Description

Butenafine Impurity 13 is a designated chemical reference standard used in the pharmaceutical development and quality control of the antifungal agent Butenafine. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a known impurity for analytical method validation and stability studies. It is an essential material for analytical laboratories, quality assurance departments, and research institutions within the global pharmaceutical and fine chemical sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Butenafine-related impurities in compliance with ICH guidelines.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and GC methods to monitor impurity profiles during API synthesis and formulation.
• Quality Control & Batch Release: Used in routine QC testing to ensure Butenafine API and finished drug products meet stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (light, heat, humidity) to establish product shelf life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Supports synthetic route optimization and impurity fate and tolerance studies during process chemistry development.

Basic Information

Product Name	Butenafine Impurity 13
CAS No.	101846-86-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Butenafine Related Compound; Butenafine EP Impurity; Butenafine USP Impurity; Butenafine Process Impurity; N-Benzyl-N-(4-tert-butylbenzyl)amine Related Compound; (4-tert-Butylphenyl)methanamine Impurity; Butenafine Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Butenafine Impurity 13 is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, well-ventilated area. Keep the container sealed to protect from moisture and contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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