Description

Flunixin Meglumine Impurity 4 (Flunixin Meglumine EP Impurity D) is a specified impurity used as a critical reference standard in the pharmaceutical quality control process. This compound is essential for ensuring the purity, safety, and efficacy of the non-steroidal anti-inflammatory drug (NSAID) Flunixin Meglumine, primarily used in veterinary medicine. It is a vital material for analytical laboratories, research institutions, and manufacturers engaged in method development, validation, and regulatory compliance testing. The product is supplied with comprehensive analytical data to support stringent quality assurance protocols.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, LC-MS, and other chromatographic methods in pharmacopeial testing.
• Analytical Method Development & Validation (AMV): Critical for developing and validating stability-indicating assay methods for Flunixin Meglumine API and finished dosage forms.
• Quality Control & Assurance (QC/QA): Used for identification, qualification, and quantification of this specific impurity in batch release testing to meet ICH guidelines.
• Regulatory Compliance & Submission: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity profiles and control strategies.
• Stability Studies: Employed to monitor the formation of degradation products in forced degradation and long-term stability studies of Flunixin Meglumine.
• Research & Development: Used in synthetic chemistry and pharmaceutical R&D for studying impurity formation pathways and purification processes.

Basic Information

Item	Detail
Product Name	Flunixin Meglumine Impurity 4 (Flunixin Meglumine EP Impurity D)
CAS No.	54396-42-8
Molecular Formula	C21H28FN3O9
Molecular Weight	485.46 g/mol
Synonyms	Flunixin EP Impurity D; Flunixin Impurity 4; Flunixin Related Compound D; 2-[[2-Methyl-3-(trifluoromethyl)phenyl]amino]-3-pyridinecarboxylic acid compound with 1-deoxy-1-(methylamino)-D-glucitol (1:1); Flunixin Meglumine Impurity D; Flunixin Meglumine Related Substance D; Banamine Impurity D; (2-((2-Methyl-3-(trifluoromethyl)phenyl)amino)nicotinic acid) - (1-deoxy-1-(methylamino)-D-glucitol) (1:1)
EINECS	Contact for details

Quality Control

Every batch of Flunixin Meglumine Impurity 4 is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and conformity to its specification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the standards required for pharmaceutical reference materials, supporting compliance with ICH Q3A/B, USP, and EP guidelines.

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 absorption of moisture. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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