Description

Terbinafine Impurity 1 Hcl is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antifungal drug Terbinafine by serving as a key marker for impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control units, and regulatory bodies focused on compliance and drug substance characterization.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Terbinafine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating chromatographic methods (HPLC, UPLC) to ensure accurate impurity detection limits.
• Quality Control & Assurance: Used in routine batch testing within pharmaceutical manufacturing to monitor and control impurity levels, ensuring compliance with pharmacopeial specifications (USP, EP).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation of degradation products in Terbinafine formulations under various stress conditions (heat, light, humidity).
• Research & Synthesis: Serves as a building block or intermediate in chemical synthesis research aimed at developing new analogs or studying metabolic pathways.

Basic Information

Item	Detail
Product Name	Terbinafine Impurity 1 Hcl
CAS No.	134274-89-8
Molecular Formula	C21H26ClN·HCl
Molecular Weight	368.36 g/mol (Free base: 327.90 g/mol)
Synonyms	(E)-N-(6,6-Dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine Hydrochloride; Terbinafine Related Compound A HCl; (E)-N-(6,6-Dimethylhept-2-en-4-yn-1-yl)-N-methyl-1-naphthamidine Hydrochloride; Terbinafine EP Impurity A HCl; Terbinafine USP Impurity A HCl; (E)-N-Methyl-N-(6,6-dimethyl-2-hepten-4-ynyl)-1-naphthalenemethanamine Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Terbinafine Impurity 1 Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with relevant pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC, NMR, and other spectroscopic analyses.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, cool place. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Single Unknown Impurity	≤ 0.5%
Total Impurities	≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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