Description

Butenafine Impurity 12 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient 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 12 in Butenafine API and finished drug products.
• Analytical Method Development & Validation (HPLC/GC): Essential for developing and validating chromatographic methods to monitor impurities during stability studies and release testing.
• Quality Control & Assurance (QC/QA): Serves as a critical tool in pharmaceutical QC laboratories to confirm product specifications and ensure compliance with ICH guidelines (Q3A, Q3B).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., DMF, CMC sections) by providing characterized impurity data for health authorities like the FDA and EMA.
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions (heat, light, humidity) over time.
• Research & Development (R&D): Used in synthetic chemistry R&D to understand and control impurity formation pathways during the manufacturing process of Butenafine.

Basic Information

Product Name	Butenafine Impurity 12
CAS No.	759458-92-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Butenafine Related Compound 12; Butenafine EP Impurity 12; Butenafine USP Impurity 12; Butenafine Process Impurity; Butenafine Specified Impurity; N-[[4-(1,1-Dimethylethyl)phenyl]methyl]-N-methyl-1-naphthalenemethanamine Impurity; (Z)-Butenafine Impurity; Allylamine Antifungal Impurity
EINECS	Contact for details

Quality Control

Our Butenafine Impurity 12 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity analysis and structural confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and assay.

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 must be kept in a desiccated environment to maintain stability and purity.

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 with specification
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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