SERTRALINE HYDROCHLORIDE

Sertraline Hydrochloride is a potent selective serotonin reuptake inhibitor (SSRI) widely prescribed for the treatment of depression, anxiety disorders, panic attacks, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), and social anxiety disorder (SAD). It works by increasing serotonin levels in the brain — a neurotransmitter responsible for mood regulation — thereby restoring emotional balance and reducing symptoms of depression and anxiety.

At Bluepill Express, we manufacture and export pharma-grade Sertraline Hydrochloride API under WHO-GMP, ISO, and cGMP-certified facilities. Our API meets stringent IP, BP, USP, and EP pharmacopeial specifications, ensuring exceptional purity, consistency, and compliance suitable for both regulated and semi-regulated markets.

Sertraline Hydrochloride is one of the most trusted SSRIs globally due to its favorable efficacy, safety profile, and low sedation potential. Our advanced production ensures uniform particle size, high assay value, and optimal solubility for precise formulation in solid oral dosage forms.

Therapeutic Applications:

• Major Depressive Disorder (MDD)
• Obsessive-Compulsive Disorder (OCD)
• Panic Disorder and Anxiety Disorders
• Post-Traumatic Stress Disorder (PTSD)
• Premenstrual Dysphoric Disorder (PMDD)

Mechanism of Action:

Sertraline selectively inhibits the presynaptic reuptake of serotonin (5-HT), increasing serotonin concentration in the synaptic cleft. This enhancement in serotonergic activity helps regulate mood, reduce anxiety, and alleviate depressive symptoms without significantly affecting other neurotransmitters such as norepinephrine or dopamine.

Technical Specifications:

• Chemical Name: (1S,4S)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride
• Molecular Formula: C₁₇H₁₇Cl₂N·HCl
• Molecular Weight: 342.70 g/mol
• CAS Number: 79559-97-0
• Appearance: White to off-white crystalline powder
• Assay (on dried basis): NLT 98.0% and NMT 102.0%
• Solubility: Slightly soluble in water; freely soluble in methanol and ethanol
• Melting Point: 246°C – 250°C
• Storage Conditions: Store below 25°C, protected from moisture and direct sunlight

Pharmacological Classification:

• Therapeutic Class: Antidepressant (SSRI)
• Pharmacopoeial Standards: IP / BP / USP / EP
• Common Formulations: Tablets (25 mg, 50 mg, 100 mg), Capsules, Oral Solutions

Manufacturing Excellence – Bluepill Express:

• WHO-GMP and cGMP-certified production units
• High assay purity (≥99%) and low impurity profile
• Controlled particle size for excellent flowability and blending
• Stability-tested API under ICH guidelines
• Comprehensive documentation support (COA, MSDS, DMF, Stability Data)

Advantages of Bluepill Express Sertraline Hydrochloride API:

• Compliant with IP/BP/USP/EP pharmacopeias
• Produced under ISO 9001:2015 quality management
• Low moisture and solvent residue levels
• Excellent bioavailability and formulation compatibility
• Trusted by global pharmaceutical formulators

Packaging & Export Details:

• Packaging Sizes: 5 kg, 10 kg, 25 kg HDPE drums with double liners
• Labeling: Export and regulatory-compliant
• Shelf Life: 36 months from manufacturing date
• Export Markets: Asia, Africa, Middle East, Europe, Latin America
• Documentation Provided:
  • Certificate of Analysis (COA)
  • Material Safety Data Sheet (MSDS)
  • Stability Data
  • Technical Data Sheet (TDS)
  • Drug Master File (DMF) available upon request