Description

Butenafine Impurity 13 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antifungal active pharmaceutical ingredient (API) Butenafine. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies for method development, validation, and impurity profiling.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Butenafine API.
• Analytical Method Development and Validation in quality control (QC) and research and development (R&D) laboratories.
• Stability Studies to monitor impurity profiles in Butenafine formulations under various storage conditions.
• Regulatory Compliance and Documentation, supporting submissions to agencies like the FDA and EMA.
• Pharmacopoeial Testing, potentially for inclusion in monographs of standards like USP or EP.
• Research on Degradation Pathways to understand the stability and breakdown products of Butenafine.

Basic Information

Item	Detail
Product Name	Butenafine Impurity 13
CAS No.	110931-65-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Butenafine Related Compound 13; Butenafine Impurity; Butenafine EP Impurity 13; Butenafine USP Impurity 13; Butenafine Process Impurity; Butenafine Degradant; (E)-N-(4-tert-Butylbenzyl)-N-methyl-1-naphthalenemethanamine (Related Structure)
EINECS	Contact for details

Quality Control

Every batch of Butenafine Impurity 13 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, to ensure high purity and accurate identification, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and chromatographic data is provided with each shipment.

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.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%

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