Description

Butenafine Impurity 19 is a designated impurity standard used in the analytical profiling and quality control of the antifungal active pharmaceutical ingredient (API) Butenafine. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Butenafine Impurity 19 in Butenafine Hydrochloride API and finished drug products.
• Analytical Method Development & Validation (HPLC/GC): Essential for developing, optimizing, and validating stability-indicating analytical methods as per ICH guidelines.
• Quality Control & Batch Release: Used in routine quality control laboratories to monitor impurity levels and ensure compliance with pharmacopoeial specifications (e.g., USP, EP).
• 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 demonstrate comprehensive impurity profiling and control strategies.
• Research & Development: Used in R&D to understand the degradation pathways and synthesis by-products of Butenafine.

Basic Information

Product Name	Butenafine Impurity 19
CAS No.	110951-99-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Butenafine Related Compound 19; Butenafine EP Impurity 19; Butenafine USP Impurity 19; Butenafine Process Impurity; N-[[4-(1,1-Dimethylethyl)phenyl]methyl]-N-methyl-1-naphthalenemethanamine Impurity 19; (Z)-But-2-ene Impurity of Butenafine; Butenafine Degradation Product
EINECS	Contact for details

Quality Control

Our Butenafine Impurity 19 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for every lot, supporting compliance with cGMP and ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% 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.