Category
Amifampridine
CAS Number
1805397-64-1
Molecular Formula
C₅H₄N₄O₄
Molecular Weight
184.1 g/mol
Synonym

2,3-Dinitropyridin-4-amine ; 

Keywords
Fine Chemicals
Heterocycles
Intermediates
Impurities manufacturer and Suppliers in Hyderabad india
Slide_1
Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

Amifampridine Impurity 1 (CAS No. 1805397-64-1) is a high-purity pharmaceutical impurity reference standard with molecular formula C₅H₄N₄O₄ and molecular weight 184.1 g/mol, widely used in drug impurity profiling, analytical method development, and quality control testing. It is essential for the identification, characterization, and quantification of trace-level impurities in Amifampridine active pharmaceutical ingredients and finished dosage forms. This impurity standard is routinely applied in HPLC, LC-MS/MS, and GC-MS techniques for stability studies, analytical validation, and pharmaceutical research applications. It also supports regulatory compliance for impurity control and drug safety assessment in accordance with global standards such as ICH  guidelines for impurities, US FDA regulatory requirements, and EMA quality guidelines. Supplied by Manasa Life Sciences, Amifampridine Impurity 1 is provided with complete CoA, SDS, and MSDS documentation, ensuring high purity, traceability, and reliable analytical performance for regulated laboratory use.