Swapnroop Drugs & Pharmaceuticals offers Tioconazole API for pharmaceutical manufacturing and formulation applications. Tioconazole is a synthetic imidazole-class antifungal active pharmaceutical ingredient used primarily in topical pharmaceutical preparations for the treatment of fungal and yeast infections.
Tioconazole is chemically identified as 1-[2-[(2-chloro-3-thienyl)methoxy]-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole. It has the molecular formula C₁₆H₁₃Cl₃N₂OS and molecular weight 387.71 g/mol. The CAS Registry Number is 65899-73-2.
The current USP-NF monograph defines Tioconazole as containing NLT 97.0% and NMT 103.0% of C₁₆H₁₃Cl₃N₂OS.
Tioconazole is a broad-spectrum topical antifungal belonging to the imidazole antifungal class. It inhibits fungal ergosterol biosynthesis by interfering with the fungal cytochrome P450 enzyme lanosterol 14-alpha-demethylase. This disruption affects the fungal cell membrane and inhibits fungal growth.
Tioconazole is used in pharmaceutical formulations for dermatological and vaginal antifungal applications. It has activity against various dermatophytes, yeasts and other susceptible fungi.
| Parameter | Details |
|---|---|
| Product Name | Tioconazole |
| CAS No. | 65899-73-2 |
| Molecular Formula | C₁₆H₁₃Cl₃N₂OS |
| Molecular Weight | 387.71 g/mol |
| PubChem CID | 5482 |
| UNII | S57Y5X1117 |
| Chemical Class | Imidazole derivative |
| Therapeutic Class | Antifungal |
| ATC Code | D01AC07 / G01AF08 |
| Physical Form | Crystalline powder |
| Appearance | White or almost white crystalline powder |
| Chirality | Racemic mixture |
| Main Target | Fungal lanosterol 14-alpha-demethylase |
| Pharmaceutical Use | Topical antifungal preparations |
The molecular formula, molecular weight, CAS number and PubChem CID are confirmed by PubChem, while the pharmaceutical monograph identifies Tioconazole as an antifungal substance.
Tioconazole is used as an active ingredient in pharmaceutical formulations intended for the treatment of susceptible fungal and yeast infections.
Applications include:
Tioconazole is associated with topical treatment of conditions such as ringworm, athlete's foot, jock itch and tinea versicolor, while vaginal formulations are used for vulvovaginal candidiasis.
Tioconazole inhibits the fungal enzyme 14-alpha-demethylase, which is involved in the conversion of lanosterol to ergosterol.
Ergosterol is an important component of fungal cell membranes. Inhibition of its synthesis causes disruption of fungal membrane structure and function, ultimately inhibiting fungal growth.
Swapnroop Drugs & Pharmaceuticals provides Tioconazole API with a quality-focused approach for pharmaceutical manufacturing and formulation requirements.
Quality control can include identity testing, chromatographic assay, related-substance testing, water determination and inorganic impurity testing according to applicable pharmaceutical specifications.
The product can be supported with appropriate quality and regulatory documentation for pharmaceutical customers.
Tioconazole should be packed in suitable pharmaceutical-grade containers that protect the API from contamination and environmental exposure.
The USP monograph specifies:
Packaging: Preserve in tight containers.
For long-term storage of pharmaceutical material, the manufacturer's approved storage conditions and stability data should be followed.
Depending on customer and regulatory requirements, documentation may include:
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0–103.0% |
| Residue on Ignition | NMT 0.2% |
| Individual Impurity | NMT 1.0% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 0.5% |