Description

Dyclonine Impurity 3 CAS NO 14146-86-2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of Dyclonine, a local anesthetic, by serving as a benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical quality control laboratories, research institutions, and manufacturers involved in the development and production of Dyclonine and related pharmaceutical products.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Dyclonine Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods for Dyclonine analysis.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Dyclonine under various environmental conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control and characterization of the drug substance.
• Research & Development: Utilized in synthetic chemistry research to study the formation, structure, and properties of Dyclonine-related compounds.

Basic Information

Product Name	Dyclonine Impurity 3
CAS No.	14146-86-2
Molecular Formula	C18H27NO2
Molecular Weight	289.41 g/mol
Synonyms	1-(4-Butoxyphenyl)-3-(1-piperidinyl)-1-propanone; 4'-Butoxy-3-piperidinopropiophenone; Dyclonine Related Compound; Dyclonine EP Impurity C; Dyclonine USP Impurity; β-Piperidino-4'-butoxypropiophenone
EINECS	Contact for details

Quality Control

Every batch of Dyclonine Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, GC, NMR, and Mass Spectrometry to ensure they meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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