Home APIsARIPIPRAZOLE

ARIPIPRAZOLE

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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

ParameterDetails
Chemical Name7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril
Molecular FormulaC23H27Cl2N3O2
Molecular Weight448.38 g/mol
CAS Number129722-12-9
Therapeutic CategoryAntipsychotic
Pharmacopoeial StatusUSP / EP / IP Compliant

Physical & Chemical Properties

PropertySpecification
AppearanceWhite to off-white crystalline powder
SolubilityInsoluble in water, freely soluble in chloroform and methanol
Melting Point139°C – 144°C
Optical RotationNeutral
StorageStore below 25°C, in a dry and dark place
OdorOdorless

Technical Specifications (Typical Bluepill Express Standard)

ParameterSpecification
IdentificationPositive 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 SizeD90 < 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

DetailDescription
Available Packs1 kg / 5 kg / 10 kg / 25 kg HDPE or Fiber Drums with double poly liner
LabelingProduct name, batch number, MFG/EXP date, storage conditions
Shelf Life3–5 years (under controlled conditions)
Export MarketsAfrica, 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)

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