anti-inflammatory drug (NSAID) Niflumic Acid. Its precise characterization is critical for ensuring drug safety, efficacy, and regulatory compliance by monitoring and controlling impurity profiles. This high-purity compound is essential for pharmaceutical manufacturers, analytical laboratories, and research institutions involved in API synthesis, method validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Niflumic Acid Impurity B in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or GC methods to accurately profile impurities in Niflumic Acid.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to ensure API purity meets pharmacopeial standards (e.g., USP, EP, ICH Q3A/B guidelines).
• Stability Studies: Employed to monitor the formation of degradation products in Niflumic Acid drug substances and products under various storage conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports synthetic route optimization and impurity fate and tolerance studies during process development.

Basic Information

Product Name	Niflumic Acid Impurity B
CAS No.	72633-64-8
Molecular Formula	C13H9F3N2O2
Molecular Weight	282.22 g/mol
Synonyms	2-[[3-(Trifluoromethyl)phenyl]amino]nicotinic acid; 2-((3-(Trifluoromethyl)phenyl)amino)pyridine-3-carboxylic acid; Niflumic Acid Related Compound B; Niflumic Acid EP Impurity B; Niflumic Acid USP Impurity B; 3-Pyridinecarboxylic acid, 2-[[3-(trifluoromethyl)phenyl]amino]-
EINECS	Contact for details

Quality Control

Every batch of Niflumic Acid Impurity B is manufactured under strict quality management systems and undergoes comprehensive analytical testing to ensure identity, purity, and consistency. Our products are characterized using advanced techniques including HPLC, GC-MS, NMR, and IR spectroscopy. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with ICH guidelines for impurities. Custom synthesis and purification to meet specific pharmacopeial (USP/EP) or client requirements are available.

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 desiccation.

Specification

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

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