Description

Naftifine Impurity 9 is a specified impurity and reference standard used in the analytical profiling and quality control of the antifungal active pharmaceutical ingredient, Naftifine. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the development, production, and regulatory compliance of Naftifine-based products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Naftifine API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine quality control testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Naftifine.

Basic Information

Item	Details
Product Name	Naftifine Impurity 9
CAS No.	98978-36-0
Molecular Formula	C21H21N
Molecular Weight	287.40 g/mol
Synonyms	(E)-N-Cinnamyl-N-methyl-1-naphthalenemethanamine; (E)-N-Methyl-N-(3-phenyl-2-propen-1-yl)-1-naphthalenemethanamine; Naftifine N-Oxide Impurity; Naftifine Related Compound; Naftifine EP Impurity; Naftifine USP Impurity; N-Methyl-N-(cinnamyl)-1-naphthalenemethylamine
EINECS	Contact for details

Quality Control

Every batch of Naftifine Impurity 9 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Our quality system is designed to meet the stringent requirements of pharmaceutical reference standard users. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters, ensuring full traceability and compliance with relevant pharmacopeial (USP, EP) and ICH guidelines.

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 should be handled 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 structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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