Description

Citalopram Carboxylic Acid Impurity is a high-purity reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the antidepressant Citalopram. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories to ensure drug purity, meet regulatory compliance, and support research into drug degradation pathways.

Application

• As a certified reference standard for the identification and quantification of impurities in Citalopram Hydrobromide active pharmaceutical ingredient (API).
• For method development and validation of chromatographic assays (e.g., HPLC, UPLC) in pharmaceutical quality control laboratories.
• In stability studies to monitor the formation of degradation products in Citalopram formulations.
• As a critical reagent in regulatory filings (e.g., ANDA, NDA) to establish impurity profiles for regulatory bodies like the FDA and EMA.
• For research and development of synthetic pathways and purification processes for Citalopram.
• Use in academic and institutional research focusing on the pharmacology and metabolism of selective serotonin reuptake inhibitors (SSRIs).

Basic Information

Product Name	Citalopram Carboxylic Acid Impurity
CAS No.	440121-09-5
Molecular Formula	C20H21FN2O2
Molecular Weight	340.40 g/mol
Synonyms	1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carboxylic Acid; Citalopram Carboxylic Acid; Citalopram Impurity C; Citalopram Related Compound C; Citalopram Acid Impurity; 5-Carboxycitalopram; Citalopram Degradant
EINECS	Contact for details

Quality Control

Every batch of Citalopram Carboxylic Acid Impurity is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and confirming compliance with in-house specifications suitable for pharmaceutical reference standard use.

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.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference retention time
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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