Overview
Risperidone (CAS 106266-06-2 ) is an atypical antipsychotic active pharmaceutical ingredient used in the manufacture of finished-dose psychiatric medications. As a controlled API, it is sourced by pharmaceutical manufacturers and contract formulators for integration into regulated drug products.
Risperidone is the active ingredient in oral solid-dose formulations, including tablets and oral solutions, indicated for schizophrenia and bipolar disorder treatment. Risperdal Consta represents a distinct extended-release injectable microsphere formulation.
This specific application requires specialized excipient systems and cold-chain handling that procurement teams must account for during sourcing. Generic pharmaceutical manufacturers source the API to produce bioequivalent products following patent expiry.
This makes the compound an active target for ANDA and generic dossier development. Contract development and manufacturing organizations also use it as a reference compound in formulation feasibility and dissolution testing programs.
The material is supplied as a white to off-white crystalline powder. It is available in pharmaceutical-grade specifications conforming to USP , BP , and Ph. Eur. monographs for global compliance.
Documentation packages typically include CoA, DMF references, and ICH-compliant impurity profiles. Quantities range from research-scale grams to commercial multi-kilogram batches depending on supplier capability and production requirements.
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Physical Properties
| Melting Point | 170 °C |
| Boiling Point | 572.4±60.0 °C(Predicted) |
| Density | 1.38±0.1 g/cm3(Predicted) |
| Flash Point | 9°C |
| Appearance | Crystalline Solid |
| Color | white to off-white |
| Form | powder |
| Water Solubility | 44.74mg/L(25 ºC) |
Safety & Handling
Danger GHS06 GHS08 GHS09 Hazard Statements H301 Toxic if swallowed H331 Toxic if inhaled H351 Suspected of causing cancer H411 Toxic to aquatic life with long lasting effects Precautionary Statements P203 Obtain, consult and follow expert instructions for use. P261 Avoid breathing dust/fume/gas/mist/vapours/spray. P264 Wash … thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P271 Use only outdoors or in a well-ventilated area. P273 Avoid release to the environment. P280 Wear protective gloves/protective clothing/eye protection/face protection. P316 Get emergency medical help immediately. P318 IF exposed or concerned, get medical advice. P321 Specific treatment (see … on this label). P330 Rinse mouth. P391 Collect spillage. P405 Store locked up. P501 Dispose of contents/container in accordance with local regulations. P301+P316 Get emergency medical help immediately. P304+P340 IF INHALED: Remove person to fresh air and keep comfortable for breathing. P403+P233 Store in a well-ventilated place. Keep container tightly closed.
Trade & Regulatory
| HS Code | 29349900 |
| Storage Class | 6.1C - Combustible acute toxic Cat.3 toxic compounds or compounds which causing chronic effects |
| WGK (Germany) | 3 |
Other Names
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Chemical Properties
- CAS Number
- 106266-06-2
- EC Number
- 600-733-1
- Mol. Weight
- 410.5
- HS Code
- 29349900
- Category
- Pharmaceutical Intermediates