Description

Butenafine Impurity 12 is a designated chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Butenafine Hydrochloride, an antifungal medication. It is an essential tool for pharmaceutical companies, contract research organizations (CROs), and analytical laboratories engaged in method development, validation, and regulatory compliance.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Butenafine Hydrochloride API.
• Critical component in analytical method development and validation (HPLC, GC, LC-MS) for impurity profiling.
• Essential for quality control (QC) and quality assurance (QA) processes in GMP-compliant manufacturing facilities.
• Used in stability studies to monitor degradation products and ensure drug product shelf-life.
• Serves as a calibration standard in regulatory submissions (e.g., ANDA, NDA) to meet FDA, ICH, and pharmacopoeial guidelines.
• Valuable for research and development to understand the synthesis pathway and impurity formation of Butenafine.

Basic Information

Product Name	Butenafine Impurity 12
CAS No.	191668-01-6
Molecular Formula	C23H31N
Molecular Weight	321.50 g/mol
Synonyms	N-[(4-tert-Butylphenyl)methyl]-N-methyl-1-naphthalenemethanamine; Butenafine Related Compound; Butenafine EP Impurity; Butenafine USP Impurity; Butenafine Process Impurity; (4-tert-Butylbenzyl)methyl(1-naphthylmethyl)amine; 1-Naphthalenemethanamine, N-[(4-(1,1-dimethylethyl)phenyl)methyl]-N-methyl-
EINECS	Contact for details

Quality Control

Every batch of Butenafine Impurity 12 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with pharmaceutical reference standard requirements and relevant guidelines (ICH, USP, EP). A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment to support your regulatory and research needs.

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. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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