Description

Dyclonine Impurity 6 is a specified impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient Dyclonine. This compound is critical for pharmaceutical quality control and regulatory compliance, ensuring the purity and safety of Dyclonine-based products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Dyclonine Impurity 6 in Dyclonine HCl and related drug substances.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods in accordance with ICH guidelines.
• Quality Control & Batch Release: Serves as a system suitability standard and for preparing calibration curves to determine impurity levels in commercial Dyclonine batches.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing impurity characterization data and setting appropriate specification limits.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Used in synthetic chemistry R&D to understand and control impurity formation pathways during the manufacturing process of Dyclonine.

Basic Information

Product Name	Dyclonine Impurity 6
CAS No.	80840-88-6
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; Dyclonine Process Impurity; 4'-Butoxy-3-piperidinopropiophenone; Dyclonine Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Dyclonine Impurity 6 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive identity, purity, and impurity profile testing using validated analytical methods such as HPLC, GC, NMR, and Mass Spectrometry. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications and relevant pharmacopeial standards (USP/EP). Our quality commitment ensures the reliability and traceability required for GMP and regulatory applications.

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 under dry, inert conditions to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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