Nalidixic Acid is a synthetic quinolone antibacterial active pharmaceutical ingredient (API) with activity against susceptible Gram-negative bacteria. It is an early-generation quinolone antibacterial compound that acts primarily by interfering with bacterial DNA replication.
Nalidixic Acid is used as a pharmaceutical API for formulation development, antibacterial research and analytical applications.
Nalidixic Acid is a well-characterized antibacterial pharmaceutical API used in the development and manufacture of pharmaceutical formulations and in microbiological research.
Important API quality attributes include identity, assay, related substances, water content, residue on ignition, residual solvents and other applicable pharmaceutical quality parameters.
CAS Number: 389-08-2
Molecular Formula: C12H12N2O3
Molecular Weight: 232.24 g/mol
Chemical Name: 1-Ethyl-7-methyl-4-oxo-1,8-naphthyridine-3-carboxylic acid
Drug Class: Quinolone Antibacterial
Therapeutic Class: Antibacterial
Therapeutic Area: Infectious Diseases
Molecule Type: Synthetic Small Molecule
Nalidixic Acid primarily inhibits bacterial DNA gyrase, an enzyme required for bacterial DNA replication and chromosome organization.
Its antibacterial activity includes:
Nalidixic Acid is considered an early quinolone and has a narrower antibacterial spectrum than later-generation fluoroquinolones.
Nalidixic Acid API is relevant to:
Nalidixic Acid has historically been associated with the treatment of susceptible urinary tract infections, particularly infections caused by certain Gram-negative bacteria.
Its use is limited by bacterial resistance and by the availability of newer antibacterial agents. Current therapeutic applications should therefore be determined according to applicable regulatory approvals and clinical guidelines.
Nalidixic Acid is generally described as a white to pale yellow crystalline powder. It is practically insoluble in water and has greater solubility in alkaline conditions due to its acidic carboxyl group.
Physical and chemical characteristics should be controlled according to the applicable pharmaceutical specification.
A controlled Nalidixic Acid API manufacturing process may involve:
Typical Nalidixic Acid API testing may include:
Store Nalidixic Acid API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light.
Final storage conditions should be established according to validated stability data and the applicable API specification.
Nalidixic Acid is relevant to research involving:
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | 229–231°C |
| Solubility | Practically insoluble in water; soluble in alkaline solutions |