Description

Desloratadine Impurity 6 is a specified, high-purity chemical reference standard used in the analytical profiling of the active pharmaceutical ingredient (API) Desloratadine. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products by serving as a benchmark for impurity identification and quantification during manufacturing and quality control processes. It is an essential material for analytical laboratories, pharmaceutical R&D departments, and quality assurance teams focused on method development, validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the analysis of Desloratadine API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to establish and validate chromatographic methods for accurately detecting and quantifying this specific impurity.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels against ICH guidelines, ensuring product safety.
• Stability Studies: A key component in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Research & Development: Supports synthetic route optimization and process chemistry research by helping to identify and control the formation of this impurity.

Basic Information

Product Name	Desloratadine Impurity 6
CAS No.	38092-90-9
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; Desloratadine EP Impurity B; Desloratadine USP Related Compound B; 8-Chloro-11-(piperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine; Desloratadine Impurity B (EP); Loratadine Descarbethoxy Impurity
EINECS	Contact for details

Quality Control

Every batch of Desloratadine Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards (USP/EP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality documentation.

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 should be handled in a dry environment to prevent degradation.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.