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Fluoxetine Hydrochloride is a high-purity selective serotonin reuptake inhibitor (SSRI) API widely used in the treatment of depression, obsessive-compulsive disorder (OCD), bulimia nervosa, and panic disorder. It works by inhibiting the reuptake of serotonin in the central nervous system, enhancing serotonergic activity and improving mood and emotional stability.
Bluepill Express manufactures Fluoxetine Hydrochloride under WHO-GMP, ISO, and cGMP-certified facilities, ensuring exceptional purity, stability, and batch-to-batch consistency. This API is suitable for tablet, capsule, and oral solution formulations and complies with IP, BP, USP, and EP pharmacopoeial standards.
Therapeutic Classification
- Antidepressant
- Selective Serotonin Reuptake Inhibitor (SSRI)
- Anxiety and OCD treatment
- Bulimia and panic disorder management
Mechanism of Action
Fluoxetine Hydrochloride selectively inhibits the reuptake of serotonin (5-HT) at presynaptic nerve terminals, increasing serotonin levels in the synaptic cleft. This enhances serotonergic neurotransmission, improving mood, reducing anxiety, and alleviating depressive symptoms.
Chemical & Composition Information
| Parameter | Details |
|---|---|
| Chemical Name | (±)-N-Methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine hydrochloride |
| Molecular Formula | C17H18F3NO·HCl |
| Molecular Weight | 345.79 g/mol |
| CAS Number | 59333-67-4 |
| Form | Crystalline powder |
| Pharmacopoeial Standards | IP / BP / USP / EP |
| Therapeutic Class | SSRI antidepressant |
Physical & Chemical Properties
Technical Specifications (Bluepill Express Standards)
| Parameter | Specification |
|---|---|
| Assay | 98.0% – 102.0% |
| Identification | IR, UV, and HPLC spectra match reference standard |
| Water Content (KF) | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Related Substances | ≤ 0.5% individual impurity, ≤ 1.0% total impurities |
| Bulk Density | 0.35 – 0.55 g/ml |
| Particle Size Distribution | D90 < 250 μm (customizable) |
| Heavy Metals | ≤ 10 ppm |
| Microbial Limits | Complies with pharmacopeial standards |
Pharmacological Applications
- Major depressive disorder (MDD)
- Obsessive-compulsive disorder (OCD)
- Bulimia nervosa
- Panic disorder
- Off-label use in anxiety and mood disorders
Dosage Forms
- Tablets: 10 mg, 20 mg, 40 mg
- Capsules: 10 mg, 20 mg, 40 mg
- Oral solutions and suspensions
Manufacturing Excellence – Bluepill Express
- WHO-GMP, ISO 9001:2015, and cGMP certified facilities
- Controlled crystallization to maintain high purity
- Batch-to-batch uniformity in particle size, moisture, and assay
- Complete regulatory documentation: COA, MSDS, TDS, DMF-ready dossiers
- Export-ready API with competitive pricing
Packaging & Storage
- Packaged in HDPE drums / fiber containers with PE liners
- Pack sizes: 5 kg / 10 kg / 25 kg
- Shelf Life: 36 months
- Storage: Store below 25°C, in a dry, cool environment, protected from light and moisture
Safety & Handling
- Handle with gloves, mask, and protective goggles
- Avoid inhalation, ingestion, or direct contact with skin/eyes
- Follow GMP and EHS guidelines for handling and disposal
