Active Pharmaceutical Ingredient

Amifampridine

Also known as: Firdapse / 3,4-DAP

CAS: 54-96-6 K⁺ Channel Blocker / Neurology EP Standard Rare Disease API
Amifampridine API Manufacturer India | Mediocon Inc
Amifampridine — Pharmaceutical Grade API

Product Overview

CAS No: 54-96-6  |  MF: C₅H₇N₃  |  MW: 109.13 g/mol

Amifampridine (3,4-diaminopyridine) is a potassium channel blocker used in the treatment of Lambert-Eaton myasthenic syndrome (LEMS). It enhances acetylcholine release at the neuromuscular junction. Mediocon Inc supplies pharmaceutical-grade Amifampridine for rare disease and specialty neurological manufacturers.

Key Features

  • Potassium channel blocker for LEMS
  • EP compliant quality
  • Enhances neuromuscular transmission
  • Approved for rare neuromuscular disease

Applications

  • Lambert-Eaton myasthenic syndrome tablets
  • Neuromuscular disease management
  • Rare disease specialty formulations
  • Congenital myasthenic syndrome

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameAmifampridine
Also Known AsFirdapse / 3,4-DAP
CAS Number54-96-6
Molecular FormulaC₅H₇N₃
Molecular Weight109.13 g/mol
CategoryPotassium Channel Blocker / Neurology
AppearanceWhite to Off-white Powder
GradeEP / In-house GMP Standard

Analytical Specifications

ParameterSpecification
Assay98.0% – 101.0%
Loss on DryingNMT 1.0%
Melting Point215°C – 220°C
Heavy MetalsNMT 10 ppm
pHN/A
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing1 kg foil pouches / as per requirement
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