Dalfampridine, also known as 4-aminopyridine (4-AP), is a potassium channel blocker used to improve walking in patients with multiple sclerosis (MS). It works by enhancing conduction in demyelinated nerves, thus improving neuromuscular function.
Marketed under the brand name Ampyra® (US) or Fampyra® (EU), dalfampridine is available as extended-release oral tablets and is typically prescribed only for adult MS patients.
Clinical uses include:
∙ Improving walking speed and gait in adults with multiple sclerosis
∙ Investigational uses in spinal cord injury and other demyelinating conditions
Parent: Dalfampridine
Parent: Dalfampridine
Parent: Dalfampridine
Parent: Dalfampridine
Impurities in dalfampridine may originate from its simple synthetic process, which typically involves nitration, reduction, and amine purification. Impurity levels must comply with ICH Q3A/B, USP, and EP standards to ensure patient safety.
Process-Related Impurities
Degradation Impurities
Elemental Impurities
Analytical Techniques for Impurity Detection
UV-Vis and IR spectroscopy – for structural verification and quality control
It is used to improve walking ability in patients with multiple sclerosis (MS) by facilitating signal transmission in damaged nerves.
It blocks voltage-gated potassium channels, which prolongs action potential conduction in demyelinated axons, improving muscle coordination.
Yes. The risk increases at high blood levels or impaired renal function. It is contraindicated in patients with a history of seizures or moderate to severe renal impairment.
Store at room temperature, away from moisture and heat. Tablets should be kept in their original container and not crushed, chewed, or divided, as this affects release properties.
