Description

n-Desmethylterbinafine is a key pharmaceutical intermediate and metabolite of the antifungal agent terbinafine. This compound is of significant importance for research and development in the pharmaceutical industry, particularly in the study of drug metabolism, pharmacokinetics, and the synthesis of novel therapeutic agents. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on antifungal drug development and bioanalytical method validation.

Application

• Pharmaceutical Intermediate: Critical for the synthesis and research of advanced antifungal agents and their derivatives.
• Metabolite Reference Standard: Used as a certified reference material in bioanalytical studies for quantifying terbinafine and its metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Research: Essential for investigating the metabolic pathways, clearance, and exposure levels of terbinafine in preclinical and clinical studies.
• Analytical Method Development: Serves as a high-purity standard for developing and validating HPLC, LC-MS, and other chromatographic assays in quality control laboratories.
• Impurity Profiling: Employed to identify, characterize, and control related substance impurities in terbinafine active pharmaceutical ingredient (API) batches.
• Academic and Institutional Research: Supports fundamental chemical and pharmacological research in universities and government institutes.

Basic Information

Product Name	n-Desmethylterbinafine
CAS No.	99473-11-7
Molecular Formula	C₂₀H₂₇N
Molecular Weight	281.44 g/mol
Synonyms	N-Desmethyl Terbinafine; Terbinafine Impurity C; (2E)-6,6-Dimethyl-2-hepten-4-yn-1-yl](2-naphthalenylmethyl)amine; N-[(1E)-6,6-Dimethylhept-1-en-4-yn-3-yl]-1-naphthalenemethanamine; Terbinafine N-Desmethyl; Terbinafine Metabolite; N-Desmethyl-terbinafine; Lamisil Metabolite
EINECS	Contact for details

Quality Control

Our n-Desmethylterbinafine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identity confirmation, purity assay, and impurity profiling via advanced techniques like HPLC and mass spectrometry. We provide a detailed Certificate of Analysis (COA) with each shipment, ensuring traceability and compliance with your research or quality specifications. For cGMP-grade material or specific pharmacopeial standards (e.g., as a reference impurity), please contact our technical sales team.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
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 impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 0.5%

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