Description

Terbinafine Ep Impurity E Dihcl is a high-purity chemical reference standard, specifically identified as an impurity of the antifungal drug Terbinafine Hydrochloride. This compound is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of impurities to ensure drug safety and efficacy. It is primarily utilized by analytical laboratories, quality control units, and R&D departments within the pharmaceutical and fine chemical industries for method validation and regulatory compliance purposes.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analysis of Terbinafine Hydrochloride active pharmaceutical ingredient (API) and finished drug products.
• Method Development and Validation: Used in developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques, for impurity profiling.
• Quality Control and Assurance: Essential for routine quality control testing to monitor and control the level of this specific impurity, ensuring batches meet pharmacopeial specifications (e.g., EP, USP).
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity identification and qualification as per ICH guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies of Terbinafine formulations to track impurity formation over time.
• Research and Development: Used in synthetic chemistry research to study degradation pathways and to synthesize and purify Terbinafine and related compounds.

Basic Information

Product Name	Terbinafine Ep Impurity E Dihcl
CAS No.	863984-04-7
Molecular Formula	C21H26Cl2N
Molecular Weight	363.35 g/mol
Synonyms	Terbinafine Impurity E Dihydrochloride; (E)-N-(6,6-Dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine Dihydrochloride; Terbinafine EP Impurity E; Terbinafine Related Compound E; (E)-N-Methyl-N-(6,6-dimethylhept-2-en-4-ynyl)-1-naphthylmethylamine Dihydrochloride; Terbinafine Dihydrochloride Impurity E; Terbinafine HCl Impurity E
EINECS	Contact for details

Quality Control

Every batch of Terbinafine Ep Impurity E Dihcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA), detailing purity, identity, and impurity profile, is provided with each shipment to support your quality assurance and regulatory needs.

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) and must be kept under dry, inert conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.