Isoconazole Nitrate is a synthetic imidazole antifungal agent used for the treatment of superficial fungal infections of the skin. It exhibits broad-spectrum antifungal activity against various dermatophytes, yeasts and other susceptible fungi.
Isoconazole Nitrate acts primarily by inhibiting the fungal enzyme lanosterol 14α-demethylase, interfering with ergosterol biosynthesis and disrupting the fungal cell membrane.
Isoconazole Nitrate is a specialized azole antifungal pharmaceutical API manufactured through controlled chemical synthesis, purification and crystallization processes.
Quality evaluation focuses on identity, assay, related substances, residual solvents, water content, inorganic impurities, particle characteristics and stability.
CAS Number: 24168-96-5
Molecular Formula: C18H14Cl4N2O · HNO3
Molecular Weight: 479.14 g/mol
Drug Class: Antifungal Agent
Pharmacological Class: Imidazole Antifungal
Therapeutic Class: Antifungal
Therapeutic Area: Dermatology / Infectious Diseases
Isoconazole inhibits lanosterol 14α-demethylase, a cytochrome P450-dependent enzyme involved in the biosynthesis of ergosterol.
Ergosterol is an essential component of fungal cell membranes. Inhibition of its production results in:
Isoconazole Nitrate demonstrates activity against a variety of organisms responsible for superficial fungal infections, including susceptible:
Its spectrum and clinical effectiveness depend on the organism and infection being treated.
Isoconazole Nitrate is primarily relevant to the treatment of superficial fungal infections of the skin, including infections associated with dermatophytes and yeasts.
It may be incorporated into topical pharmaceutical formulations such as:
Specific indications depend on the approved formulation and regulatory market.
Typical API manufacturing may involve:
Isoconazole Nitrate API quality evaluation may include:
Isoconazole Nitrate should be stored in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive heat, moisture and direct light. Final storage conditions should be established from validated stability data.
Isoconazole Nitrate is relevant to research involving:
Isoconazole Nitrate is a synthetic imidazole antifungal API with CAS Number 24168-96-5, molecular formula C18H14Cl4N2O·HNO3, and molecular weight 479.14 g/mol. It inhibits fungal ergosterol biosynthesis by targeting lanosterol 14α-demethylase and is primarily used in topical treatment of superficial fungal infections.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| 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 | ≤ 1.5% |
| Water Content | NMT 1.0% |