Description

Flubendazole Ep Impurity F is a designated impurity standard used in the pharmaceutical development and quality control of the anthelmintic drug Flubendazole. This compound is critical for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API) by serving as a reference marker in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, validation, and compliance testing of Flubendazole-based formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Flubendazole Ep Impurity F in API batches.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish system suitability, specificity, and detection limits.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing to monitor and control impurity profiles as per ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Research & Development (R&D): Used in process chemistry to understand and optimize synthesis pathways to minimize impurity formation.

Basic Information

Product Name	Flubendazole Ep Impurity F
CAS No.	132119-20-1
Molecular Formula	C16H12FN3O3
Molecular Weight	313.29 g/mol
Synonyms	Flubendazole Impurity F; Flubendazole Related Compound F; Methyl [5-(4-fluorobenzoyl)-1H-benzimidazol-2-yl]carbamate; (5-(4-Fluorobenzoyl)-1H-benzo[d]imidazol-2-yl)carbamic acid methyl ester; Flubendazole EP Impurity F; Flubendazole USP Impurity F; Flubendazole Process Impurity F
EINECS	Contact for details

Quality Control

Every batch of Flubendazole Ep Impurity F is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (IR, NMR, MS), to ensure compliance with pharmacopeial standards (EP, USP) and customer-specific requirements. 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 at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive (store away from light).

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)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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