Description

Dyclonine Impurity 2 CAS NO 66536-15-0 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development. This compound is critical for ensuring the safety and efficacy of Dyclonine, a local anesthetic, by enabling the accurate identification and quantification of process-related impurities. It is an essential material for research and development laboratories, quality assurance departments, and regulatory affairs teams within the pharmaceutical and fine chemical industries who require reliable standards for method validation and compliance testing.

Application

• Pharmaceutical Impurity Profiling: Primary use as a certified reference standard for the identification and quantification of Dyclonine Impurity 2 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to monitor impurity levels and ensure Dyclonine API meets stringent pharmacopeial specifications (e.g., ICH Q3A/B).
• Regulatory Compliance & Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of Dyclonine formulations to track impurity formation over time.
• Research & Development: Utilized in synthetic chemistry R&D to understand and optimize the Dyclonine manufacturing process to minimize this specific impurity.

Basic Information

Product Name	Dyclonine Impurity 2
CAS No.	66536-15-0
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 B; Dyclonine EP Impurity B; Dyclonine USP Impurity; β-Piperidino-4'-butoxypropiophenone; Dyclonine Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Dyclonine Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability information.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, well-ventilated area. Keep the container sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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