Description

Butenafine Impurity 11 is a specified organic compound used as a reference standard in analytical chemistry. This impurity is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Butenafine, an antifungal agent. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in method development and validation. The compound is essential for compliance with stringent regulatory guidelines governing impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Butenafine Impurity 11 in Butenafine API and finished drug products.
• Analytical Method Development: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency of Butenafine, supporting ICH Q3A/B guidelines.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization data.
• Stability Studies: Used to track the formation and level of this specific impurity during forced degradation and long-term stability studies of Butenafine formulations.
• Research & Development: Utilized in pharmaceutical R&D to study the degradation pathways and synthesis by-products of Butenafine.

Basic Information

Product Name	Butenafine Impurity 11
CAS No.	1526530-79-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Butenafine Related Compound 11; Butenafine EP Impurity 11; Butenafine USP Impurity 11; Butenafine Process Impurity; N-Benzyl-N-methyl-1-naphthalenemethanamine Impurity; (Z)-N-(4-tert-Butylbenzyl)-N-methyl-1-naphthalenemethanamine Impurity; Allylamine Antifungal Impurity
EINECS	Contact for details

Quality Control

Our Butenafine Impurity 11 is manufactured under strict quality control protocols to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each batch is characterized using advanced analytical techniques including HPLC, GC-MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile. Our quality system is designed to support compliance with cGMP and relevant pharmacopeial standards (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. 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
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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