Description

Dyclonine Impurity 1 is a specified impurity of the local anesthetic Dyclonine, identified by CAS No. 95605-38-2. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require reliable materials for ensuring drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Dyclonine Impurity 1 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Used to track the formation and growth of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Facilitates studies on the synthesis pathway, degradation mechanisms, and toxicological profile of Dyclonine-related compounds.

Basic Information

Product Name	Dyclonine Impurity 1
CAS No.	95605-38-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dyclonine Related Compound; 1-(4-Butoxyphenyl)-3-(1-piperidinyl)-1-propanone; Dyclonine EP Impurity; Dyclonine USP Impurity; Dyclonine Process Impurity; Dyclonine Degradant; Dyclonine Specified Impurity
EINECS	Contact for details

Quality Control

Our Dyclonine Impurity 1 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including chromatographic purity and identity confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided, detailing the results for identity, assay, purity, and related substances. Our quality commitment aligns with cGMP principles to support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

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)	Individual unknown impurity: ≤ 0.5% 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.