IndiaMart
FIEO
Trazodone Hydrochloride is a serotonin antagonist and reuptake inhibitor (SARI) widely used for the treatment of major depressive disorder, anxiety, and insomnia. It works by inhibiting serotonin reuptake and modulating serotonin receptors (5-HT2A/2C), producing antidepressant, anxiolytic, and sedative effects.
Bluepill Express manufactures high-purity Trazodone HCl API under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities, ensuring consistent quality, stability, and compliance with global pharmacopoeial standards (IP, BP, USP, EP). The API is suitable for tablet and capsule formulations, offering reliable therapeutic performance.
Therapeutic Uses
- Major Depressive Disorder: Effective relief of depressive symptoms
- Anxiety Disorders: Reduces symptoms of generalized anxiety
- Insomnia / Sleep Disturbance: Short-term sedative effect
- Combination Therapy: Adjunct to other antidepressants in resistant depression
- Off-label Uses: Chronic pain management, PTSD, and behavioral disorders (under medical supervision)
Mechanism of Action
Trazodone HCl acts as a serotonin reuptake inhibitor and antagonist at 5-HT2A/2C receptors, which:
- Increases serotonin availability in the CNS
- Modulates receptor activity to reduce anxiety and improve mood
- Produces sedative effects via histamine H1 receptor antagonism
- Minimal anticholinergic effects, providing a favorable side-effect profile
Pharmacological Information
- Chemical Name: 2-{3-[4-(3-Chlorophenyl)piperazin-1-yl]propyl}-1,2,4-triazolo[4,3-a]pyridin-3(2H)-one hydrochloride
- Molecular Formula: C19H22ClN3O·HCl
- Molecular Weight: 372.82 g/mol
- CAS Number: 17317-16-3
- Therapeutic Class: Antidepressant / Serotonin Modulator
- Pharmacological Class: SARI (Serotonin Antagonist and Reuptake Inhibitor)
- ATC Code: N06AX05
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to off-white crystalline powder |
| Solubility | Freely soluble in water and ethanol; slightly soluble in chloroform |
| Melting Point | 246°C – 250°C |
| pH (1% aqueous solution) | 5.0 – 7.0 |
| Storage | Store below 25°C in a dry, ventilated area, protected from light and moisture |
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR, UV, and HPLC positive |
| Assay (Purity) | ≥ 99.0% (HPLC) |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 10 ppm |
| Related Substances | ≤ 0.5% (individual impurity) |
| Bulk Density | 0.40 – 0.55 g/mL |
| Tapped Density | 0.55 – 0.70 g/mL |
Applications
Trazodone HCl API is used in:
- Tablet and capsule formulations for depression and anxiety
- Combination therapy with other CNS drugs
- Sleep aid formulations
- Bulk pharmaceutical production for domestic and international markets
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Method of Analysis (MOA)
- Stability Data (ICH-compliant)
- Regulatory Dossier / DMF (on request)
Packaging & Export Details
- Available Packs: 1 kg | 5 kg | 10 kg | 25 kg HDPE drums with double poly liners
- Labeling: Product name, batch number, manufacturing/expiry dates, storage instructions
- Shelf Life: 36 months under recommended storage conditions
- Export Markets: Africa, Asia, Latin America, Europe, Middle East
