Description

Escitalopram Ep Impurity I is a designated impurity reference standard used in the pharmaceutical development and quality control of Escitalopram, a widely prescribed antidepressant. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with stringent pharmacopeial standards such as EP (European Pharmacopoeia) and USP (United States Pharmacopeia).

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Escitalopram Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) in pharmaceutical R&D and quality control laboratories.
• Critical component in stability studies and forced degradation studies to monitor impurity profiles over time.
• Used for regulatory compliance and submission, providing necessary data to meet EP, USP, ICH, and FDA guidelines.
• Serves as a system suitability standard in routine quality control testing of Escitalopram batches.
• Supports pharmacopeial testing to ensure drug substances and products conform to specified purity limits.

Basic Information

Product Name	Escitalopram Ep Impurity I
CAS No.	1370643-22-3
Molecular Formula	C20H21FN2O
Molecular Weight	324.39 g/mol
Synonyms	Escitalopram Impurity I (EP); (1S)-1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-5-isobenzofurancarbonitrile; Escitalopram Related Compound I; S-Citalopram Impurity I; 1,3-Dihydro-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-5-isobenzofurancarbonitrile; (S)-1-(3-(Dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile; Escitalopram EP Impurity A (in some references); Lexapro Impurity I.
EINECS	Contact for details

Quality Control

Every batch of Escitalopram Ep Impurity I is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including relevant pharmacopeial monographs (EP, USP). Comprehensive characterization is performed using advanced techniques like HPLC, GC, MS, and NMR. A Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere to maintain stability.

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 impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w
Assay	97.0% - 103.0% (on anhydrous basis)

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