Toxicology Report

Science-backed PDE/ADE, OEL & OEB derivation by certified toxicologists with ex-agency experts -

Escitalopram Oxalate

What is Escitalopram Oxalate?

CAS No: 219861-08-2

Escitalopram, the S-enantiomer of citalopram, belongs to a class of antidepressant agents known as selective serotonin-reuptake inhibitors (SSRIs). Despite distinct structural differences between compounds in this class, SSRIs possess similar pharmacological activity. As with other antidepressant agents, several weeks of therapy may be required before a clinical effect is seen. SSRIs are potent inhibitors of neuronal serotonin reuptake. They have little to no effect on norepinephrine or dopamine reuptake and do not antagonize α- or β-adrenergic, dopamine D2 or histamine H1 receptors. During acute use, SSRIs block serotonin reuptake and increase serotonin stimulation of somatodendritic 5-HT1A and terminal autoreceptors. Chronic use leads to desensitization of somatodendritic 5-HT1A and terminal autoreceptors. The overall clinical effect of increased mood and decreased anxiety is thought to be due to adaptive changes in neuronal function that leads to enhanced serotonergic neurotransmission. Side effects include dry mouth, nausea, dizziness, drowsiness, sexual dysfunction and headache. Side effects generally occur within the first two weeks of therapy and are usually less severe and frequent than those observed with tricyclic antidepressants. Escitalopram may be used to treat major depressive disorder (MDD) and generalized anxiety disorder (GAD). Escitalopram is a furancarbonitrile that is one of the Serotonin uptake inhibitors used as an antidepressant. The drug is also effective in reducing ethanol uptake in alcoholics and is used in depressed patients who also suffer from tardive dyskinesia in preference to tricyclic antidepressants, which aggravate this condition; Escitalopram (Cipralex) is a medication developed by the Danish pharmaceutical company Lundbeck, that acts as a selective serotonin reuptake inhibitor (SSRI). It is typically used as an antidepressant to treat depression associated with mood disorders, although it also may be used in the treatment of body dysmorphic disorder and anxiety, including OCD. In the United States, the drug is marketed under the name Lexapro by Forest Laboratories, Inc; Escitalopram is a medication that acts as a selective serotonin reuptake inhibitor (SSRI). It is typically used as an antidepressant to treat depression associated with mood disorders, although it also may be used in the treatment of body dysmorphic disorder and anxiety, including OCD; Discontinuation from antidepressants, especially abruptly, has been known to cause certain withdrawal symptoms. One possible discontinuation symptom from Escitalopram is a type of spontaneous nerve pulse known as paresthesia or ‘electric shock sensations’, described by some patients as a feeling of small electric shocks, which may be accompanied by dizziness. These pulses may be short in duration, only milliseconds long, may affect any region of the body, and recur up to several times a minute, throughout all waking hours. They can be increased by physical activity, but are not solely linked to muscular activity. Other discontinuation symptoms include extreme sensitivity to loud sounds and bright lights, chills, hot flushes, cold sweats, reddening of the face, abdominal pain, weight gain and extreme mental fatigue.

To derive PDE/ADE, OEL, and OEB values, Masuu Global follows a scientifically justified, risk-based toxicological assessment approach in accordance with internationally recognized guidelines and industry best practices that are widely accepted by regulatory authorities, including European Medicines Agency (EMA), Pharmaceutical Inspection Co-operation Scheme (PIC/S), and Agência Nacional de Vigilância Sanitária (ANVISA).

Request Your Assessment

Add this compound to your inquiry list and our team will follow up with full documentation, pricing, and licensing terms.

View Inquiry List →
What's included:
Full OEL derivation · ADE/PDE value · Control band assignment · All cited references · EMA / ICH Q9 compliance
9,000+
Toxicological & Exposure
Assessment Reports Delivered
70+
Subject Matter Experts
across global operations
12
In-House Ex-Agency
Toxicologists
3
Certification Bodies:
ERT · UKRT · DABT

Assessment Methodology

Masuu Global follows a scientifically justified, risk-based toxicological approach aligned with internationally recognized guidelines accepted by EMA, PIC/S, and ANVISA.

EMA – Guideline on Setting Health-Based Exposure Limits (HBELs)

Provides the framework for establishing scientifically justified PDE/ADE values for use in shared manufacturing facilities.

PIC/S – Shared Facilities and Contamination Control Guidance

Supports the application of HBEL-based approaches for cross-contamination prevention and cleaning validation.

ICH Q9 – Quality Risk Management

Provides a structured methodology for risk identification, assessment, control, communication, and review.

ICH M7 – Assessment and Control of DNA-Reactive (Mutagenic) Impurities (where applicable)

Applied for compounds with potential mutagenic or genotoxic concerns.

Risk-Based Toxicological Assessment

Comprehensive evaluation of available toxicological and pharmacological data, including NOAEL, LOAEL, BMDL, pharmacological potency, carcinogenicity, reproductive and developmental toxicity, sensitization potential, and target organ toxicity.

Weight-of-Evidence (WoE) Approach

Integration and critical review of all relevant data sources, including non-clinical studies, clinical studies, human exposure data, pharmacological information, post-marketing safety data, and structure–activity relationship (SAR/QSAR) assessments.

Report Preparation Process

Every assessment moves through a rigorous five-stage workflow — from data gathering to regulatory-ready delivery.

01

Comprehensive Data Review

Assessment of pharmacology, toxicology, clinical data, literature, and available regulatory information.

02

Scientific Evaluation

Identification of critical endpoints and selection of appropriate exposure limits.

03

PDE / HBEL Derivation

Transparent and scientifically justified calculations aligned with global toxicological principles.

04

Ex-Agency Expert Review (Our Differentiator)

Reports are reviewed with an ex-agency perspective, bringing regulatory expectations, inspection readiness, and practical implementation into every assessment.

05

Final Report Delivery

Regulatory-ready reports with scientific rationale, calculations, and clear recommendations by certified toxicologists (ERT, UKRT and DABT).

Why Masuu Global?

Our ex-agency toxicologists bring a practical regulatory perspective that transforms how assessments are built, reviewed, and defended.

Regulatory expectation–driven assessments aligned with how authorities actually evaluate submissions.

Inspection-ready reports — scientifically defensible and audit-prepared from day one.

Faster review cycles with direct decision support from certified toxicologists (ERT, UKRT, DABT).

Practical implementation recommendations that translate science into actionable contamination control.

Reduced internal effort — offload complex assessments without sacrificing quality or defensibility.

Global reach across PDE/ADE, HBEL, OEL, OEB, cleaning validation, and impurity assessments.

Ready to request your assessment?

Add this compound to your inquiry list, or browse our full database of 3,000+ molecules.

Book a Demo