Description

Citalopram Ep Impurity E CAS NO 64169-47-7 is a specified impurity and reference standard used in the analytical profiling of the antidepressant drug Citalopram. This compound is critical for pharmaceutical quality control and regulatory compliance, ensuring the safety and efficacy of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development, stability studies, and method validation.

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 High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in compliance with ICH Q2(R1) guidelines.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to monitor and control the level of this specific impurity, ensuring it remains within the acceptable threshold set by pharmacopeial standards (e.g., EP, USP).
• Stability Studies: Used to track the formation of degradation products in Citalopram formulations under various stress conditions (e.g., heat, humidity, light) as per ICH Q1A(R2) stability testing guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over product-related impurities.
• Research & Development: Serves as a key intermediate or marker in synthetic chemistry research and impurity profiling studies for Citalopram and related compounds.

Basic Information

Product Name	Citalopram Ep Impurity E
CAS No.	64169-47-7
Molecular Formula	C20H21FN2O
Molecular Weight	324.39 g/mol
Synonyms	1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile; Citalopram Impurity E; Citalopram Related Compound E; Citalopram EP Impurity E; Desmethylcitalopram; Lu 10-202; Norcitalopram; 5-Cyano-1-(4-fluorophenyl)-1-[3-(dimethylamino)propyl]phthalane
EINECS	Contact for details

Quality Control

Our Citalopram Ep Impurity E is manufactured and tested under strict quality management systems. Each batch is characterized and qualified using advanced analytical techniques to ensure identity, purity, and traceability, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters as per current pharmacopeial expectations (EP/USP) and ICH guidelines.

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 reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified 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.