Description

Butenafine Impurity 15 is a designated impurity standard of the antifungal active pharmaceutical ingredient Butenafine Hydrochloride. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations during research, development, and quality control processes. It is primarily required by analytical laboratories and pharmaceutical manufacturers for method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Butenafine Impurity 15 in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC, GC) to monitor impurity profiles.
• Stability Testing & Forced Degradation Studies: Employed to identify and track degradation products formed under various stress conditions (heat, light, humidity).
• Quality Control & Batch Release: Serves as a system suitability standard in routine QC testing to ensure product consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMF), investigational new drug (IND), and new drug application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to understand impurity formation pathways and to optimize manufacturing processes.

Basic Information

Product Name	Butenafine Impurity 15
CAS No.	124830-38-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Butenafine Related Compound; Butenafine EP Impurity; Butenafine USP Impurity; Butenafine Hydrochloride Impurity 15; Butenafine Process Impurity; N-[[4-(1,1-Dimethylethyl)phenyl]methyl]-N-methyl-1-naphthalenemethanamine Impurity; (Z)-But-2-enedioic acid compound impurity
EINECS	Contact for details

Quality Control

Every batch of Butenafine Impurity 15 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, GC-MS, and NMR to ensure they meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines (USP, EP, ICH).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The container should be kept securely sealed to prevent moisture absorption 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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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