Description

Terbinafine Ep Impurity C is a high-purity reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity for the antifungal drug Terbinafine, enabling precise analytical method development and validation. It is essential for quality control laboratories and pharmaceutical manufacturers to ensure product safety, efficacy, and regulatory compliance. This impurity standard supports critical work in drug substance characterization and stability studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Terbinafine-related impurities.
• Analytical Method Development: Used to develop, validate, and verify HPLC, UPLC, and other chromatographic methods for Terbinafine API and finished products.
• Quality Control & Assurance: Critical for routine batch testing in pharmaceutical QC labs to monitor impurity profiles and ensure specifications are met per ICH guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and CMC sections.
• Stability Studies: Employed in forced degradation and long-term stability studies of Terbinafine to understand degradation pathways and establish shelf-life.
• Research & Development: Used by R&D scientists for impurity profiling, synthesis pathway optimization, and process-related impurity studies.

Basic Information

Product Name	Terbinafine Ep Impurity C
CAS No.	187540-01-8
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 Impurity C; Terbinafine Related Compound C; (E)-N-Methyl-N-(6,6-dimethyl-2-hepten-4-ynyl)-1-naphthalenemethylamine; Terbinafine EP Impurity C; Terbinafine USP Impurity C; Terbinafine Process Impurity C
EINECS	Contact for details

Quality Control

Our Terbinafine Ep Impurity C is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis, to ensure compliance with pharmacopeial standards (EP, USP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against predefined specifications. We support regulatory needs with full traceability and documentation.

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); 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 corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.