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Olanzapine is a second-generation (atypical) antipsychotic used for the treatment of schizophrenia, bipolar disorder, and other psychotic disorders. It works by modulating the activity of dopamine (D2) and serotonin (5-HT2A) receptors in the brain, helping to restore chemical balance and reduce symptoms such as hallucinations, delusions, mood swings, and agitation.
Bluepill Express manufactures high-purity Olanzapine API under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities, ensuring consistent quality, stability, and compliance with IP, BP, USP, and EP standards. This API is suitable for tablet and oral formulations, catering to both domestic and international pharmaceutical markets.
Therapeutic Uses
- Schizophrenia: Reduces hallucinations, delusions, and cognitive symptoms
- Bipolar Disorder: Manages manic and mixed episodes; maintenance therapy
- Adjunct Therapy: Can be combined with mood stabilizers for improved efficacy
- Agitation and Psychotic Symptoms: Provides rapid symptom relief
- Long-term Mental Health Management: Helps maintain psychiatric stability
Mechanism of Action
Olanzapine primarily acts by:
- Dopamine D2 receptor antagonism: Reduces psychotic symptoms
- Serotonin 5-HT2A receptor antagonism: Improves mood and cognitive function
- Moderate antagonism of other neurotransmitter receptors: Contributes to sedative and anxiolytic effects
- Balances neurotransmission to stabilize mood and psychotic episodes
Pharmacological Information
- Chemical Name: 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine
- Molecular Formula: C17H20N4S
- Molecular Weight: 312.44 g/mol
- CAS Number: 132539-06-1
- Therapeutic Class: Antipsychotic / Atypical
- Pharmacological Class: CNS Agent / Dopamine-Serotonin Modulator
- ATC Code: N05AH03
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to off-white crystalline powder |
| Solubility | Soluble in methanol and chloroform; slightly soluble in water |
| Melting Point | 197°C – 198°C |
| pH (1% aqueous solution) | 5.0 – 6.0 |
| Storage | Store below 25°C in a dry, ventilated area, protected from light and moisture |
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR, UV, and HPLC 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
Olanzapine API is used in:
- Tablet and oral formulations for schizophrenia and bipolar disorder
- Combination therapy with mood stabilizers or adjunctive CNS agents
- Bulk API supply for domestic and international pharmaceutical markets
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 Packs: 1 kg | 5 kg | 10 kg | 25 kg HDPE drums with double poly liners
- Labeling: Product name, batch number, manufacturing/expiry dates, storage instructions
- Shelf Life: 36 months under recommended storage conditions
- Export Markets: Africa, Asia, Latin America, Europe, Middle East
