Description

n-Nitroso Desloratadine is a specific chemical derivative of the antihistamine desloratadine, identified by the CAS registry number 1246819-22-6. This compound is of significant interest in pharmaceutical research and development, primarily serving as a critical reference standard or impurity marker for analytical method development and quality control. It is essential for organizations involved in the synthesis, purification, and regulatory compliance of active pharmaceutical ingredients (APIs). Industries requiring this material include pharmaceutical manufacturers, contract research organizations (CROs), and analytical testing laboratories focused on ensuring drug safety and efficacy.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of nitrosamine impurities in desloratadine API and finished drug products.
• Analytical Method Development: Serves as a critical standard for developing and validating sensitive HPLC, LC-MS, or GC-MS methods to monitor genotoxic impurities (GTIs).
• Regulatory Compliance & Submission: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity levels to meet ICH Q3A/B guidelines.
• Quality Control & Assurance: Employed in routine QC laboratories to establish system suitability and ensure the accuracy of impurity testing protocols.
• Research on Nitrosamine Formation: Acts as a model compound in studies investigating the pathways and mitigation strategies for nitrosamine formation during drug synthesis and storage.
• Stability Studies: Used to assess the potential for nitrosamine generation in drug formulations over time under various storage conditions.

Basic Information

Product Name	n-Nitroso Desloratadine
CAS No.	1246819-22-6
Molecular Formula	C19H19ClN4O
Molecular Weight	354.84 g/mol
Synonyms	Desloratadine Nitroso Impurity; Desloratadine N-Nitroso Derivative; 8-Chloro-6,11-dihydro-11-(4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine N-Nitroso; N-Nitroso Desloratadine; Desloratadine Nitrosamine; NDLA; Desloratadine Related Compound N-Nitroso
EINECS	Contact for details

Quality Control

Our n-Nitroso Desloratadine is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and structural confirmation, to ensure it meets the exacting standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profiles. We support compliance with ICH guidelines and other relevant pharmacopeial standards.

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. The material is light-sensitive and should be handled under appropriate conditions to maintain stability. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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