Fampridine API Manufacturer & Supplier in India

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Fampridine API Manufacturer & Supplier in India

Fampridine is a synthetic small-molecule potassium channel blocker and active pharmaceutical ingredient (API). It is also known as 4-aminopyridine (4-AP) and is used to improve walking ability in certain adults with multiple sclerosis (MS).

Fampridine works by blocking voltage-gated potassium channels on demyelinated nerve fibers, helping improve the conduction of electrical signals along affected nerves.

What is Fampridine?

Fampridine is a 4-aminopyridine derivative that acts primarily by blocking voltage-gated potassium channels. In demyelinated axons, this mechanism can help restore or improve action-potential conduction.

CAS Number: 504-24-5
Molecular Formula: C₅H₆N₂
Molecular Weight: 94.12 g/mol

Mechanism of Action

Fampridine blocks voltage-gated potassium channels in neuronal membranes.

Its pharmacological effects include:

  • Blockade of voltage-gated potassium channels
  • Reduction of potassium ion efflux from neurons
  • Prolongation of action potentials
  • Improvement of conduction through demyelinated axons
  • Potential enhancement of neurological signal transmission

Pharmaceutical Applications

Fampridine is used in pharmaceutical formulations for:

  • Improving walking ability in adults with multiple sclerosis
  • Symptomatic management of walking impairment associated with MS

The exact indication, dosage and patient eligibility depend on the approved formulation and applicable regulatory labeling.

Fampridine API

Fampridine is a small-molecule pharmaceutical API with defined chemical and physicochemical characteristics. Pharmaceutical-grade material requires appropriate control of identity, assay, related substances and other quality attributes.

Typical quality evaluation may include:

  • Identification
  • Assay
  • Related substances
  • Water content
  • Residual solvents
  • Elemental impurities
  • Melting point
  • Particle-size characteristics, where applicable

Quality & Regulatory Considerations

Pharmaceutical-grade Fampridine should comply with the applicable approved specification and relevant regulatory requirements.

A qualified supplier should provide Certificate of Analysis (CoA), specification sheet, SDS/MSDS, batch traceability and applicable regulatory documentation.

Storage

Store Fampridine in a tightly closed container, protected from excessive moisture, heat and direct light, according to the manufacturer's approved storage and stability requirements.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 20 ppm
pH (1% Solution) 5.5 – 6.5
Individual Impurity NMT 1.0%
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