Description

Terbinafine Impurity 2 CAS NO 704909-67-1 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety and efficacy of the antifungal drug Terbinafine by enabling the accurate identification and quantification of related substances. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality assurance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Terbinafine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control (QC) Testing: Serves as a system suitability standard and for routine batch release testing in pharmaceutical QC laboratories to ensure compliance with ICH guidelines.
• Stability Studies: Employed to monitor the formation of degradation products in Terbinafine formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and demonstrate control strategies.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways and impurity formation mechanisms of Terbinafine.

Basic Information

Product Name	Terbinafine Impurity 2
CAS No.	704909-67-1
Molecular Formula	C21H25N
Molecular Weight	291.43 g/mol
Synonyms	(E)-N-(6,6-Dimethylhept-2-en-4-yn-1-yl)-N-methyl-1-naphthalenemethanamine; Terbinafine Naphthalene Impurity; Terbinafine Related Compound 2; (E)-N-Methyl-N-(6,6-dimethyl-2-hepten-4-ynyl)-1-naphthalenemethylamine; 1-Naphthalenemethanamine, N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-, (2E)-
EINECS	Contact for details

Quality Control

Our Terbinafine Impurity 2 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, residual solvent analysis (GC), and structural confirmation (NMR, MS) to ensure identity and purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against predefined specifications. Our quality commitment aligns with ICH Q3A/B guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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