RISPERIDONE

Risperidone API is a highly effective atypical antipsychotic used in the treatment of schizophrenia, bipolar I disorder, and irritability associated with autism spectrum disorder. It acts as a dopamine D₂ and serotonin 5-HT₂ receptor antagonist, offering a balanced efficacy with a lower risk of extrapyramidal side effects compared to conventional antipsychotics.

At Bluepill Express, we manufacture and export Risperidone Active Pharmaceutical Ingredient (API) under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities. Our manufacturing process ensures high assay purity (≥99.0%), excellent stability, and low residual solvent levels, meeting global pharmacopeial standards (IP/BP/USP/EP).

Risperidone’s unique receptor-binding profile provides effective symptom control for both positive and negative symptoms of schizophrenia and mood disorders. Its long half-life allows once-daily dosing and stable therapeutic plasma concentrations.

Therapeutic Applications:

• Schizophrenia (acute and chronic phases)
• Bipolar I disorder (manic and mixed episodes)
• Irritability and aggression in autism spectrum disorders
• Delusional disorders and behavioral disturbances in dementia

Mechanism of Action:

Risperidone acts as a dual antagonist at serotonin 5-HT₂A and dopamine D₂ receptors, restoring the balance of neurotransmitters in the brain. This dual mechanism reduces psychotic symptoms and mood instability while minimizing extrapyramidal symptoms (EPS) and prolactin elevation commonly associated with older antipsychotics.

Technical Specifications:

• Chemical Name: 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-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
• Appearance: White to off-white crystalline powder
• Assay (on dried basis): NLT 99.0% and NMT 101.0%
• Solubility: Practically insoluble in water; soluble in methanol and acetonitrile
• Storage Conditions: Store below 25°C, protected from light and moisture

Pharmacological Classification:

• Therapeutic Class: Atypical Antipsychotic
• Pharmacopoeial Standards: IP / BP / USP / EP
• Dosage Form Applications:
  • Oral tablets (1 mg, 2 mg, 3 mg, 4 mg, 6 mg)
  • Oral solutions and suspensions
  • Long-acting injectable formulations (Risperidone microspheres or depot forms)

Manufacturing & Quality Standards – Bluepill Express:

• Manufactured under WHO-GMP, ISO 9001:2015, and cGMP-compliant facilities
• High purity API (≥99%) with excellent crystallinity
• Tested using HPLC, FTIR, and NMR to ensure identity and quality
• Low impurity profile and residual solvent levels as per ICH Q3C
• Full COA, MSDS, and DMF documentation available for regulatory submissions
• Stability-tested API suitable for global climatic zones (Zone I–IVb)

Advantages of Bluepill Express Risperidone API:

• High assay value (≥99%) ensuring consistent formulation quality
• Low moisture content for long-term stability
• DMF-ready documentation supporting regulatory filings
• Batch-to-batch consistency for uniform performance
• Complies with global pharmacopeial requirements (IP/BP/USP/EP)

Packaging & Export Details:

• Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE drums with double LDPE liners
• Shelf Life: 3 years under recommended storage conditions
• Labeling: As per pharmacopeial and international guidelines
• Export Markets: Europe, Africa, Latin America, Middle East, Southeast Asia
• Documentation Provided:
  • Certificate of Analysis (COA)
  • Material Safety Data Sheet (MSDS)
  • Drug Master File (DMF – on request)
  • Stability Studies and Validation Data