Description

Dequalinium Ep Impurity B is a high-purity reference standard used for analytical and research purposes. This compound is critical for quality control and method validation in pharmaceutical development, ensuring the purity and safety of active pharmaceutical ingredients. It is primarily required by analytical laboratories, quality assurance departments, and research institutions involved in the synthesis and analysis of Dequalinium and related compounds.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for calibrating analytical instruments and validating testing methods (HPLC, GC-MS) in compliance with ICH guidelines.
• Quality Control & Assurance: Essential for the identification and quantification of process-related impurities in Dequalinium API batches to meet pharmacopeial specifications (EP, USP).
• Method Development & Validation: Serves as a critical component in developing and validating stability-indicating assay methods for drug substances and finished products.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., CMC sections for FDA, EMA) by providing definitive impurity profiling and characterization data.
• Research & Development: Utilized in metabolic studies, degradation pathway analysis, and synthetic chemistry research to understand impurity formation and control.

Basic Information

Product Name	Dequalinium Ep Impurity B
CAS No.	747387-02-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dequalinium Impurity B; Dequalinium Chloride Impurity B; 1,1'-(1,10-Decanediyl)bis(4-amino-2-methylquinolinium) Impurity B; Decamethylenebis(4-aminoquinaldinium) Impurity B; BDBQ Impurity B; Dequadin Impurity B
EINECS	Contact for details

Quality Control

Our Dequalinium Ep Impurity B is manufactured under strict quality systems to ensure the highest standards of purity and traceability. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile, supporting compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines (EP, USP). Certificates of Analysis (COA) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Handle with appropriate personal protective equipment in a well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.