Description

Butenafine Impurity 4 is a specified impurity and reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Butenafine. This compound is critical for ensuring the purity, safety, and efficacy of antifungal drug formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Butenafine Impurity 4 in Butenafine API and finished drug products.
• Analytical Method Development & Validation (HPLC/GC): Essential for developing and validating stability-indicating chromatographic methods to monitor impurity profiles.
• Quality Control & Batch Release: Serves as a critical quality attribute (CQA) marker in the routine QC testing of pharmaceutical raw materials and finished products to ensure compliance with ICH guidelines.
• Stability Studies: Employed to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Butenafine formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to establish impurity limits and control strategies as per ICH Q3A/B requirements.
• Research & Development: Used in R&D to study the degradation pathways and chemistry of Butenafine, aiding in process optimization and impurity control.

Basic Information

Product Name	Butenafine Impurity 4
CAS No.	101827-53-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Butenafine Related Compound 4; Butenafine EP Impurity 4; Butenafine USP Impurity 4; Butenafine Process Impurity; N-[[4-(1,1-Dimethylethyl)phenyl]methyl]-N-methyl-1-naphthalenemethanamine Impurity; (Z)-But-2-enedioic acid Impurity of Butenafine; Butenafine Maleate Impurity 4
EINECS	Contact for details

Quality Control

Our Butenafine Impurity 4 is manufactured and handled under strict quality management systems. Each batch is characterized and tested using advanced analytical techniques (including HPLC, GC-MS, and NMR) to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile. Our quality standards align with ICH guidelines and support compliance in regulated pharmaceutical markets.

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 and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies
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.