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Amantadine sulfate
Pharmaceutical Chemistry

Amantadine sulfate

Formula: C10H17N GOST/CAS: CAS 31377-23-8

Amantadine sulfate is a highly effective chemical component acting as a symmetrical adamantane derivative. It serves as a key Active Pharmaceutical Ingredient (API) with pronounced antiviral and dopaminergic activity. The product is a fine crystalline powder, highly soluble in water and alcohol. Due to its ability to block ion channels and stimulate dopamine release, amantadine sulfate is indispensable in the formulation of finished dosage forms (tablets, solutions for infusion) for the treatment of neurological diseases and viral infections.

Applications

Production of Antiparkinsonian Drugs: Used as a baseline component in the manufacturing of drugs designed to treat Parkinson's disease and parkinsonism syndromes of various etiologies. It helps alleviate tremor, rigidity, and hypokinesia.
Neurology and Intensive Care: Applied in the production of infusion solutions for the complex therapy of traumatic brain injuries, prolonged recovery from anesthesia, and improving vigilance levels in comatose states.
Antiviral Pharmaceuticals: Included in formulations of medicinal products aimed at the prevention and treatment of Influenza A. It effectively blocks viral replication at the early stages.
Research and Development (R&D): Utilized in laboratory practices and the synthesis of other adamantane derivatives to study their effects on the glutamatergic and dopaminergic systems.

Key Advantages

High Therapeutic Purity: The substance features a strictly controlled minimal level of impurities, ensuring a stable pharmacological response and ultimate safety in the production of finished dosage forms.
Excellent Processability: The powder exhibits optimal flowability and a stable particle size distribution, minimizing risks during tablet compression and encapsulation processes.
Stability and Compatibility: Maintains its physical and chemical properties across a wide temperature range and demonstrates excellent compatibility with standard pharmaceutical excipients (fillers, binders).
High Solubility: Dissolves rapidly and completely in liquid media, significantly simplifying the preparation process of sterile solutions for infusion.

Storage & Transportation

  • Store in dry, cool, light-protected, and well-ventilated warehouse premises in tightly sealed original packaging.
  • Recommended storage temperature: from +15 C to $+25 C. Avoid sudden temperature fluctuations and high humidity (the product is hygroscopic).
  • Keep isolated from strong oxidizing agents, acids, and food products.
  • Transportation is permitted by all modes of covered transport in strict compliance with temperature regimes and standard regulations for pharmaceutical raw materials. Guaranteed shelf life is 3 years from the date of manufacture.

Technical Specifications

Appearance White or almost white crystalline powder
Molecular Weight 400.59 g/mol
Assay (Main Substance) ≥ 99.0% (on dry basis)
Melting Point >300 C (with decomposition)
pH (5% aqueous solution) 5.5 – 7.0
Loss on Drying ≤ 0.5%

Supply info

  • Double polyethylene bags packed in airtight fibre drums of 25 kg (standard industrial packaging).
  • Custom small-scale packaging of 1 kg and 5 kg is available for R&D laboratories and pilot-scale productions.
  • Each shipment is accompanied by a full documentation package: Certificate of Analysis (CoA), MSDS, and Registration Certificate (where applicable).

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