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Paroxetine Hydrochloride Anhydrous API is a selective serotonin reuptake inhibitor (SSRI) used globally in the treatment of depression, anxiety disorders, panic attacks, and obsessive-compulsive disorder (OCD). It functions by enhancing serotonin levels in the brain, thereby improving mood, sleep, and emotional stability.
At Bluepill Express, we are a WHO-GMP, ISO 9001:2015, and cGMP-certified manufacturer and exporter of Paroxetine Hydrochloride Anhydrous Active Pharmaceutical Ingredient (API). Our API is manufactured under strict international standards, complying with USP, BP, IP, and EP pharmacopeial specifications.
We ensure high assay purity (≥99%), consistent crystalline quality, and excellent flow properties, making it ideal for tablet and capsule formulations. The anhydrous form provides improved stability, compressibility, and shelf life compared to the hydrated counterpart.
Therapeutic Applications:
- Major Depressive Disorder (MDD)
- Generalized Anxiety Disorder (GAD)
- Obsessive-Compulsive Disorder (OCD)
- Panic Disorder and Social Anxiety
- Post-Traumatic Stress Disorder (PTSD)
- Premenstrual Dysphoric Disorder (PMDD)
Mechanism of Action:
Paroxetine selectively inhibits the reuptake of serotonin (5-HT) in the presynaptic neurons of the central nervous system, leading to increased serotonin availability in the synaptic cleft. This enhances neurotransmission and helps alleviate symptoms of depression and anxiety. It has minimal effects on norepinephrine and dopamine reuptake, ensuring targeted action with fewer side effects.
Technical Specifications:
- Chemical Name: (3S,4R)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine hydrochloride (anhydrous)
- Molecular Formula: C₁₉H₂₀FNO₃·HCl
- Molecular Weight: 365.83 g/mol
- CAS Number: 110429-35-1
- Description: White to off-white crystalline powder
- Assay (on dried basis): NLT 98.0% and NMT 102.0%
- Melting Point: 120°C – 123°C
- Solubility: Freely soluble in methanol and ethanol; slightly soluble in water
- Storage Conditions: Store below 30°C in airtight containers; protect from moisture and light
Pharmacological Classification:
- Therapeutic Class: Antidepressant (Selective Serotonin Reuptake Inhibitor – SSRI)
- Pharmacopoeial Standards: IP / BP / USP / EP
- Dosage Form Applications:
- Oral tablets (10 mg, 20 mg, 30 mg, 40 mg)
- Capsules
- Extended-release (ER) formulations
Quality & Manufacturing – Bluepill Express Standards:
- Produced in WHO-GMP and cGMP-certified facilities
- High purity crystalline anhydrous form for maximum stability
- Analytical validation through HPLC, IR, and UV spectroscopy
- Batch-to-batch uniformity and controlled particle size distribution
- COA, MSDS, and DMF documentation available for export registration
- Manufactured as per global regulatory compliance standards (EU, USFDA, WHO)
Advantages of Bluepill Express Paroxetine Hydrochloride Anhydrous API:
- Anhydrous form ensures superior stability and lower moisture absorption
- High assay purity and low residual solvents
- Excellent flow and compressibility for direct tablet compression
- Suitable for immediate and controlled-release dosage forms
- Globally export-ready with all regulatory documentation
Packaging & Export Details:
- Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE drums with double LDPE liners
- Shelf Life: 3 years under recommended storage
- Labeling: As per pharmacopeial and international export standards
- Export Markets: Europe, Africa, Asia-Pacific, Latin America, Middle East
- Documentation Provided:
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Drug Master File (DMF – on request)
- Stability Data and Validation Reports
