Description

Dyclonine Impurity 8 is a designated reference standard used for the analytical profiling and quality control of the local anesthetic Dyclonine. This high-purity compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety and regulatory compliance by accurately identifying and quantifying this specific impurity. It is essential for research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Dyclonine Impurity 8 in Dyclonine HCl active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Crucial for developing, optimizing, and validating chromatographic methods (HPLC, UPLC, GC) to monitor impurities.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Dyclonine API and formulations meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions (heat, light, humidity) to establish shelf-life and storage recommendations.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive characterization data for impurity profiles.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Dyclonine, leading to improved formulation strategies.

Basic Information

Product Name	Dyclonine Impurity 8
CAS No.	61405-66-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dyclonine Related Compound 8; Dyclonine EP Impurity 8; Dyclonine USP Impurity 8; 4-Butoxy-3-piperidinopropiophenone Impurity; 1-(4-Butoxyphenyl)-3-(1-piperidinyl)-1-propanone related substance; Dyclonine Process Impurity; Dyclonine Degradant
EINECS	Contact for details

Quality Control

Our Dyclonine Impurity 8 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques such as HPLC, GC, NMR, and MS. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances and products.

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 must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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