Description

Dibucaine Impurity D is a designated impurity of the local anesthetic agent Dibucaine (Cinchocaine). This high-purity reference standard is critical for pharmaceutical research, development, and quality control processes. It is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical industry to ensure the safety, efficacy, and regulatory compliance of Dibucaine-based products through accurate identification and quantification.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments and validation of testing methods.
• Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods specifically for the analysis of Dibucaine and its related substances.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control the levels of Dibucaine Impurity D in active pharmaceutical ingredients (APIs) and finished drug products, ensuring they meet pharmacopeial limits (e.g., USP, EP).
• Stability Studies: Employed to identify and quantify degradation products that may form in Dibucaine formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings with agencies like the FDA, EMA, and other global health authorities.
• Research on Degradation Pathways: Aids in understanding the chemical stability and degradation mechanisms of Dibucaine.

Basic Information

Product Name	Dibucaine Impurity D
CAS No.	10222-61-4
Molecular Formula	C20H29N3O2
Molecular Weight	343.47 g/mol
Synonyms	2-Butoxy-N-[2-(diethylamino)ethyl]-4-quinolinecarboxamide; Cinchocaine Impurity D; Dibucaine Related Compound D; 4-Aminobenzoic Acid, 2-Butoxy-, 2-(Diethylamino)ethyl Ester (quinoline derivative); 2-Butoxy-4-quinolinecarboxylic acid 2-(diethylamino)ethyl amide
EINECS	Contact for details

Quality Control

Every batch of Dibucaine Impurity D is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. 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 prevent potential oxidation.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.