Description

Terbinafine Ep Impurity F Hcl is a high-purity chemical reference standard, specifically identified as an impurity of the antifungal pharmaceutical agent Terbinafine Hydrochloride. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing and research. It is primarily used by analytical chemists, quality assurance professionals, and researchers in the pharmaceutical and biotechnology industries to ensure the purity, safety, and efficacy of Terbinafine-based drug products.

Application

• Primary use as a certified reference standard for the identification and quantification of Terbinafine-related impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Essential for pharmaceutical research and development, supporting analytical method development (HPLC, UPLC, LC-MS) and validation studies.
• Critical component in quality control (QC) and quality assurance (QA) laboratories to monitor impurity profiles and ensure batch-to-batch consistency.
• Used in regulatory compliance and submission activities, providing necessary data for ICH guidelines (Q3A, Q3B) and filings with agencies like the FDA and EMA.
• Supports stability studies to track the formation of degradation products in Terbinafine formulations over time.
• Valuable for academic and contract research organizations (CROs) conducting pharmacokinetic, metabolic, and toxicological studies.

Basic Information

Product Name	Terbinafine Ep Impurity F Hcl
CAS No.	926281-74-5
Molecular Formula	C21H26ClN • HCl
Molecular Weight	364.35 g/mol (as hydrochloride salt)
Synonyms	(E)-N-(6,6-Dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine Hydrochloride; Terbinafine Impurity F HCl; Terbinafine Related Compound F Hydrochloride; (E)-N-Methyl-N-(6,6-dimethyl-2-hepten-4-ynyl)-1-naphthalenemethanamine Hydrochloride; Terbinafine EP Impurity F; Terbinafine Hydrochloride Impurity F
EINECS	Contact for details

Quality Control

Every batch of Terbinafine Ep Impurity F Hcl is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and mass spectrometry, to ensure identity, purity, and conformity to the highest standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and specifications. We support compliance with ICH, USP, and EP guidelines for pharmaceutical impurities.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
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 unknown impurity ≤ 0.5%
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.