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Rasagiline Tartrate is a selective, irreversible monoamine oxidase-B (MAO-B) inhibitor, widely used in the management of Parkinson’s disease. It helps in increasing dopamine levels in the brain, improving motor function, and slowing the progression of neurodegenerative symptoms.
At Bluepill Express, we manufacture high-purity Rasagiline Tartrate API under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities. Our API meets IP/BP/USP/EP standards and is trusted globally for its purity, stability, and therapeutic efficacy.
Therapeutic Uses
- Treatment of Parkinson’s disease (early and adjunct therapy)
- Improves motor control and reduces “off” episodes in patients on levodopa
- Neuroprotective properties may slow disease progression
- Used as monotherapy or in combination with other anti-Parkinson drugs
Mechanism of Action
Rasagiline selectively and irreversibly inhibits monoamine oxidase-B (MAO-B), the enzyme responsible for the breakdown of dopamine in the central nervous system.
Key effects include:
- Increased synaptic dopamine availability
- Improved neuronal communication and motor function
- Minimal inhibition of MAO-A at therapeutic doses, reducing dietary restrictions
Pharmacological Information
| Parameter | Details |
|---|---|
| Chemical Name | (R)-N-propargyl-1-aminoindan L-tartrate (1:1) |
| Molecular Formula | C12H15N·C4H6O6 |
| Molecular Weight | 241.27 g/mol |
| CAS Number | 104632-26-0 |
| Therapeutic Category | Anti-Parkinson / MAO-B Inhibitor |
| Pharmacopoeial Standards | IP / BP / USP / EP |
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to off-white crystalline powder |
| Odor | Odorless |
| Melting Point | 120°C – 123°C |
| Solubility | Soluble in water, methanol; slightly soluble in ethanol |
| Assay (on dried basis) | 98.0% – 102.0% |
| pH (1% solution) | 4.5 – 6.0 |
Technical Specifications
| Test | Specification |
|---|---|
| Appearance | White crystalline powder |
| Identification | IR / HPLC – Complies |
| Assay (Purity) | 98.0% – 102.0% |
| Loss on Drying | ≤ 1.0% |
| Residue on Ignition | ≤ 0.1% |
| Related Substances | ≤ 0.3% (individual), ≤ 0.5% (total) |
| Heavy Metals | ≤ 10 ppm |
| Storage | Store below 25°C in airtight container, away from light and moisture |
Applications
- Formulation of oral tablets for Parkinson’s disease
- Monotherapy for early-stage Parkinson’s patients
- Adjunct therapy to levodopa in advanced cases
- Suitable for generic and branded formulations globally
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Stability Data (ICH guidelines)
- Drug Master File (DMF) – available on request
Packaging & Export Details
| Packaging Type | Net Weight |
|---|---|
| HDPE Drum | 25 kg |
| Fiber Drum | 25 kg |
| LDPE Inner Bag | 1 kg / 5 kg / 10 kg |
Labeling Includes: Product name, batch number, manufacturing & expiry date, net weight, storage instructions.
Shelf Life: 5 years (stored below 25°C)
Export Markets: Africa, Middle East, Asia, Europe, and Latin America
