Description

Escitalopram Impurity CAS NO 1363421-46-8 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the antidepressant Escitalopram. This impurity is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification, quantification, and control of related substances during manufacturing. It is an essential material for analytical laboratories, research institutions, and pharmaceutical companies engaged in method development, stability studies, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material for the identification and structural elucidation of related substances in Escitalopram Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurities.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to quantify specified impurities, ensuring every batch of Escitalopram API meets stringent pharmacopeial (USP, EP) and ICH guidelines.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to establish shelf-life and storage recommendations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate control strategy and impurity thresholds as per ICH Q3A(R2) and Q3B(R2).
• Research and Development: Facilitates process chemistry research to understand impurity formation pathways and optimize synthesis routes for cleaner API production.

Basic Information

Product Name	Escitalopram Impurity
CAS No.	1363421-46-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Escitalopram Related Compound; Escitalopram Process Impurity; Escitalopram Degradant; (1S)-1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-5-isobenzofurancarbonitrile Impurity; Citalopram Impurity; S-Citalopram Impurity; LU 26-054 Impurity
EINECS	Contact for details

Quality Control

Our Escitalopram Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

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); ensure the container is kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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