Description

Dyclonine Impurity 13 is a designated impurity standard of the local anesthetic Dyclonine, identified by CAS NO 28066-70-8. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical products containing Dyclonine. It is primarily required by pharmaceutical manufacturers and analytical laboratories for research, method development, and stringent quality control processes.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Dyclonine Impurity 13 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, GC, or other chromatographic methods to monitor impurities in Dyclonine-based formulations.
• Quality Control & Assurance (QC/QA): Serves as a critical benchmark in routine quality control testing to ensure Dyclonine batches meet pharmacopeial (e.g., USP, EP) or internal purity specifications.
• Stability Studies: Employed to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of Dyclonine.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and marketing applications.
• Research & Development: Utilized in R&D to understand the degradation pathways, synthesis by-products, and metabolic profile of Dyclonine.

Basic Information

Product Name	Dyclonine Impurity 13
CAS No.	28066-70-8
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; Dyclonine EP Impurity; Dyclonine USP Impurity; Dyclonine Process Impurity; β-Piperidino-4'-butoxypropiophenone
EINECS	Contact for details

Quality Control

Every batch of Dyclonine Impurity 13 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, NMR, and MS to ensure compliance with industry and regulatory standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 maintain stability.

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 guidelines

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