Escitalopram Oxalate

Escitalopram Oxalate is the oxalate salt form of escitalopram, a selective serotonin reuptake inhibitor utilized primarily in the treatment of major depressive disorder and generalized anxiety disorder. Produced via advanced asymmetric synthesis and stereoselective crystallization techniques, this active pharmaceutical ingredient exhibits high enantiomeric purity. It functions by inhibiting the neuronal reuptake of serotonin, thereby enhancing serotonergic neurotransmission in the central nervous system.

 

 

Parameter	Specification Details
International Nonproprietary Name	Escitalopram Oxalate
Chemical Name	(1S)-1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-2-benzofuran-5-carbonitrile oxalate
Therapeutic Category	Antidepressant / Selective Serotonin Reuptake Inhibitor
Grade	Pharmaceutical Commercial Grade
Physical Description	White or almost white crystalline powder
Solubility Profile	Sparingly soluble in water; freely soluble in methanol; slightly soluble in ethanol

 

 

Test Parameter	Acceptance Criteria	Analytical Method
Assay (Dried Basis)	98.0% - 102.0%	High-Performance Liquid Chromatography
Appearance of Solution	Clear and colorless	European Pharmacopoeia / United States Pharmacopeia
Chiral Purity (R-enantiomer)	≤ 0.1 %	Chiral Liquid Chromatography
Individual Specified Impurity	≤ 0.10 %	Liquid Chromatography
Total Impurities	≤ 0.5 %	Liquid Chromatography
Loss on Drying	≤ 0.5 %	Gravimetric Analysis
Residue on Ignition	≤ 0.1 %	Sulfated Ash Test
Heavy Metals	≤ 10 ppm	Inductively Coupled Plasma Mass Spectrometry

 

 

Synthesis Route: Asymmetric reduction followed by fractional crystallization to isolate the active S-enantiomer configuration.

 

Cleanroom Classification: Synthesis, isolation, and micronization executed within ISO Class 8 cleanroom environments.

 

Containment & Handling: Closed-system reactors equipped with automated nitrogen purging to prevent moisture absorption and cross-contamination.

 

Batch Scale & Capacity: Commercial-scale production capabilities ranging from multi-hundred-kilogram to metric-ton annual output.

 

Supply Stability: Maintained safety stock of key starting materials and validated dual-sourcing channels for critical raw components.

 

 

Regulatory Dossiers: Drug Master File available for reference and active European Pharmacopoeia compliance data.

 

Certificates of Analysis: Issued for every individual production batch, detailing full analytical results against pharmacopoeial monographs.

 

Compliance Certificates: Good Manufacturing Practice certificates and Written Confirmation for active substances imported into regulated markets.

 

Supporting Data: Full impurity profiling reports, residual solvent validation data, stability study summaries, and TSE/BSE-free statements.

 

 

Primary Packaging	Double-layer food-grade low-density polyethylene bags, heat-sealed to ensure absolute moisture and light protection.
Secondary Packaging	Rigid fiber drums or rigid high-density polyethylene drums lined with tamper-evident seals.
Standard Batch Packaging Size	25 kg net weight per drum.
Storage Conditions	Store below 25°C in a dry, well-ventilated area protected from direct sunlight and moisture.

 

 

Major Depressive Disorder: Formulated into oral tablets and liquid solutions to manage acute and maintenance phases of clinical depression. Restores neurochemical balance by sustaining extracellular serotonin levels in synaptic clefts.

 

Generalized Anxiety Disorder: Utilized in solid oral dosage manufacturing for chronic anxiety management. Regulates emotional and somatic symptoms through continuous central nervous system modulation.

 

Social Anxiety Disorder: Applied in specialized tablet formulations targeting chronic social fear and avoidance behaviors. Supports long-term psychiatric rehabilitation protocols.

 

Panic Disorder: Integrated into precise dose-strength tablets designed to reduce the frequency and intensity of unexpected panic attacks. Stabilizes autonomic nervous system responses over therapeutic treatment cycles.

 

 

 

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