Description

Desloratadine Impurity 3 (CAS NO 1346600-61-0) is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Desloratadine. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance (QA), and regulatory affairs to identify, quantify, and control this specific impurity during drug development and production. Maintaining a reliable supply of this well-characterized impurity is essential for compliance with stringent global pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the identification and quantification of Desloratadine Impurity 3 in API and finished drug product testing.
• Method Development and Validation: Used in the development, optimization, and validation of analytical methods, particularly HPLC and LC-MS, for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing to monitor and control impurity levels, ensuring product consistency and compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of Desloratadine to understand degradation pathways.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., FDA, EMA) to establish impurity specifications and justify safety thresholds.
• Research and Development: Used in synthetic chemistry research to study the formation and fate of this impurity during the API manufacturing process.

Basic Information

Product Name	Desloratadine Impurity 3
CAS No.	1346600-61-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	8-Chloro-6,11-dihydro-11-(4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine; Desloratadine Related Compound 3; Desloratadine EP Impurity C; Desloratadine USP Impurity; A potential degradation product of Desloratadine
EINECS	Contact for details

Quality Control

Every batch of Desloratadine Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH guidelines and can supply materials suitable for use in regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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