Description

Escitalopram Butyryl 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 purity, safety, and efficacy of the final drug product by enabling the accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory affairs teams involved in the development and manufacturing of antidepressant medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of the butyryl impurity in escitalopram API batches.
• Method Development and Validation: Crucial for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS) protocols.
• Quality Control & Assurance (QC/QA): Used in routine impurity profiling to ensure API batches comply with stringent pharmacopeial standards (e.g., USP, EP, ICH Q3A/B guidelines).
• Stability Studies: Employed to monitor impurity levels in escitalopram formulations under various stress conditions to determine shelf-life and storage requirements.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and marketing authorization applications.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of escitalopram to minimize the formation of this specific impurity.

Basic Information

Product Name	Escitalopram Butyryl Impurity
CAS No.	1803244-58-7
Molecular Formula	C21H22FN2O2
Molecular Weight	353.42 g/mol
Synonyms	Escitalopram Butyryl Related Compound; Escitalopram Butyryl Analog; (S)-1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile Butyryl Derivative; Butyryl Escitalopram; Escitalopram Process Impurity; SCT Butyryl Impurity; Lexapro Butyryl Impurity
EINECS	Contact for details

Quality Control

Every batch of Escitalopram Butyryl Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with industry and regulatory standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters.

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 desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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