Miconazole Nitrate is a synthetic imidazole antifungal API used in pharmaceutical formulations for the treatment of various fungal and yeast infections. It acts by interfering with the biosynthesis of ergosterol, an essential component of fungal cell membranes, resulting in disruption of membrane integrity and inhibition of fungal growth.
Miconazole Nitrate is widely associated with topical antifungal pharmaceutical formulations and is available as an active pharmaceutical ingredient for pharmaceutical manufacturing and formulation development.
Miconazole Nitrate is a specialized antifungal pharmaceutical API used in the development and manufacture of topical and other pharmaceutical preparations.
The USP-NF monograph specifies Miconazole Nitrate at 98.0%–102.0% on the dried basis. The USP also specifies limits for loss on drying and residue on ignition.
CAS Number: 22832-87-7
Molecular Formula: C18H14Cl4N2O·HNO3
Molecular Formula (combined): C18H15Cl4N3O4
Molecular Weight: 479.14 g/mol
Drug Class: Imidazole Antifungal
Therapeutic Class: Antifungal Agent
Therapeutic Area: Dermatology / Gynecology / Infectious Diseases
Molecule Type: Synthetic Small Molecule
These identity and molecular data are consistent with PubChem and the USP monograph.
Miconazole Nitrate inhibits fungal lanosterol 14α-demethylase, a cytochrome P450-dependent enzyme involved in ergosterol biosynthesis.
This results in:
Miconazole Nitrate API is used in pharmaceutical development for:
Miconazole Nitrate is used in formulations such as:
Miconazole Nitrate is described pharmacopeially as a white or practically white crystalline powder. The USP-related description reports a melting range of approximately 178–183°C with decomposition.
A controlled Miconazole Nitrate API manufacturing process may involve:
Miconazole Nitrate API quality control may include:
The current USP monograph specifies loss on drying NMT 0.5% and residue on ignition NMT 0.2%. It also specifies optical rotation of −0.10° to +0.10° at 20°C under the stated test conditions.
The USP specifies that Miconazole Nitrate should be preserved in well-closed containers, protected from light, and stored at controlled room temperature.
Miconazole Nitrate is relevant to research involving:
Miconazole Nitrate is an imidazole-class antifungal API with CAS Number 22832-87-7, molecular weight 479.14 g/mol, and a USP assay specification of 98.0%–102.0% on the dried basis. It is primarily used in pharmaceutical formulations for topical treatment of susceptible fungal and yeast infections.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 0.5% |
| Melting Point | 178–183°C |