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Amantadine Hydrochloride is a synthetic tricyclic amine that serves a dual role as an antiviral medication and anti-Parkinsonian agent. It was initially developed for the treatment and prevention of influenza A virus infections, but it is now widely used for the management of Parkinson’s disease and drug-induced extrapyramidal symptoms (EPS).
At Bluepill Express, we manufacture and export high-purity Amantadine Hydrochloride API that meets IP, BP, USP, and EP pharmacopeial specifications. Our API is produced under WHO-GMP-certified facilities, ensuring exceptional purity, consistent particle size, and superior stability, suitable for both solid and liquid dosage formulations.
Amantadine works by blocking the M2 ion channel of influenza A viruses, inhibiting viral replication within host cells. In Parkinson’s therapy, it acts as a dopamine releaser and NMDA receptor antagonist, improving motor function, rigidity, and tremor. This dual mechanism of action makes Amantadine Hydrochloride an essential pharmaceutical ingredient in both neurological and antiviral therapies.
Pharmacological Information:
- Therapeutic Category: Antiviral / Anti-Parkinsonian
- Pharmacological Class: Adamantane derivatives
- CAS Number: 665-66-7
- Molecular Formula: C10H17N·HCl
- Molecular Weight: 187.71 g/mol
- Appearance: White or almost white crystalline powder
- Odor: Odorless
- Solubility: Freely soluble in water, slightly soluble in ethanol
- pH (1% solution): 6.0 – 7.5
- Storage Conditions: Store below 25°C, in a tightly sealed container, protected from light and moisture
- Shelf Life: 36 months under recommended storage
Mechanism of Action:
- Antiviral Effect:
Amantadine blocks the M2 proton channel of the influenza A virus, preventing uncoating of viral RNA within the host cell. This inhibits viral replication and limits infection spread. - Anti-Parkinsonian Effect:
Amantadine enhances dopaminergic neurotransmission by promoting dopamine release and inhibiting its reuptake in the brain. Additionally, it blocks N-methyl-D-aspartate (NMDA) receptors, reducing glutamate-induced excitotoxicity, improving mobility and tremor control in Parkinson’s patients.
Applications and Uses:
- Treatment and prophylaxis of Influenza A infections
- Adjunct therapy in Parkinson’s disease
- Management of drug-induced extrapyramidal reactions (EPS)
- Neurological research and formulation development
Formulation Applications:
- Amantadine Hydrochloride Tablets (100 mg / 200 mg)
- Amantadine Syrup (10 mg/mL)
- Amantadine Capsules
- Combination Therapy:
- Amantadine + Levodopa + Carbidopa
- Amantadine + Trihexyphenidyl Hydrochloride
Technical Specifications:
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder |
| Identification | IR spectrum matches reference standard |
| Assay (on dried basis) | 98.0% – 102.0% |
| Melting Point | 242°C – 246°C (decomposition) |
| Water Content (KF) | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 10 ppm |
| Chloride Test | Positive |
| Loss on Drying | ≤ 0.5% |
| pH (1% solution) | 6.0 – 7.5 |
| Related Substances | ≤ 0.5% (individual impurity ≤ 0.2%) |
| Microbial Limits | Complies with pharmacopeial standards |
Quality Assurance & Manufacturing Standards – Bluepill Express
At Bluepill Express, we uphold strict quality control (QC) and quality assurance (QA) standards to ensure the highest-grade Amantadine Hydrochloride API production.
All manufacturing processes are conducted in cleanroom environments under GMP, ISO 9001:2015, and cGMP-certified facilities.
Each batch undergoes analytical testing using:
- HPLC (High-Performance Liquid Chromatography) for assay and impurities
- FTIR spectroscopy for identification
- Karl Fischer titration for moisture determination
- Residual solvent analysis (GC method)
Every shipment is accompanied by comprehensive documentation including:
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Stability Data (on request)
- Non-GMO and BSE/TSE-Free Certificates
Packaging & Export Details:
- Available Packaging Sizes: 1 kg / 5 kg / 10 kg / 25 kg HDPE drums with inner poly liners
- Labeling: Compliant with global regulatory standards
- Shelf Life: 36 months from manufacturing date
- Export Documentation Provided: COA, MSDS, TDS, Stability Data, Free Sale Certificate
Export Destinations:
Bluepill Express exports Amantadine Hydrochloride API across Asia, Africa, Europe, Latin America, and the Middle East, ensuring compliance with country-specific regulatory norms.
Regulatory Compliance:
- Pharmacopeial Compliance: IP / BP / USP / EP
- GMP Certification: WHO-GMP, ISO 9001:2015
- ICH Q7 & Q3C Guidelines: Fully Compliant
- BSE/TSE-Free: Confirmed
- Residual Solvents: Within ICH limits
Safety Information:
- Hazard Class: Non-hazardous under normal handling conditions
- Precautions: Avoid inhalation and direct contact; use gloves and eye protection during handling
- First Aid: Rinse with water in case of skin or eye contact
- Storage: Store in a cool, dry place away from light and humidity
