Description

Butenafine Impurity 3 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 reference material (CRM) for the identification and quantification of Butenafine Impurity 3 in API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Employed in routine QC testing to confirm that Butenafine API and formulations meet stringent pharmacopeial (USP, EP) and internal purity specifications.
• Stability Studies: Used to track the formation of this specific degradation product during forced degradation and long-term stability studies of Butenafine.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Butenafine Impurity 3
CAS No.	122152-13-0
Molecular Formula	C23H31N
Molecular Weight	321.50 g/mol
Synonyms	N-Butyl-N-methyl-1-naphthalenemethanamine; N-Methyl-N-(1-naphthylmethyl)-1-butanamine; N-Methyl-N-(naphthalen-1-ylmethyl)butan-1-amine; Butenafine Related Compound C; Butenafine EP Impurity C; Butenafine USP Related Compound C
EINECS	Contact for details

Quality Control

Our Butenafine Impurity 3 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, GC, NMR, and MS to confirm identity and purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality standards are designed to support compliance with cGMP, ICH guidelines, and major pharmacopeias (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference retention time
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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