Description

Escitalopram Acid Impurity is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Escitalopram Oxalate. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification and quantification of related substances. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on research, development, and compliance testing.

Application

• Primary use as a certified reference standard for impurity identification and quantification in Escitalopram API.
• Method development and validation for HPLC, UPLC, and other chromatographic techniques in pharmaceutical analysis.
• Quality control and batch release testing to ensure API meets pharmacopeial standards (e.g., USP, EP, ICH guidelines).
• Stability studies to monitor impurity profiles in drug substances and finished products over time.
• Research and development of generic formulations of Escitalopram.
• Calibration of analytical equipment for precise and accurate measurements.
• Training and educational purposes in analytical chemistry and pharmaceutical sciences.

Basic Information

Product Name	Escitalopram Acid Impurity
CAS No.	1133881-04-5
Molecular Formula	C20H21FN2O
Molecular Weight	324.39 g/mol
Synonyms	Escitalopram Acid Impurity; Escitalopram Related Compound; (S)-1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carboxylic Acid; Escitalopram Carboxylic Acid; S-Citalopram Acid; Lexapro Acid Impurity; Cipralex Acid Impurity; Escitalopram Impurity A (Acid Form)
EINECS	Contact for details

Quality Control

Every batch of our Escitalopram Acid Impurity is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by validated chromatographic methods (HPLC). A detailed Certificate of Analysis (COA) is supplied with each shipment, documenting batch-specific results for purity, related substances, and residual solvents, ensuring compliance with ICH Q3A and Q3B 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 matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.