Description

n-Desmethyl Terbinafine-D7 is a high-purity, deuterium-labeled internal standard critical for accurate quantitative analysis in bioanalytical and pharmacokinetic studies. This stable isotope-labeled compound is essential for ensuring precision and reliability in mass spectrometry-based assays, particularly for minimizing matrix effects and correcting for analyte loss. It is primarily used by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical chemists involved in drug metabolism and bioequivalence studies for the antifungal agent terbinafine.

Application

• Internal Standard for LC-MS/MS: Serves as a critical reference compound for the precise quantification of terbinafine and its metabolites in complex biological matrices like plasma, serum, and tissue homogenates.
• Pharmacokinetic & Bioanalytical Research: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical studies.
• Drug Metabolism Studies: Used to investigate the metabolic pathways and clearance mechanisms of terbinafine, aiding in the understanding of its efficacy and safety profile.
• Forensic & Doping Control Analysis: Supports highly specific and confirmatory testing for terbinafine in forensic toxicology and anti-doping laboratories.
• Method Development & Validation: A key component in developing, optimizing, and validating robust, regulatory-compliant analytical methods (e.g., following FDA/EMA guidelines).
• Quality Control in Pharmaceutical Manufacturing: Can be utilized in impurity profiling and stability-indicating assays for terbinafine-based drug products.

Basic Information

Product Name	n-Desmethyl Terbinafine-D7
CAS No.	1246833-28-2
Molecular Formula	C₂₁H₂₅D₇N
Molecular Weight	~ 304.55 g/mol
Synonyms	Terbinafine N-Desmethyl-D7; (2E)-N-[6,6,7,7,8,8,8-Heptadeuterio-6,6-dimethyl-2-hepten-4-yn-1-yl]-N-methyl-1-naphthalenemethanamine; Terbinafine Desmethyl D7; Terbinafine-d7 (N-Desmethyl); Terbinafine Metabolite Standard-D7; Lamisil Metabolite-D7; Deuterated Terbinafine Internal Standard
EINECS	Contact for details

Quality Control

Our n-Desmethyl Terbinafine-D7 is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing parameters such as assay (by HPLC), isotopic enrichment (by MS), and chemical purity. We adhere to relevant industry standards for reference materials to support your regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below for long-term stability. This compound is hygroscopic (moisture-sensitive); ensure the container is sealed under an inert atmosphere after each use to prevent degradation. Allow the vial to equilibrate to room temperature in a desiccator before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D7)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Meets ICH guidelines

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