Description

Desloratadine Impurity B CAS NO 117796-50-6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Desloratadine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and routine quality control testing. The availability of a well-characterized impurity standard is essential for maintaining stringent pharmacopeial standards and product integrity.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Desloratadine API and finished drug products.
• Essential for analytical method development and validation (HPLC, UPLC, GC) in pharmaceutical quality control laboratories.
• Used in stability studies to monitor the formation of degradation products in Desloratadine formulations.
• Serves as a critical material for regulatory submissions (e.g., to FDA, EMA) to establish impurity profiles and specifications.
• Applied in pharmaceutical research to study the metabolism and degradation pathways of Desloratadine.
• Utilized by contract research organizations (CROs) and testing labs offering compliance and batch release services.

Basic Information

Product Name	Desloratadine Impurity B
CAS No.	117796-50-6
Molecular Formula	C19H19ClN2
Molecular Weight	310.82 g/mol
Synonyms	8-Chloro-6,11-dihydro-11-(4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine; Desloratadine Related Compound B; DL-1; Desloratadine EP Impurity B; Desloratadine USP Related Compound B; 11-(4-Piperidinylidene)-8-chloro-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine
EINECS	Contact for details

Quality Control

Every batch of Desloratadine Impurity B is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including relevant pharmacopeial monographs (USP, EP). Comprehensive characterization is performed using advanced analytical techniques. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are provided with each shipment and are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. Keep the container tightly sealed in a cool, dry, and well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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