Description

Citalopram Ep Impurity F CAS NO 1644389-68-3 is a high-purity reference 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 safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is an essential material for research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Primary use as a pharmaceutical reference standard for Citalopram Hydrobromide.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS).
• Used for impurity identification and quantification in drug substance and finished product batches.
• Essential for conducting stability studies and establishing impurity profiles.
• Supports regulatory submissions (e.g., for FDA, EMA) by providing characterized impurity data.
• Valuable for research and development of Citalopram synthesis and purification processes.
• Used in quality control laboratories for routine batch release testing.
• Serves as a system suitability component in chromatographic assays.

Basic Information

Product Name	Citalopram Ep Impurity F
CAS No.	1644389-68-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Citalopram Impurity F; Citalopram Related Compound F; Citalopram EP Impurity F; 1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile; Citalopram Nitrile Impurity; Citalopram Process Impurity; Desmethylcitalopram Nitrile; Potential synthesis intermediate for Citalopram.
EINECS	Contact for details

Quality Control

Our Citalopram Ep Impurity F is manufactured under controlled conditions and subjected to rigorous analytical testing to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. Each batch is characterized using advanced techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing all test results against established specifications. Our quality system is designed to support compliance with cGMP, ICH Q3A/B guidelines, and relevant pharmacopoeial standards.

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 must be kept under inert conditions or in a desiccator to maintain stability and purity. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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