Description

Butenafine Impurity 7 is a specified impurity of the antifungal active pharmaceutical ingredient (API) Butenafine Hydrochloride. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development and validation. It is primarily used by quality control laboratories and regulatory affairs departments to ensure the purity, safety, and efficacy of Butenafine-based drug products. The availability of this well-characterized impurity is essential for meeting stringent global regulatory requirements for pharmaceutical manufacturing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Butenafine Impurity 7 in drug substances and finished products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions.
• Pharmacopoeial Testing: Aids in testing to meet the specifications of pharmacopoeias like USP, EP, or JP.
• Process Chemistry Research: Helps in understanding and controlling the formation of this impurity during the API synthesis process.

Basic Information

Item	Detail
Product Name	Butenafine Impurity 7
CAS No.	153357-88-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Butenafine Related Compound 7; Butenafine EP Impurity 7; Butenafine USP Impurity 7; Butenafine Hydrochloride Impurity 7; N-Methyl-N-(4-tert-butylbenzyl)-1-naphthalenemethanamine; (4-(tert-Butyl)phenyl)(naphthalen-1-yl)methyl(methyl)amine; Butenafine Impurity C (Potential designation)
EINECS	Contact for details

Quality Control

Every batch of Butenafine Impurity 7 is manufactured and handled under strict quality management systems. The product undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related impurities. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with our stringent internal specifications and relevant regulatory expectations. Our quality commitment ensures the material's suitability for its intended use as a high-grade reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature, typically between 15-25°C (59-77°F). The container should be kept in a dry, well-ventilated area. For long-term storage, consider conditions that minimize exposure to temperature fluctuations and humidity.

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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.