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Risperidone is a second-generation (atypical) antipsychotic widely used in the management of schizophrenia, bipolar disorder, and irritability associated with autism spectrum disorder (ASD). It exhibits a dual mechanism by antagonizing serotonin 5-HT2A receptors and dopamine D2 receptors, balancing neurotransmitter activity in the brain.
Bluepill Express offers high-purity Risperidone API, manufactured under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities, ensuring consistent quality, stability, and pharmacopoeial compliance. Our Risperidone API is suitable for formulation into tablets, orally disintegrating tablets, and oral suspensions for global pharmaceutical markets.
Therapeutic Uses
- Schizophrenia: Management of acute and chronic symptoms
- Bipolar Disorder: Treatment of manic or mixed episodes
- Autism Spectrum Disorder: Management of irritability and aggression in children and adolescents
- Other Psychiatric Disorders: Off-label use under medical supervision
Mechanism of Action
Risperidone works by blocking dopamine D2 receptors in the brain, reducing positive symptoms of psychosis such as hallucinations and delusions. It also antagonizes serotonin 5-HT2A receptors, improving negative symptoms and reducing the risk of extrapyramidal side effects. This dual action makes it effective in mood stabilization and behavioral management.
Pharmacological Information
- Chemical Name: 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one
- Molecular Formula: C23H27FN4O2
- Molecular Weight: 410.49 g/mol
- CAS Number: 106266-06-2
- Therapeutic Class: Atypical Antipsychotic
- Pharmacological Class: Serotonin-Dopamine Antagonist
- ATC Code: N05AX08
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to off-white crystalline powder |
| Solubility | Slightly soluble in water, soluble in methanol and ethanol |
| Melting Point | 170°C – 174°C |
| pH (1% aqueous solution) | 5.5 – 6.5 |
| Storage | Store below 25°C in a tightly closed container, protected from moisture and light |
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR, UV, and HPLC analysis 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 | 0.35 – 0.50 g/mL |
| Tapped Density | 0.50 – 0.65 g/mL |
Applications
Risperidone API is used in:
- Oral tablets (immediate and extended-release)
- Orally disintegrating tablets for pediatric use
- Oral suspensions for flexible dosing
- Combination formulations for psychiatric disorders
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 Pack Sizes: 1 kg | 5 kg | 10 kg | 25 kg HDPE drums with double poly liners
- Labeling: Batch number, manufacturing & expiry dates, storage instructions, and net weight
- Shelf Life: 36 months under recommended storage conditions
- Export Markets: Africa, Asia, Latin America, Europe, Middle East
