Description

Desloratadine 4,8-Dichloro Impurity is a key chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Desloratadine. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance by accurately identifying and quantifying this specific process-related impurity. It is an essential tool for research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Impurity Reference Standard: Primary use as a certified reference material for the identification and quantification of the 4,8-dichloro impurity in Desloratadine API and finished drug products.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical component in developing, validating, and verifying chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Employed to track the formation of this degradation product under various stress conditions (e.g., heat, light, humidity) to establish shelf-life and storage recommendations.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control strategy.
• Research on Synthetic Pathways: Aids in chemical process research to understand and optimize the synthesis of Desloratadine, helping to minimize the formation of this impurity.

Basic Information

Product Name	Desloratadine 4,8-Dichloro Impurity
CAS No.	133330-63-9
Molecular Formula	C19H17Cl2N3
Molecular Weight	358.27 g/mol
Synonyms	4,8-Dichlorodesloratadine; 8-Chloro-11-(4-piperidinylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine; Desloratadine Impurity C; Desloratadine Related Compound C; 4,8-Dichloro-6,11-dihydro-11-(4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine; Desloratadine Dichloro Impurity; 4,8-Dichloro Analog of Desloratadine
EINECS	Contact for details

Quality Control

Every batch of Desloratadine 4,8-Dichloro Impurity is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with specified purity criteria, typically ≥95% (HPLC).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed and desiccated to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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