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Pramipexole Dihydrochloride Monohydrate is a selective dopamine D2/D3 receptor agonist used primarily for the treatment of Parkinson’s disease (PD) and Restless Legs Syndrome (RLS). It mimics the action of dopamine in the brain, helping to restore motor function, reduce tremors, rigidity, and bradykinesia, and improve overall quality of life in patients with dopaminergic deficits.
At Bluepill Express, we manufacture and export pharmaceutical-grade Pramipexole Dihydrochloride Monohydrate API that adheres to IP, BP, USP, and EP pharmacopeial standards. Produced under WHO-GMP, ISO, and cGMP-certified facilities, our API ensures high purity, stable crystalline form, and consistent particle size, making it suitable for tablets, extended-release capsules, and combination formulations.
Each batch is analytically validated for assay, impurity profile, moisture content, and stability, making it an ideal choice for global pharmaceutical manufacturers.
Pharmacological Information:
- Therapeutic Class: Anti-Parkinson Agent / Dopamine Agonist
- Pharmacological Category: Non-Ergot Dopamine Agonist
- CAS Number: 104632-26-0
- Molecular Formula: C10H17Cl2N3S·H2O
- Molecular Weight: 302.24 g/mol
- Appearance: White to off-white crystalline powder
- Solubility: Freely soluble in water, sparingly soluble in ethanol
- Melting Point: 222°C – 224°C (decomposes)
- Storage: Store in a tightly closed container, below 25°C, in a cool, dry place
Mode of Action:
Pramipexole directly stimulates dopamine D2 and D3 receptors in the striatum, mimicking the effects of dopamine. This enhances dopaminergic neurotransmission, improving motor control in Parkinson’s disease and reducing sensory-motor symptoms in Restless Legs Syndrome.
Applications and Uses:
- Parkinson’s Disease (PD) – Monotherapy or adjunct to Levodopa for improved motor control
- Restless Legs Syndrome (RLS) – Reduces nighttime discomfort and improves sleep quality
- Off-Label Uses – May be used in combination therapy for dopamine-related movement disorders
Technical Specifications:
- Assay (Purity): ≥ 99.5%
- Identification: IR spectrum matches reference standard
- Loss on Drying: ≤ 0.5%
- Residue on Ignition: ≤ 0.1%
- Heavy Metals: ≤ 10 ppm
- Related Substances: ≤ 0.2% (individual impurity)
- Particle Size: Controlled for uniformity and dissolution
- Microbial Limits: Complies with pharmacopeial standards
Manufacturing & Quality Assurance – Bluepill Express:
- Produced under WHO-GMP and ISO-certified facilities
- High-purity crystalline form with stable monohydrate content
- COA, MSDS, and TDS provided for each batch
- HPLC-tested for assay and impurity profile
- Pharmacopeial compliance: IP / BP / USP / EP
- Suitable for tablets, capsules, and combination formulations
Packaging & Export Details:
- Available Packs: 1 kg, 5 kg, 10 kg, 25 kg HDPE drums with inner liner
- Shelf Life: 36 months from manufacturing date
- Labeling: Export-compliant with batch number and origin
- Export Markets: Africa, Asia, Europe, Middle East, Latin America
- Documentation Provided:
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Stability Data (on request)
- Non-GMO and Allergen-Free Declarations
