Description

Oxime Impurity Of Escitalopram Oxalate is a high-purity reference standard and a key process-related impurity in the synthesis of the antidepressant escitalopram oxalate. This compound is critical for pharmaceutical research and development, enabling accurate analytical method development, stability studies, and rigorous quality control of the active pharmaceutical ingredient (API). It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the oxime impurity in escitalopram oxalate API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor and control impurity profiles.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to understand the degradation pathways of escitalopram oxalate.
• Quality Control & Batch Release Testing: A critical component in the quality control laboratory for routine analysis of API batches to ensure they meet ICH Q3A/B guidelines for impurities.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA) with agencies like the US FDA and EMA.
• Process Chemistry Research: Used by process chemists to study and optimize synthetic routes to minimize the formation of this specific impurity.

Basic Information

Product Name	Oxime Impurity Of Escitalopram Oxalate
CAS No.	227954-88-3
Molecular Formula	C21H22FN3O3
Molecular Weight	383.42 g/mol
Synonyms	(1S)-1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-5-isobenzofurancarbonitrile oxime; Escitalopram Oxime Impurity; Escitalopram Related Compound; (S)-Citalopram Oxime Impurity; 1,3-Dihydro-1-[(3-dimethylamino)propyl]-1-(4-fluorophenyl)-5-isobenzofurancarbonitrile oxime; (S)-1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile oxime; Escitalopram Oxalate Oxime Impurity
EINECS	Contact for details

Quality Control

Our Oxime Impurity Of Escitalopram Oxalate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and MS, and residual solvent analysis, to ensure compliance with ICH Q3A, Q3B, and relevant pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment to guarantee traceability and reliability for your critical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 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.