Description

Amifampridine Phosphate CAS NO 446254-47-3 is a high-purity, small-molecule pharmaceutical intermediate and active ingredient. It is a potassium channel blocker of significant commercial and therapeutic importance, primarily used in the development and manufacture of treatments for neurological disorders. This compound is essential for pharmaceutical companies, research institutions, and contract manufacturing organizations (CMOs) focused on neurology and rare diseases. We supply it under stringent quality control to ensure batch-to-batch consistency for critical applications.

Application

• Pharmaceutical Active Ingredient (API): Primary use in the formulation of treatments for Lambert-Eaton Myasthenic Syndrome (LEMS) and other neuromuscular junction disorders.
• Neurological Research: A key tool compound in preclinical and clinical research for studying potassium channel function and synaptic transmission.
• Reference Standard: Serves as a certified reference material (CRM) for quality control and analytical method development in pharmaceutical laboratories.
• Process Development: Used in the scale-up and optimization of synthetic routes for amifampridine-based therapeutics.
• Formulation Studies: Employed in the development of various dosage forms, including tablets and oral solutions.
• Contract Manufacturing: Supplied to CMOs for the production of finished drug products under cGMP guidelines.

Basic Information

Product Name	Amifampridine Phosphate
CAS No.	446254-47-3
Molecular Formula	C11H13N3O4P
Molecular Weight	282.21 g/mol
Synonyms	3,4-Diaminopyridine Phosphate; 3,4-DAP Phosphate; Amifampridine (as phosphate salt); Firdapse (active moiety); Potassium Channel Blocker; Zenas; 4-Amino-3-pyridinamine phosphate; 3,4-Diaminopyridine, phosphate (1:1)
EINECS	Contact for details

Quality Control

Our Amifampridine Phosphate is manufactured and tested to meet the stringent requirements of pharmaceutical applications. Quality is assured through a comprehensive analytical control strategy, including HPLC for purity, residual solvent analysis, and stringent limits for related substances. A Certificate of Analysis (COA) is provided with each batch, detailing compliance with in-house specifications aligned with ICH guidelines. We support audits and can supply material manufactured under cGMP conditions for advanced clinical and commercial use.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccant use and inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Total impurities ≤ 1.0%; Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C Class 2 & 3 limits
Heavy Metals	≤ 20 ppm
pH (1% solution)	3.0 - 5.0

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.