Description

Terbinafine Related Compound 1 is a high-purity chemical reference standard, essential for pharmaceutical research and quality control. This compound is critical for ensuring the purity, safety, and efficacy of the antifungal drug Terbinafine and its formulations. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method development, validation, and impurity profiling. Consistent quality and reliable supply are paramount for maintaining stringent compliance in drug development and production.

Application

• Pharmaceutical Reference Standard: Used 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: A critical component in developing and validating HPLC, UPLC, or GC methods for stability-indicating assays and impurity testing.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation of degradation products in Terbinafine formulations under various stress conditions (heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Serves as a key intermediate or impurity marker in synthetic chemistry research and process optimization for Terbinafine manufacturing.

Basic Information

Product Name	Terbinafine Related Compound 1
CAS No.	98978-50-8
Molecular Formula	C21H25N
Molecular Weight	291.43 g/mol
Synonyms	(E)-N-(6,6-Dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine; (E)-N-Methyl-N-(6,6-dimethylhept-2-en-4-ynyl)-1-naphthylmethylamine; Terbinafine Impurity; Terbinafine EP Impurity; Terbinafine USP Related Compound; (E)-Terbinafine N-Oxide Decomposition Product; Allylamine Antifungal Impurity
EINECS	Contact for details

Quality Control

Our Terbinafine Related Compound 1 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical analysis. Each batch is subjected to comprehensive testing, including identity confirmation, purity assay, and impurity profile analysis via validated chromatographic methods. A Certificate of Analysis (COA) detailing all test results is provided to guarantee traceability and compliance with relevant guidelines, including ICH and pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider using desiccants.

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)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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