Description

Escitalopram Impurity CAS NO 91283-87-3 is a high-purity reference standard used in the pharmaceutical development and manufacturing process. This compound is critical for analytical method development, validation, and quality control testing of the active pharmaceutical ingredient (API) Escitalopram. It is essential for pharmaceutical companies, contract research organizations (CROs), and analytical laboratories focused on ensuring drug safety, efficacy, and regulatory compliance. The availability of this well-characterized impurity supports the stringent requirements of modern pharmacopeial standards.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Escitalopram API.
• Critical component in analytical method development and validation (HPLC, UPLC, GC) for pharmaceutical quality control.
• Used in stability studies and forced degradation studies to understand the degradation pathways of Escitalopram.
• Essential for regulatory submissions (e.g., ANDA, NDA) to demonstrate comprehensive impurity profiling to agencies like the FDA and EMA.
• Serves as a system suitability test component in chromatographic assays.
• Used in research and development to study the metabolism and pharmacokinetics of related compounds.
• Supports GMP-compliant manufacturing by providing a benchmark for in-process control (IPC) testing.

Basic Information

Product Name	Escitalopram Impurity
CAS No.	91283-87-3
Molecular Formula	C20H21FN2O
Molecular Weight	324.40 g/mol
Synonyms	(1S)-1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-5-isobenzofurancarbonitrile; Escitalopram Related Compound; Escitalopram Desmethyl Impurity; Citalopram Impurity F; Lundbeck Impurity; S-Citalopram Impurity; 5-Cyano-1-(4-fluorophenyl)-3-[(1S)-1-(3-dimethylaminopropyl)]phthalane
EINECS	Contact for details

Quality Control

Every batch of Escitalopram Impurity CAS 91283-87-3 is manufactured and controlled under a strict quality management system. Our products undergo rigorous analytical testing, including HPLC, GC, NMR, and MS, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against established specifications. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines for impurities in new drug 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 must be kept under inert conditions or in a desiccator after opening to prevent degradation. Keep the container tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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