Aripiprazole is an atypical antipsychotic API widely used in the treatment of schizophrenia, bipolar disorder, major depressive disorder, and autism-related irritability.
It acts as a partial agonist at dopamine D2 and serotonin 5-HT1A receptors and an antagonist at 5-HT2A receptors, offering a unique pharmacological profile with fewer side effects than typical antipsychotics.
At Bluepill Express, Aripiprazole is manufactured under WHO-GMP and cGMP-certified facilities, ensuring superior purity, precise particle size distribution, and global regulatory compliance.
Therapeutic Category
- Antipsychotic (Atypical)
- Mood Stabilizer
- Antidepressant Adjunct
Mechanism of Action
Aripiprazole works by modulating dopamine and serotonin activity in the brain.
It functions as a dopamine-serotonin system stabilizer, balancing neurotransmission to alleviate symptoms such as hallucinations, delusions, mood swings, and depression. This mechanism results in effective symptom control with minimal extrapyramidal side effects.
Chemical Information
| Parameter | Details |
|---|---|
| Chemical Name | 7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril |
| Molecular Formula | C23H27Cl2N3O2 |
| Molecular Weight | 448.38 g/mol |
| CAS Number | 129722-12-9 |
| Therapeutic Category | Antipsychotic |
| Pharmacopoeial Status | USP / EP / IP Compliant |
Physical & Chemical Properties
| Property | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Solubility | Insoluble in water, freely soluble in chloroform and methanol |
| Melting Point | 139°C – 144°C |
| Optical Rotation | Neutral |
| Storage | Store below 25°C, in a dry and dark place |
| Odor | Odorless |
Technical Specifications (Typical Bluepill Express Standard)
| Parameter | Specification |
|---|---|
| Identification | Positive by IR/UV |
| Assay (Purity) | ≥ 99.0% (HPLC) |
| Related Substances | ≤ 0.3% individual impurity |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 10 ppm |
| Particle Size | D90 < 50 µm (Micronized grade available) |
| pH (1% solution) | 6.0 – 7.5 |
Pharmacological Applications
- Schizophrenia: Reduces positive and negative symptoms with lower sedation and metabolic side effects.
- Bipolar Disorder: Stabilizes mood swings and prevents manic or depressive episodes.
- Major Depressive Disorder (Adjunct): Enhances antidepressant efficacy when used with SSRIs or SNRIs.
- Autism Spectrum Disorder: Helps control irritability, aggression, and repetitive behavior.
Packaging & Export Details
| Detail | Description |
|---|---|
| Available Packs | 1 kg / 5 kg / 10 kg / 25 kg HDPE or Fiber Drums with double poly liner |
| Labeling | Product name, batch number, MFG/EXP date, storage conditions |
| Shelf Life | 3–5 years (under controlled conditions) |
| Export Markets | Africa, Middle East, CIS, South America, and Asia Pacific |
Documentation Supplied
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Stability Data (as per ICH Q1A)
- Regulatory Support (DMF/CTD on request)
