Description

Citalopram Impurity 14 is a designated impurity standard used in the analytical profiling and quality control of the antidepressant drug Citalopram. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and as a reference standard in chromatographic analysis.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Citalopram Hydrobromide active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during drug synthesis and stability studies.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure the accuracy and precision of impurity assays, supporting compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Submissions: Provides necessary data for impurity identification and characterization reports required for drug master files (DMF), ANDAs, and other regulatory filings with agencies like the FDA and EMA.
• Stability Studies: Employed to track the formation and levels of this specific impurity under various stress conditions (e.g., heat, humidity, light) as part of forced degradation and shelf-life studies.
• Process Chemistry Research: Used by chemists to understand and control the formation of this impurity during the synthesis, purification, and scale-up of Citalopram manufacturing processes.

Basic Information

Product Name	Citalopram Impurity 14
CAS No.	1470362-85-6
Molecular Formula	C20H21FN2O
Molecular Weight	324.40 g/mol
Synonyms	1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile; Citalopram Desmethyl Impurity; Citalopram Related Compound 14; Desmethylcitalopram; Lu 10-371; Norcitalopram
EINECS	Contact for details

Quality Control

Every batch of Citalopram Impurity 14 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.