Description

Desloratadine Impurity CAS NO 50603-12-8 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Desloratadine by accurately identifying and quantifying related substances. It is an essential tool for research scientists, analytical chemists, and quality assurance professionals working in pharmaceutical R&D and production. The impurity standard supports compliance with stringent regulatory guidelines for drug substance characterization.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Desloratadine API and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and GC analytical methods in quality control laboratories.
• Stability Studies & Forced Degradation: Used to monitor the formation of degradation products in Desloratadine under various stress conditions (heat, light, humidity).
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA, ICH) by providing necessary impurity profile data.
• Quality Control & Batch Release Testing: Enables routine testing of Desloratadine batches to ensure they meet pharmacopeial specifications (USP, EP, JP) for related substances.
• Process Chemistry Research: Aids in understanding and controlling the formation of this impurity during the synthesis and purification of Desloratadine.

Basic Information

Item	Details
Product Name	Desloratadine Impurity
CAS No.	50603-12-8
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; Loratadine Impurity; Descarboethoxyloratadine; SCH 34117 Impurity; 50603-12-8; 8-Chloro-11-(piperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine
EINECS	Contact for details

Quality Control

Every batch of Desloratadine Impurity (CAS 50603-12-8) is manufactured and tested under strict quality management systems. The material undergoes comprehensive analytical characterization using techniques including HPLC, GC-MS, NMR, and IR to confirm identity and purity, ensuring it meets the requirements for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, impurities, and chromatographic profiles. Our quality commitment aligns with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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