Description

Naftifine Impurity 8 is a high-purity chemical reference standard, identified by CAS NO 98978-29-1, used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antifungal active pharmaceutical ingredient (API) Naftifine. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, impurity profiling, and stability studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of a specific impurity in Naftifine API and its formulations.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or GC methods for quality control laboratories.
• Stability Studies: Employed to monitor the formation of this impurity during forced degradation and long-term stability testing of drug products.
• Regulatory Compliance & Documentation: Provides essential data for regulatory filings (e.g., ANDA, NDA) to meet FDA, ICH, and other global health authority requirements.
• Chemical Research: Used as a building block or intermediate in synthetic organic chemistry research related to allylamine antifungals.
• Quality Control & Assurance: Acts as a primary standard for in-house calibration and routine quality control testing to ensure batch-to-batch consistency.

Basic Information

Product Name	Naftifine Impurity 8
CAS No.	98978-29-1
Molecular Formula	C21H21N
Molecular Weight	287.40 g/mol
Synonyms	(E)-N-Cinnamyl-N-methyl-1-naphthalenemethylamine; (E)-N-Methyl-N-((1-naphthyl)methyl)-3-phenyl-2-propen-1-amine; Naftifine Related Compound; Naftifine EP Impurity; Naftifine USP Impurity; Allylamine Impurity; N-Methyl-N-(1-naphthylmethyl)cinnamylamine
EINECS	Contact for details

Quality Control

Every batch of Naftifine Impurity 8 (CAS 98978-29-1) is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, GC, NMR, and MS, to ensure high purity and accurate identification, meeting the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) with detailed chromatographic data are provided and can be tailored to support specific pharmacopeial standards (USP, EP, ICH).

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.

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 individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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