Description

Sertaconazole Nitrate is a potent synthetic antifungal agent belonging to the imidazole class. Its primary value lies in its broad-spectrum activity against dermatophytes, yeasts, and other fungi, making it a critical active pharmaceutical ingredient (API). This compound is essential for manufacturers in the pharmaceutical and personal care industries developing topical antifungal treatments. Its efficacy and stability profile support the creation of reliable therapeutic formulations for skin and nail infections.

Application

• Primary use as an Active Pharmaceutical Ingredient (API) in the manufacture of topical antifungal creams, ointments, and powders.
• Formulation of prescription and over-the-counter (OTC) medications for treating tinea pedis (athlete's foot), tinea corporis (ringworm), and cutaneous candidiasis.
• Key component in veterinary antifungal products for dermatological conditions in animals.
• Incorporation into specialized personal care and dermocosmetic products targeting fungal-related skin issues.
• Use in clinical and pharmaceutical research for developing new antifungal therapies and delivery systems.
• Potential applications in the preservation of materials susceptible to fungal degradation, subject to formulation and regulatory approval.

Basic Information

Product Name	Sertaconazole Nitrate
CAS No.	99592-32-2
Molecular Formula	C20H15Cl3N2OS • HNO3
Molecular Weight	500.78 g/mol
Synonyms	1-[2-(7-Chloro-1-benzothiophen-3-yl)methoxy]-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole nitrate; Sertaconazole mononitrate; FI-7045; Dermofix; Zalaín; (RS)-Sertaconazole Nitrate; (±)-Sertaconazole Nitrate
EINECS	Contact for details

Quality Control

Our Sertaconazole Nitrate is manufactured and tested to meet high-purity standards suitable for pharmaceutical applications. Quality assurance includes rigorous analytical testing for identity, potency, and impurity profiles. We provide comprehensive Certificates of Analysis (COA) with each batch, detailing results from tests such as HPLC assay, related substances, residual solvents, and heavy metals. Our quality system supports compliance with cGMP guidelines, and we can supply material aligned with relevant pharmacopoeial monographs upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed to prevent absorption of atmospheric moisture. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to almost white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Microbial Enumeration	Complies with Ph. Eur. / USP criteria

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.