Description

Fluralaner Impurity 5 is a specified impurity and reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Fluralaner. This compound is critical for ensuring the purity, safety, and efficacy of veterinary pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Fluralaner API.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and identification standard in the routine batch testing of Fluralaner to ensure compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new animal drug applications (NADAs).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Research & Development: Used in synthetic chemistry R&D for route scouting and process optimization to minimize impurity formation.

Basic Information

Product Name	Fluralaner Impurity 5
CAS No.	2382920-54-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fluralaner Related Compound 5; Fluralaner Specified Impurity 5; 4-[5-(3,5-Dichlorophenyl)-5-(trifluoromethyl)-4,5-dihydro-1,2-oxazol-3-yl]-2-methyl-N-[3-(methylsulfonyl)propyl]benzamide Impurity; BRAVECTO Impurity 5; Isoxazoline Impurity; Veterinary Drug Impurity
EINECS	Contact for details

Quality Control

Every batch of Fluralaner Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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