Description

Loratadine n-Oxide is a key pharmaceutical intermediate and metabolite of the widely used antihistamine, Loratadine. This compound is of significant importance for research and development in the pharmaceutical industry, particularly in the study of drug metabolism, pharmacokinetics, and the synthesis of related active pharmaceutical ingredients (APIs). It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in the development and quality control of antihistamine medications and their metabolites.

Application

• Pharmaceutical Intermediate: A critical building block in the synthesis and research of advanced Loratadine derivatives and related therapeutic compounds.
• Metabolite Reference Standard: Serves as an analytical standard in bioanalytical studies for the identification and quantification of Loratadine metabolites in biological matrices.
• Pharmacokinetic Research: Used in drug metabolism and pharmacokinetic (DMPK) studies to understand the metabolic pathways and clearance of Loratadine.
• Impurity Profiling: Employed as a known impurity or degradation product standard in the quality control and stability testing of Loratadine API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating chromatographic methods (HPLC, LC-MS) for pharmaceutical analysis.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing characterized material for impurity identification and qualification.

Basic Information

Product Name	Loratadine n-Oxide
CAS No.	165739-62-8
Molecular Formula	C22H23ClN2O3
Molecular Weight	398.88 g/mol
Synonyms	Loratadine N-Oxide; Loratadine N-Oxide (Major Metabolite); 8-Chloro-6,11-dihydro-11-(1-oxido-4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine; Desloratadine Impurity G (N-Oxide); Claritin N-Oxide; Loratadine Metabolite; 4-(8-Chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1-piperidine N-oxide
EINECS	Contact for details

Quality Control

Our Loratadine n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and NMR spectroscopy, and residual solvent analysis to ensure it meets stringent specifications for pharmaceutical research. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The material is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Loss on Drying	≤ 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.