Description

Dyclonine Impurity 5 is a specified impurity of the local anesthetic agent Dyclonine, identified by the CAS registry number 165261-15-4. This high-purity reference standard is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of impurities to ensure drug safety and efficacy. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry focused on method development, validation, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Dyclonine and related pharmaceutical formulations.
• Analytical Method Development: Crucial for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Assurance: Used in-house by manufacturers to establish impurity acceptance criteria and ensure batch-to-batch consistency of active pharmaceutical ingredients (APIs).
• Regulatory Compliance & Filing: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Serves as a key intermediate or marker in synthetic pathway studies and impurity synthesis for pharmacological evaluation.

Basic Information

Product Name	Dyclonine Impurity 5
CAS No.	165261-15-4
Molecular Formula	C18H27NO2
Molecular Weight	289.41 g/mol
Synonyms	1-(4-Butoxyphenyl)-3-(1-piperidinyl)-1-propanone; Dyclonine Related Compound; Dyclonine EP Impurity; Dyclonine USP Impurity; 4'-Butoxy-3-piperidinopropiophenone; Dyclonine Process Impurity; Dyclonine Degradant
EINECS	Contact for details

Quality Control

Every batch of Dyclonine Impurity 5 (CAS 165261-15-4) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of water vapor. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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