Description

Terbinafine Dimer Impurity is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of the dimeric impurity formed during the synthesis or storage of the antifungal drug Terbinafine HCl. It is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical industry to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for method development and validation in HPLC and LC-MS analysis of Terbinafine HCl.
• Impurity Profiling and Control: Used to establish specification limits and monitor levels of the dimer impurity in active pharmaceutical ingredient (API) batches to meet ICH Q3A/B guidelines.
• Stability Studies: Employed in forced degradation and long-term stability testing of Terbinafine formulations to track impurity formation over time.
• Regulatory Submissions: Critical for preparing impurity data packages required for drug master files (DMFs), ANDAs, and other regulatory filings with agencies like the FDA and EMA.
• Quality Control Laboratories: Used as a system suitability standard and for routine quality control testing of Terbinafine API and finished drug products.
• Academic and Contract Research: Supports research into the degradation pathways, pharmacokinetics, and metabolic profile of Terbinafine and related compounds.

Basic Information

Item	Details
Product Name	Terbinafine Dimer Impurity
CAS No.	934365-23-8
Molecular Formula	C42H58N2
Molecular Weight	590.93 g/mol
Synonyms	Terbinafine Dimer; Terbinafine Dimer Impurity; Terbinafine Related Compound D; (2E)-N,6,6-Trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine Dimer; Lamisil Dimer Impurity; SF 86-327 Dimer; Allylamine Dimer Impurity
EINECS	Contact for details

Quality Control

Our Terbinafine Dimer Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation by techniques such as IR and NMR spectroscopy, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

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.