Description

Citalopram n-Oxide CAS NO 63284-72-0 is a key pharmaceutical intermediate and a major metabolite of the widely prescribed antidepressant Citalopram. Its significance lies in its critical role in drug metabolism studies, impurity profiling, and the development of analytical reference standards for quality control in active pharmaceutical ingredient (API) manufacturing. This high-purity compound is essential for research and development laboratories, analytical chemists, and manufacturers in the pharmaceutical and life sciences industries who require reliable reference materials for method validation and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantitative and qualitative analysis of Citalopram and related formulations.
• Metabolite Studies: Used in pharmacokinetic and pharmacodynamic research to understand the biotransformation pathways of Citalopram.
• Impurity Profiling: Critical for identifying and quantifying process-related impurities and degradation products in Citalopram API batches to meet ICH guidelines.
• Analytical Method Development: Employed in the development and validation of HPLC, LC-MS, and other chromatographic methods for drug substance analysis.
• Quality Control & Assurance: Acts as a system suitability standard in quality control laboratories to ensure the accuracy and precision of analytical instruments and procedures.
• Regulatory Compliance: Supports documentation for regulatory submissions (e.g., to FDA, EMA) by providing a characterized impurity standard for drug master files.

Basic Information

Product Name	Citalopram n-Oxide
CAS No.	63284-72-0
Molecular Formula	C20H21FN2O2
Molecular Weight	340.39 g/mol
Synonyms	1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile N-Oxide; Citalopram Impurity F (EP); Citalopram N-Oxide (USP); Citalopram Related Compound F; Citalopram Metabolite N-Oxide; Lu 10-202-B; 5-Cyano-1-(4-fluorophenyl)-1,3-dihydro-1-[3-(dimethylamino)propyl]isobenzofuran N-Oxide
EINECS	Contact for details

Quality Control

Our Citalopram n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity determination by HPLC, and control of specified impurities. We provide full traceability and Certificates of Analysis (COA) that detail all test results against established specifications, supporting compliance with pharmacopeial standards (USP, EP) and ICH Q3A/B guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The compound is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤ 0.5%

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